Keeping Instruments Appropriate for Reprocessing
By Sylvia Garcia-Houchins, RN, MBA, CIC
Editor's note: This column originally appeared in the December 2021 issue of Healthcare Hygiene magazine.
In 2018 approximately 14.4 million operative procedures took place during inpatient stays1 and an estimated 129 million outpatient surgical procedures were performed.2 Add that information to results from an American College of Surgeons study reporting that 5.9 percent of trays delivered to the operating room (OR) contain broken instruments, and the statistics are staggering. It means that during that single year, more than 8 million OR trays potentially contained at least one broken instrument.
The Joint Commission’s infection prevention and control department focuses its efforts on the cleanliness of instruments since we have been taught that, “if it isn’t clean, it isn’t sterile.”3 If there is tissue, bone, or other soil left behind from a prior surgery, the instrument’s unsterile condition could carry risk of infection. The Joint Commission does not just focus on cleanliness of instruments when tracing sterilized instruments. Our surveyors also are trained to determine if an item is appropriate for reprocessing. Since potential exists for organizational liability related to surgical instruments that should not be reused, part of The Joint Commission survey process is to work with customers to identify these potential areas of liability. There are a variety of reasons that surgical instruments are not appropriate for reprocessing including but not limited to: pitting, oxidation, cracks, damaged insulation, or connectors, flaking and sticky tape, and bioburden. ECRI noted that 34 percent of soiled instruments resulted from inadequate cleaning – a violation that should be caught during the instrument inspection process prior to packaging – not at point of use.
In addition to instruments in disrepair making their way to the sterile field, Joint Commission surveyors have noted with increasing frequency the reprocessing of single-use devices (SUDs) – items labeled by their manufacturer as “single-use” or disposable. These devices are often made of lower quality materiel and as a result, develop pitting and oxidation which indicates to the surveyor that something might be amiss. SUD reprocessors are regulated by the Food and Drug Administration (FDA) and are subject to all the regulatory requirements currently applicable to the original device manufacturer, including premarket submission requirements. If a healthcare organization reprocesses a single use device, it is dangerously allowing itself to become a manufacturer of a medical device – and thus assuming all the manufacturer’s liability should that device fail. In addition, it takes on the liability of possible FDA rule violation.
Healthcare organizations follow key measures to ensure that their instruments are appropriate for reprocessing. These include:
• Before reprocessing any device, obtain the manufacturer’s validated reprocessing instructions. Review to ensure they meet the intended level of reprocessing based on intended use of the item and to ensure your organization has the appropriate equipment and products to follow the instructions.
• Ensure staff who are performing inspection are competent and able to perform the inspection process. Ensure staff knows which equipment dismantles and how to inspect it. Healthcare organization leadership should provide staff with good lighting and tools such as lighted magnifiers and other helpful equipment to ensure ample vision while inspecting.
• Empower staff to identify instruments of subpar quality and prevent their use – even if it means delaying or rescheduling affected cases.
• Establish effective maintenance and refurbishment processes to keep instruments in optimal condition. Determine when to remove an instrument that is no longer safe to undergo reprocessing.
• Ensure staff at point-of-use can identify when an instrument should not be used – even if it is in sterile packaging- and how to return and report the occurrence for quality monitoring.
• Train users to appropriately discard SUDs and support the process by ensuring disposal containers at point of use for safe disposal.
• Train users on key issues that can lead to damage of instruments and devices, including erroneously using delicate instruments meant for tissues on other items (e.g., gauze, tape, tubing, etc.), prolonged exposure to blood and other body fluids, or allowing these substances to dry on instruments, use of saline or corrosives such as bleach or inappropriate cleaning chemicals, use of abrasives, or transporting instruments in a way that places them at risk of damage.
• Sometimes instruments are damaged during use. Create and effective process for identifying instruments that require repair or replacement.
• When tracing sterilization practices at your organization, periodically open and inspect instruments in peel pouches and trays to ensure that they are appropriate for sterilization and -use.
• Create a “good catch” reporting process that rewards identification of instruments that should not be reprocessed so that tracking and trending is accurate for budgeting and quality purposes.
Patients face risks related to healthcare every day – do not let use of a soiled, damaged, or inappropriately reused SUD put patients or your health care organization at risk.
Sylvia Garcia-Houchins, RN, MBA, CIC, is director of infection prevention and control at The Joint Commission.
1. McDermott KW, Liang, L. Agency for Healthcare Quality and Research, Healthcare Cost and Utilization Project, Overview of Operating Room Procedures During Inpatient Stays in U.S. Hospitals, 2018. STATISTICAL BRIEF #281 August 2021 Accessed at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb281-Operating-Room-Procedures-During-Hospitalization-2018.jsp
2. Research and Markets. United States Outpatient Surgical Procedures Market 2019-2023: Rising Number of Outpatient Surgical Procedures in ASCs, HOPDs, and Physicians' Office. Jan. 24, 2019 PRNewswire Accessed at: https://www.prnewswire.com/news-releases/united-states-outpatient-surgical-procedures-market-2019-2023-rising-number-of-outpatient-surgical-procedures-in-ascs-hopds-and-physicians-office-300783771.html
3. ECRI If It’s Not Clean, It’s Not Sterile: Reprocessing Contaminated Instruments. Event Reporting & Analysis – Alerts. Published 4/11/2017. Accessed at: https://www.ecri.org/components/PSOCore/Pages/e-lert041117.aspx
The Imperative of a Physician Partner for Every Infection Prevention Program
By Sue Barnes, RN, CIC, FAPIC
This column originally appeared in the November 2021 issue of Healthcare Hygiene magazine.
There are currently tremendous improvement opportunities in the United States relative to the prevention of healthcare-associated infections (HAI), and the resulting patient harm and organizational cost. The Centers for Disease Control (CDC) estimates that HAIs account for an estimated 1.7 million infections and 99,000 associated deaths each year.1 Prevention of HAI can result in savings of between $1,000 and $40,000 per patient depending on the specific infection and healthcare setting.2 Many variables affect the success of an IP program including the strong partnership between the infection prevention department and an infectious diseases (ID) physician.3,4
In many U.S. hospitals, an ID physician serves as the chairperson or co-chairperson of the infection prevention committee and may also assist the IP department as an advisor and partner. Where it exists, this role is often not compensated.5,6 “Administrative time” is sometimes granted, but this time may or may not be spent in activities supporting the infection prevention program. The same ID physician is typically responsible for the antibiotic stewardship program (ASP) as well as clinical patient care including ID consults, which are each separate and apart from the infection prevention program.
In a 2015 study assessing physician resourcing for ASP and infection prevention, the researchers reported an average staffing level for the combined programs of 1.21/100 beds.7 Five years later, in a study by Stone still in press, only 49 percent of the hospitals reported the presence of a physician partner for the IP program, and most (71 percent) were only part-time.8
The Society for Healthcare Epidemiology of America (SHEA) whitepaper from 2015 states, “To effectively serve in these various roles, the physician partner for infection prevention programs requires formal support to protect time and effort for training activities and professional development.”9 However, in the absence of a regulatory mandate this does not happen universally. There is currently no requirement by the Centers for Medicare and Medicaid Services (CMS) or The Joint Commission (TJC) for a physician partner for infection prevention programs, at the local and/or corporate level.
Unfortunately, even when there is an ID physician designated to assist the infection prevention program, there is no guarantee that the physician has had the appropriate training regarding prevention and control of HAI, including outbreak investigation. There is currently no regulatory requirement for training of these physicians, and no process for certification. The Infectious Diseases Society of America (IDSA) offers an online course, though references the Association for Professional in Infection Control and Epidemiology (APIC) guidelines for specifics.10 SHEA also offers an online course, though covers only the basics.11 Neither provides certification.
Similarly, to date there is no standard role description for the physician partner for infection prevention programs in the U.S. However, there have been commentary and guidelines published. For example, the 2015 SHEA whitepaper proposes that the competencies required for this position should include:
• Data management and surveillance
• Microbiology and laboratory diagnostics
• Outbreak investigation
• Prevention and control of healthcare associated infections
• Quality improvement science
• Training and teaching methods and principles9
These competencies translate to a myriad of responsibilities which vary greatly from hospital to hospital, even within the same integrated delivery network (IDN). In addition to the core responsibilities of the ID physician (i.e., clinical patient care, antibiotic stewardship, ID consults), functions supporting the infection prevention department commonly include one or more of the following:
• Meet regularly with the infection prevention team to review ongoing issues/opportunity areas/work plan status
• Co-chair the Infection Prevention and Control Committee
• Co-Lead annual infection prevention work plan development based on results of risk analysis
• Partner with the infection prevention team on key performance improvement projects
• Interface with physicians to ensure compliance with products and practices supporting the infection prevention program (e.g., hand hygiene, isolation and personal protective equipment (PPE) use, disinfection and sterilization, line insertion, surgical prep)
• Provide physician training relative to infection prevention and control and outbreak investigation/mitigation
• Provide HAI case validation as needed by infection preventionists
• Partner with infection prevention program director to provide regular status reports to the local executive team (e.g., executive committee)
• In partnership with the infection prevention director, and execute authority as needed in the interest of patient safety (e.g., close the operating room or other units in the event of outbreak of infection, exposure, etc.)
A federal mandate for a dedicated ID physician for every local and corporate level infection prevention program would help to ensure that patient safety is supported with this critical role. This would in turn support the goal of zero preventable HAIs, with the associated reduction of patient suffering and healthcare costs. To best support reliable design, the mandate would ideally also require standard training and certification, development of a standard role description, and dedicated resourcing. It would seem reasonable to think that APIC, SHEA and IDSA could collaborate to support this.
1. Patient Care Link: https://patientcarelink.org/improving-patient-care/healthcare-acquired-infections-hais/
2. Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013 Dec 9-23;173(22):2039-46. doi: 10.1001/jamainternmed.2013.9763.
3. McQuillen DP, Petrak RM, Wasserman RB, Nahass RG, Scull JA, Martinelli LP. The value of infectious diseases specialists: non-patient care activities. Clin Infect Dis. 2008 Oct 15;47(8):1051-63. doi: 10.1086/592067.
4. Barnes S, Spencer M. Reliable design of IP programs, Infection Control Today. Sept 2015. pp 41-43.
5. Zahn M, Adalja AA, Auwaerter PG, et al. Infectious Diseases Physicians: Improving and Protecting the Public's Health: Why Equitable Compensation Is Critical. Clin Infect Dis. 2019;69(2):352-356. doi:10.1093/cid/ciy888
6. Wright S. et al. Expanding Roles of Healthcare Epidemiology and Infection Control in Spite of Limited Resources and Compensation. Infection Control and Hospital Epidemiology. February 2010, vol. 31, no. 2.
7. Dickstein Y, Nir-Paz R, Pulcini C, Cookson B, Beović B, Tacconelli E, Nathwani D, Vatcheva-Dobrevska R, Rodríguez-Baño J, Hell M, Saenz H, Leibovici L, Paul M. Staffing for infectious diseases, clinical microbiology and infection control in hospitals in 2015: results of an ESCMID member survey. Clin Microbiol Infect. 2016 Sep;22(9):812.e9-812.e17. doi: 10.1016/j.cmi.2016.06.014. Epub 2016 Jun 29.
8. Stone PW, Dick A, Pogorzelska M, Horan TC, Furuya EY, Larson E. Staffing and structure of infection prevention and control programs. Am J Infect Control. 2009 Jun;37(5):351-357. doi: 10.1016/j.ajic.2008.11.001.
9. Kaye K et al. Guidance for Infection Prevention and Healthcare Epidemiology Programs: Healthcare Epidemiologist Skills and Competencies. Infect Control Hospital Epidemiol. Volume 36, Issue 04. April 2015, pp 369 – 380.
10. IDSA online course https://www.idsociety.org/clinical-practice/infection_prevention_and_control/infection-prevention-and-biopreparedness/
11. SHEA online course: https://www.shea-online.org/index.php/education/10-education/62-online-education
Safe Injection Practices in Ambulatory Care Settings
By Margaret M. Miller, BS, MT (ASCP) M, CIC, FAPIC, and Christina Michalek, BS, RPh, FASHP
This column originally appeared in the October 2021 issue of Healthcare Hygiene magazine.
Injection safety is a set of practices followed to perform injections in a manner that is safe for patients, staff, and others. Injection safety also includes practices to prevent sharps injuries and contamination of medications.
The primary objective in injection safety is preventing transmission of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). In response to the HIV/AIDS epidemic in the early-mid 1980s, Universal Precautions were created by the Centers for Disease Control and Prevention (CDC) and applied blood and body fluid precautions to all patients, regardless of infection status. Universal Precautions guidelines recommended the use of personal protective equipment to protect mucous membranes, hand hygiene, and methods for safely handling needles and other sharp devices; this concept became integral to the Occupational Safety and Health Administration (OSHA)’s 1991 regulation on occupational exposure to bloodborne pathogens in healthcare settings. In 1996, the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Isolation Precautions in Hospitals replaced Universal Precautions with Standard Precautions, which we continue to follow to this day.
OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) revision in 2001 specified in greater detail the engineering controls, such as non-needle devices and other safety features, which must be used to reduce or eliminate worker exposure. The standard places these requirements on employers whose workers can reasonably anticipate contact with blood or other potentially infectious materials.
Despite recommendations from HICPAC and OSHA, outbreaks and patient exposures to potentially infectious bodily fluids continue to be reported. The largest outbreak of HCV occurred at an outpatient endoscopy center where a cluster of patients developed acute HCV infection after their procedures. An investigation uncovered unsafe injection practices including reuse of patient syringes to access propofol vials. The single-dose vials (SDVs) were then reused for subsequent patients, transmitting potentially contaminated medication to those patients. More than 50,000 patients were notified of exposure and the need for HBV, HCV, and HIV testing. The final cost of the outbreak was estimated to be $16 million to $21 million. In the end, every exposure was preventable and would not have occurred if staff had adhered to established safe injection practices.
Safe Injection Practices
Following safe injection practices and aseptic technique during the preparation and administration of medications is a priority. Always perform hand hygiene and work on a clean surface, preferably in a separate medication preparation area, not in a patient-care area. Other essential elements include:
• Never administer medications from the same syringe to more than one patient, even if the needle is changed. Needles and syringes are sterile, single-use items
• Never enter a vial with a used syringe or needle
• Do not use bags of intravenous (IV) solution as a common source of supply for more than one patient
• Limit the use of multi-dose vials (MDVs) and dedicate them to a single patient whenever possible
• Always use facemasks when injecting material or inserting a catheter into the epidural or subdural space
• Prepare injectable medications as close as possible to the time of administration, rather than in advance
Procedures identified as prone to unsafe injection practices include:
• Administration of sedatives and anesthetics for surgical, diagnostic, and pain management
• Administration of IV medications for chemotherapy, cosmetic procedures, and alternative medicine therapies
• Use of saline solutions to flush IV lines and catheters
• Administration of joint injections
Medication Safety Recommendations for Ambulatory Care Settings
Employ safe practices for IV push medications:
• Do not further dilute IV push doses of medication unless recommended by the drug’s manufacturer or supported by evidence in peer-reviewed biomedical literature
• Label all clinician-prepared syringes of IV push medications
• Never pre-label empty syringes in anticipation of use
• To the maximum extent possible, purchase commercially prepared, premixed parenteral products
Take steps to safeguard controlled substances:
• Stock the smallest sized container necessary to provide the typical ordered dose of a controlled substance to minimize the need for drug waste and limit the potential for diversion
• Proactively monitor controlled substance usage, waste procedures, and documentation
• Place sharps/pharmaceutical waste containers in areas where they can be consistently observed. Select containers with small openings that do not allow medication devices or waste to be shaken out, and where possible, secure containers so they cannot be easily removed
Avoid patient harm when using single- and multiple-dose vial containers:
• SDVs should be used on a single patient and should be discarded after use
• Ideally, even MDVs should be used for only 1 patient. If used for multiple doses, discard the MDV when the beyond-use-date, or the expiration date, is reached and any time the sterility of the vial is in question
Support a positive safety culture:
• Encourage staff to identify and report near miss/close call events as well as actual errors
• Share lessons learned about underlying weaknesses in processes, systems, or equipment that explain why an error happens
• Train, monitor, and coach staff on best practices
In addition to injection and medication safety, there are additional practices that can protect the worker from occupational injuries. Contaminated sharps should not be bent, recapped or removed. Sharps should be disposed of as soon as possible after use. Disposal receptacles should be puncture resistant, labeled as biohazardous, leak-proof, and closable. Containers should be located as close as possible to the area of use and be large enough to fit a contaminated sharp without bending. Additionally, these receptacles should not be allowed to overfill, as doing so prevents the lid from closing properly.
Employers should maintain a confidential sharps injury log to document percutaneous injuries from all sharps. The event reporting system should document the type and brand of device involved in the incident, the work area where the exposure incident occurred, and an explanation of how the incident occurred.
ECRI is affiliated with the Institute for Safe Medication Practices (ISMP), a global leader in medication safety. For more than 25 years, ISMP’s research and advocacy have improved clinical practices and policies to prevent critical medication safety errors and adverse events. ECRI is available to assist facilities. Visit www.ecri.org.
• Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care
• Outbreak of Hepatitis C at Outpatient Surgical Centers. Public Health Investigation Report. December 2009. Southern Nevada Health District Outbreak Investigation Team, Las Vegas, Nevada. Available at: http://southernnevadahealthdistrict.org/download/outbreaks/final-hepc-investigation-report.pdf.
• Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007)
• CDC’s Injection Safety
• CDC’s One & Only Campaign
• Institute for Safe Medication Practices
• OSHA Bloodborne Pathogens and Needlestick Protection
Margaret M. Miller, BS, MT (ASCP) M, CIC, FAPIC, is an infection preventionist with ECRI.
Christina Michalek, BS, RPh, FASHP, is a medication safety specialist at the Institute for Safe Medication Practices (ISMP).
Reprocessing Ultrasound Transducers
By Diane Cullen, RN, MSN, MBA, CIC
Editor's note: This column originally appeared in the September issue of Healthcare Hygiene magazine.
The Joint Commission receives many inquiries from healthcare organizations asking how to reprocess medical devices, and more specifically, about the requirements for reprocessing ultrasound transducers. Examples of questions received include: What level of reprocessing is required? What do I do if the manufacturer’s instructions indicate a level of reprocessing that does not match my use of the transducer? What ultrasound transducer reprocessing practices are surveyors looking for?
The Joint Commission has recently published an article which addresses reprocessing practices for ultrasound transducers (published in the July 2021 issue of Joint Commission Perspectives.) The article describes some common survey observations regarding ultrasound transducers as well as related standard and element for performance (EP) scoring locations. To develop procedures for reprocessing transducers and to remain compliant with The Joint Commission Standards, organizations are encouraged to follow The Infection Prevention Hierarchy. The Hierarchy is a systematic approach which, when followed, will ensure an organization has considered local, state, and federal regulations (which may require organizations to follow specific evidence-based guidance), Centers for Medicare and Medicaid Services (CMS) Conditions of Participation, and abides by (or resolves conflicts with) the manufacturer's instructions for use (IFU) for any specific product.
Because ultrasound transducers are medical devices, they are regulated by the Food and Drug Administration (FDA). The FDA has published a guidance document specific for diagnostic ultrasound devices which refers to another guidance document: Reprocessing Medical Devices in health Care Settings: Validation Methods and Labeling. This document uses the Spaulding Classification System to guide device manufacturers when developing reprocessing instructions for medical devices based on the intended use of the device. For example, ultrasound transducers (transducers) may be used on intact skin, mucous membranes or within sterile body cavities or tissues during procedures. Each of these intended uses would result in a different requirement for reprocessing, based on Spaulding criteria:
• If a transducer is used in a sterile body cavity or sterile tissues, it is considered a critical device and requires sterilization.
• If a transducer is used on non-intact skin or mucous membranes, such as a vaginal, rectal or oral, it is a semi-critical device and should undergo high-level disinfection.
• If a transducer is only used on intact skin, it is considered non-critical and, regardless of whether it is contaminated with blood, the minimum requirement is low level or intermediate level disinfection.
• If the transducer manufacturer reprocessing instructions indicate that an instrument should be high-level disinfected if used to assist with percutaneous procedures or if contaminated with blood, the organization must follow the manufacturer instructions for use unless they have evidence to negate that instruction from the manufacturer.
A transducer sheath (probe cover), considered a medical device by the FDA, must be approved for use as a barrier. Transducer sheaths cannot be interchanged with items that have not been approved for barrier use (e.g., transparent IV dressings) and are intended to be used during procedures to protect the transducer from body fluids. Sheaths are applied to surface transducers, endocavity transducers or transducer probes used in surgical procedures. There has been debate whether the use of a transducer sheath on any transducer would negate the need to perform the minimum level of disinfection specified in the reprocessing instructions, as required by the manufacturer. The FDA has stated that use of a transducer sheath does not affect the Spaulding Classification of the transducer (as these sheaths may leak or tear) and therefore would not change the minimum level of reprocessing required for the transducer based on clinical use, unless otherwise indicated by the manufacturer.
The Joint Commission expects all organizations to comply with instructions provided by the manufacturer based on intended use of the device. However, there are times that the device manufacturer’s instructions might not conform to rules about intended use (Spaulding Classification System) or may not provide enough information for the end user to determine the correct method for reprocessing. If these situations occur, then contact the manufacturer. If there is a question or possible conflict with the instructions provided, then it is the healthcare organizations responsibility to refrain from using the device until the manufacturer is contacted and differences are reconciled. It is also important to remember that if alternative instructions are provided to a staff member during conversation with the manufacturer, he or she should obtain those instructions in writing and present them at the time of survey.
In addition, if the manufacturer requires a specific product, The Joint Commission surveyor will look for that product at a healthcare organization or expect an organization to have contacted and resolved any issue related to compatibility of products used. If the manufacturer requires a certain time or temperature for reprocessing, The Joint Commission will expect a healthcare organization to establish a means and process to measure both.
Healthcare organizations could be cited for:
• Failing to produce the IFUs of medical equipment and devices reprocessed at the organization,
• Failing to follow the steps of cleaning and reprocessing described in the IFU (if no steps have been taken to resolve deviation)
• Failing to use the products indicated in IFU (unless compatibility of alternative products has been confirmed)
• Failing to provide adequate personal protective equipment to staff (per IFU and hazard assessment) to complete the reprocessing and
• Failing to provide training or assessment of competence for staff who perform those procedures.
The Joint Commission understands that instrument handling and processing can be complex and are available to help. We encourage healthcare staff to contact an infection preventionist at The Joint Commission with any questions at Ask SIG.
Diane Cullen, RN, MSN, MBA, CIC, is assistant director of the Standards Interpretation Group for The Joint Commission.
A Call for Standardized Automation: HAI Surveillance in the 21st Century
By Sue Barnes, RN, CIC, FAPIC
Editor's note: This column originally appeared in the August 2021 issue of Healthcare Hygiene magazine.
Prevention and control of healthcare-associated infections (HAIs) became a greater priority in U.S. hospitals after publication of the 1999 Institute of Medicine (IOM) report, To Err is Human, which focused on avoidance of preventable harm.1 One component of infection prevention and control (IP&C) programs is surveillance of HAIs, which was originally the primary function of the infection preventionist (IP). However, the scope of these programs has massively expanded ever since, with prevention and control of infections now the primary imperative, and surveillance just one tool. Infection surveillance data is used to measure the success of IPC interventions, to identify areas for improvement, to assess the benefit of innovative products and practices, and to meet public reporting mandates and pay for performance goals. In hospitals where semi-automated infection surveillance software is not available, HAI surveillance is accomplished manually. Both methods provide data which can be subject to inter-rater reliability deficiency, inaccuracy, and for the manual process subjectivity as well. 2,3
For manual surveillance these limitations are due in part to variable interpretation of the complex HAI definitions, but also to simple human error. In addition, though HAI definitions are standardized by the Centers for Disease Control and Prevention (CDC), the process for manual infection detection has never been standardized. Similarly, for infection surveillance software there is no standard infection detection algorithm, and this is variable among the many software programs. In addition, infection surveillance software report accuracy is dependent upon the completeness of clinical documentation in the electronic medical record (EMR).
Legislative Support and Funding for Infection Prevention and Control
The Health and Human Services department (HHS) recently announced an $80 million plan focused in part on information technology (IT) development, but for the public health sector, not hospitals.4 The current HHS National Action Plan to Prevent HAI addresses the limitations of hospital based HAI surveillance processes in general terms, though not cost of infection surveillance software or the lack of algorithm standardization for infection detection.5 The 2022 HHS Justification of Estimates for Appropriations Committees report reflects that there is $35.7 million designated to advance the generation of new knowledge and promote the application of proven methods for preventing HAIs.6 However, there is no mention of directing any of these funds toward standardizing algorithms for electronic HAI surveillance, or making these systems equally available to all hospitals.
Technology - Automated vs. Manual Surveillance and the Need for Standardization
The advent of automated infection detection by applying data mining algorithms to the EMR or via specialized add-on infection surveillance software has been shown to improve the quality of HAI data, reduce the time required when compared to manual infection surveillance, as well as assist in early outbreak identification.7-10 And given the data reporting burden of the CDC’s National Healthcare Safety Network (NHSN), the additional automation of data export to NHSN is reported to further protect IP&C resources.11 However, automation requires a level of information technology (IT) support not always accessible to IP&C departments, which in addition to the cost of these programs has resulted in slow adoption.12 In 2014 it was estimated that only 45 percent of U.S. hospitals used electronic infection surveillance systems.13 And many of the software programs available today do not completely eliminate the need for manual record review to confirm case finding. Kenrick Cato, a researcher at the Columbia University School of Nursing has proposed that, “If monitoring systems could be fully automated, it would revolutionize the way infection surveillance is done.”13 One study reports that this has be done in at least one location, further concluding that “automated detection of HAIs according to NHSN surveillance definitions, can bridge the gap between retrospective surveillance of HAIs and prospective clinical-decision-oriented HAI support.”14,15 According to a 2020 study, we are still at least a decade away from widely utilizing electronic HAI surveillance due in part to lack of focus and funding by government, which could make automated surveillance available to every hospital IP&C department.16
HAI surveillance remains central to prevention and control efforts; however, HAI case finding as well as reporting to NHSN is resource-intensive, subject to inaccuracy due human error, and is hampered by a lack of standardization of manual and automated infection detection processes, which also challenges accurate inter-facility comparison. In addition, HAI data is retrospect, which prevents intervention in real time to expedite effective treatment.
To ensure that HAI data serves to optimally support IPC programs and meet reporting requirement, improvements in surveillance systems must keep pace with the technology available. The path to this end point would be expedited with government dollars directed in support of fully automated and standardized HAI surveillance, made available to all US hospitals.
In the short term this will require hospital executives partnering with IPC departments to leverage the rapidly evolving field of infection detection software to ensure best use of resources.
Sue Barnes, RN, CIC, FAPIC, is an independent clinical consultant.
1. Maaike S, van Mourik M, Perencevich EN, et al. Designing Surveillance of Healthcare-Associated Infections in the Era of Automation and Reporting Mandates. Clin Infectious Dis. Vol. 66, Issue 6. March 15, 2018, Pp. 970-976. https://doi.org/10.1093/cid/cix835
2. Nuttall J, et al. The inter-rater reliability of the diagnosis of surgical site infection in the context of a clinical trial. Bone Joint Res. 2016 Aug;5(8):347-52.
3. Lin MY, Hota B, Khan YM, et al. Quality of traditional surveillance for public reporting of nosocomial bloodstream infection rates. JAMA. 2010 Nov 10;304(18):2035-41.
4. HHS. $80 Million in Funding https://www.hhs.gov/about/news/2021/06/17/hhs-announces-80-million-in-arp-funding-to-bolster-underrepresented-communities-in-public-health-it-workforce.html
5. National HAI Action Plan. https://health.gov/our-work/health-care-quality/health-care-associated-infections/national-hai-action-plan
6. AHRQ Mission Budget 2022. https://www.ahrq.gov/sites/default/files/wysiwyg/cpi/about/mission/budget/2022/FY2022_CJ.pdf
7. Branch-Elliman W, Strymish J, Gupta K. Development and validation of a simple and easy-to-employ electronic algorithm for identifying clinical methicillin-resistant Staphylococcus aureus infection. Infect Control Hosp Epidemiol. 2014 Jun;35(6):692-8.
8. DeLisle S, Kim B, Deepak J, et al. Using the electronic medical record to identify community-acquired pneumonia: toward a replicable automated strategy. PLoS One. 2013 Aug 13;8(8):e70944.
9. Pramono RX, Imtiaz SA, Rodriguez-Villegas E. A Cough-Based Algorithm for Automatic Diagnosis of Pertussis. PLoS One. 2016 Sep 1;11(9):e0162128.
10. Salmon M, Schumacher D, Burmann H, et al. A system for automated outbreak detection of communicable diseases in Germany. Euro Surveill. 2016;21(13).
11. Vostok J, Lapsley W, McElroy N, et al. Assessment of the burden of mandatory reporting of health care-associated infection using the National Healthcare Safety Network in Massachusetts. Am J Infect Control. 2013 May;41(5):466-8. doi: 10.1016/j.ajic.2012.05.021
12. Hebden JN. Slow adoption of automated infection prevention surveillance: are human factors contributing? Am J Infect Control. 2015 Jun;43(6):559-62.
13. Levingston S. Software That Helps Spot Sneaky Infections. Bloomberg Terminal online. Dec. 18, 2014. https://www.bloomberg.com/news/articles/2014-12-18/software-that-fights-infections-in-humans-at-the-hospital
14. Koller W, de Bruin JS, Rappelsberger A, et al. Advances In Infection Surveillance and Clinical Decision Support With Fuzzy Sets and Fuzzy Logic. Stud Health Technol Inform. 2015;216:295-9.
15. Classen D, Li M, Miller S, et al. An Electronic Health Record–Based Real-Time Analytics Program for Patient Safety Surveillance and Improvement. Health Affairs. Vol 37., No 11. November 2018. https://doi.org/10.1377/hlthaff.2018.0728
16. Streefkerk H, Roel A, Verkooijen Roel PAJ, et al. Electronically assisted surveillance systems of healthcare-associated infections: a systematic review. Euro Surveill. 2020;25(2):pii=1900321. https://doi.org/10.2807/1560-7917.ES.2020.25.2.1900321
What You Need to Know when Considering Supplemental Methods for Terminal Room Disinfection: Ultraviolet-C Light Versus Hydrogen Peroxide Vapor
By Margaret M. Miller, BS MT (ASCP) M CIC FAPIC
Editor's note: This column originally appeared in the July 2021 issue of Healthcare Hygiene magazine.
For tables, see the July 2021 issue at: https://www.healthcarehygienemagazine.com/monthly-issues/
Many facilities seek to reduce healthcare-associated infections (HAIs) and transmission of viruses, multi-drug resistant organisms (MDROs), Clostridioides difficile (C. difficile) and other pathogens. The COVID-19 pandemic has highlighted the importance of environmental cleaning. To properly disinfect, one must manually clean visibly dirty surfaces prior to disinfection, use an EPA-approved disinfectant, and follow the application and dwell time instructions on product labels. There may be practice gaps in environmental cleaning practices, knowledge gaps in disinfection methods, and product variability due to supply chain challenges.
Supplemental no-touch disinfection methods provide an additional level of environmental decontamination following routine surface cleaning and disinfection. Here we will discuss considerations for implementing two of these technologies: Ultraviolet-C light (UV-C) and hydrogen peroxide vapor (HPV). Studies have shown when used after manual cleaning, UV-C and HPV disinfection methods significantly reduce contamination on environmental surface pathogens such as MDROs and C. difficile.
Supplemental disinfection devices decrease reliance on operators and potentially improve the efﬁcacy of environmental surface cleaning, and specifically, terminal room disinfection. These devices are intended to supplement good cleaning protocols already in place, not to replace routine cleaning.
Implementation and operational considerations
Workflows for UV-C and HPV methods are similar; however, HPV requires additional steps and precautions. Both supplemental methods require the room to be unoccupied, manual cleaning and disinfection performed, room preparation, and cycle time. Key criteria for UV-C room disinfection are dose delivery, motion sensors with auto shut-off for safety, maneuverability, and lamp damage protection. HPV devices may be mobile or permanently installed in a space. HPV requires heating, ventilation, air conditioning vents and smoke detectors be blocked. Doors to the space must be sealed with tape to prevent HPV leakage. After the HPV cycle, a hydrogen peroxide sensor is used to verify the chemical concentration is less than one part per million (the exposure limit permitted by the Occupational Safety and Health Administration) prior to room entry.
Relative advantages and disadvantages of UV-C and HPV disinfection
Regardless of the type of supplemental disinfection device, thorough cleaning is required before the device is used because inorganic and organic materials that remain on surfaces interfere with the effectiveness of the process.
For UV-C technology, advantages include ease of use, the documented studies showing pathogen reduction in the environment after outbreaks and with high-risk pathogens in high-risk units, and the relatively quicker cycle times compared to HPV technology. As considerations for disadvantages, UV-C technology requires time, energy and expenses to implement effectively. Use increases room downtime between patients, compared to no supplemental disinfection, and its effectiveness may vary based on positioning in the area and system settings. Lastly, UVC disinfection is limited to solid surfaces, and some pathogens (Candida auris, C. difficile) may require longer exposure times.
For HPV technology, the system’s effectiveness is not affected by physical constraints or shadows and thus can effectively disinfect an enclosed space within one cycle. Unlike UV-C disinfection, HPV can be used with both compatible porous and non-porous surfaces. For disadvantages compared to UV-C disinfection, use of HPV increases room downtime and may last several hours depending on size and the need for the operator to seal all HVAC vents, smoke detectors, and outer doors. Lastly, HPV may damage medical and nonmedical equipment if hydrogen peroxide is not approved for use in manufacturer’s instructions for cleaning. Items not compatible must be appropriately covered or removed from the room during disinfection.
In summary, the COVID-19 pandemic has increased interest in supplemental disinfection devices for use in various healthcare settings. ECRI member interest more than doubled in 2020. Organizations may buy and implement these systems without full knowledge of the requirements for safe and effective system use. Misuse of devices can result in human chemical exposure and potential damage to sensitive devices, equipment, and items. It is important to select the type of system that meets your needs, develop an implementation plan, and identify high-risk areas for use to strategize to reduce bioburden and healthcare related infections in your facility.
UV disinfection systems are not classified as medical devices and therefore are not regulated by the Food and Drug Administration. Furthermore, there are no standardized test methods for comparing systems so your team may need help. Facilities should regard manufacturer claims critically; be sure to read the fine print, and look for citations that provide study details. ECRI is available to assist facilities through the process of device selection, implementation and assessing the effectiveness of a device in your space. Visit www.ecri.org and follow @ECRI_Org on Twitter.
Margaret M. Miller, BS, MT (ASCP)M, CIC, FAPIC, is an infection preventionist with ECRI.
CDC. Disinfection and Sterilization. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/ . Accessed June 25, 2021.
US Agency for Healthcare Research and Quality. No-Touch Modalities for Disinfecting Patient Rooms in Acute Care Settings: A Rapid Review. Oct 2020.
The Lancet. D Anderson et al. Effectiveness of targeted enhanced terminal room disinfection on hospital-wide acquisition and infection with multidrug-resistant organisms and Clostridium difficile: a secondary analysis of a multicentre cluster randomised controlled trial with crossover design (BETR Disinfection). August 2019.
ECRI. Dry Hydrogen Peroxide Disinfection Systems for Reducing Healthcare-associated Infections. November 2020.
ECRI. Evaluation Background: UV Room Disinfection Devices. Updated April 2020.
Department of Industrial Relations. Permissible Exposure Limits for Chemical Contaminants. Accessed June 25, 2021.
ECRI. Ultraviolet Light Air-purification Systems for Preventing Healthcare-associated Infections. March 2020.
ECRI. Using UV Disinfection Safely and Effectively: Technology Challenges during the COVID-19 Pandemic. May 2020.
American Journal of Infection Control (AJIC). D Weber et al. Effectiveness of ultraviolet devices and hydrogen peroxide systems for terminal room decontamination: Focus on clinical trials. May 2016.
ECRI. Use of Automatic Chemical Disinfection Systems May Lead to Chemical Exposure and Equipment Damage. July 2020.
ECRI. UV Room Disinfection: Estimating Labor Costs and Understanding Common Use Scenarios. October 2017.
Preparation for Survey: Tips for Infection Preventionists
By Sylvia Garcia Houchins, MBA, RN, CIC
Editor's note: This column originally appeared in the June 2021 issue of Healthcare Hygiene magazine.
It is difficult for an infection preventionist (IP) to anticipate what to expect during a healthcare organization’s survey. With more than 30 years of experience as an IP, I have personally participated in 10 full, unannounced Joint Commission surveys, a few for-cause Joint Commission surveys, three intense occupational health and safety visits, and several state surveys. So, how does one become “good at survey” when the opportunities may be few and far between?
During the first few surveys, I was allowed to accompany the physician, nurse, administrator, and life safety surveyor. All were terrific teachers, and I learned a lot from each. The experience also prepared me to act as a “guide” for surveyors during subsequent surveys and provided me the confidence to explain to surveyors why I did not think my organization was out of compliance with the Joint Commission standards or Centers for Medicare and Medicaid Services’ (CMS) Conditions of Participation (CoP).
IPs should be proactive in asking to be allowed to participate in surveys and should not wait to be asked. Instead, IPs should volunteer to participate in mock surveys – even if they are not infection control- related. The experience will help provide information on how an organization functions during survey, its processes that are in place, who is who on its team, as well as the survey process itself.
IPs should use a systematic approach to determining compliance with regulatory requirements. For example, before working at the Joint Commission, and while working as a consultant, I helped many organizations prepare for their surveys and respond to adverse survey results including immediate jeopardy. I always followed a hierarchical approach to compliance. First, I determined if there was a law or regulation that applied, followed by ensuring compliance with CMS CoPs that included researching and interpreting instructions for use and seeking clarity from manufacturers. Then, if needed, I always turned to locating supporting literature, evidence-based guidelines, and best practices to help.
In April 2019, this approach was published in the Joint Commission’s publications, Perspectives, to help organizations learn how become compliant with Joint Commission infection prevention and control standards and to provide a good starting point for preparing for a survey. But, merely following the approach is not enough. Most IPs are incredibly dedicated and resourceful, but I find that many overthink or underthink what is required for survey. Below are some “tips” that will help an IP prepare for survey.
1. Make sure your organization can provide evidence that the IP is qualified and competent. There is an important distinction between qualified and competent and we often find that organizational leadership does not understand the difference. The following information provides clarity on the differences as well as an example of what could be identified as an issue during survey.
Qualifications: Healthcare organizations must define an IP’s qualifications based on his or her specific-to-job responsibilities. Qualifications for infection control may be met through ongoing education, training, experience and/or certification. For example, organizations may define an IP’s qualifications as “ongoing experience practicing in the infection prevention and control field as well as initial and ongoing infection prevention-specific education and training.” Or, they may require that, “The IP has three years of experience in a surgical setting and certification in infection prevention and control or able to obtain certification within two years of hire.”
Competency: This (see Joint Commission standard HR.01.06.01) differs from education and training in that competency incorporates knowledge, technical skills, and ability. All are required to deliver safe care correctly and perform technical tasks. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task consistent with the education and training provided. An example of a competency assessment could be the validation that an IP can perform surveillance correctly by providing cases studies and determining that the IP correctly identifies whether the case meets the definition of a healthcare-associated infection. Competency may also include, confirming that he or she correctly identifies the type of infection, correctly calculates infection rates, and presents results in a clear manner with relevant interpretation.
A common mistake that is scored during survey happens when an IP who is not competent themselves, signs off on the competency of a person who is performing a task, for example high-level disinfection or sterilization. The IP may be knowledgeable or have training related to disinfection and sterilization, but he or she is not competent to perform the tasks and identify and problem solve when issues arise. In the example, of sterilization, the IP knows the basic steps for reprocessing instruments but could not assess that each step is being done correctly or how to identify that an instrument or piece of equipment should be taken out of service.
2. It is necessary for an IP to thoroughly understand his or her primary resources. Some of the most important resources include:
• Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings – Recommendations of the Healthcare Infection Control Practices Advisory Committee, 2017. Section five of this document explains requirements of standard precautions but more importantly it provides a framework for infection prevention and control in any health care setting.
• OSHA Bloodborne Pathogens Standard and Personal Protective Industry Standard. These standards are required by law. All accredited organizations must comply with state and federal laws and regulations.
• Centers for Disease Prevention and Control (CDC) Guidelines and Guidance Library. This is the best place to search for FREE evidence-based guidance.
• Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the HICPAC. This is an important webpage for any organization that reprocesses flexible endoscopes.
• Manufacturer instructions for use for any medical device, supply or equipment that needs to be or is used to clean, disinfect, or sterilize.
These resources provide basic information to guide development of any organization’s infection control plan.
3. IPs should perform tracers like a Joint Commission surveyor does. Surveyors don’t follow a checklist; they ask open-ended questions and determine through the answers how to identify risks. For example, an IP might perform a “procedure” tracer. In doing so, he or she selects a device in sterile processing that is used by a clinic. Then the IP asks the clinic nurse or medical assistant what procedure(s) are conducted in the clinic with that device and with what additional equipment or devices does he or she prepare for the procedure? This provides context for how the devices are used.
IPs should watch how the health care organizations staff prepares a room for the next patient. They should also ask for instructions for use and if they are easily available. Then, review them to determine if items were used, discarded, or reprocessed in accordance with the instructions. Make sure that the reprocessing level and intended use match for everything used. If an item is cleaned, disinfected, or sterilized, follow it through the process, ask open ended questions without assuming know the answer. Don’t make assumptions. Ask clarifying questions, like: Does it make sense? IPs should make sure that they thoroughly understand the processes involved and identify any risk points. Then they can use the information to identify other “threads to pull” prioritize and mitigate risks.
4. Access resources that The Joint Commission offers through www.jointcommission.org Scroll to the bottom of the page to find a link to the Joint Commission Connect website. Every Joint Commission-accredited health care organization has access. If your organization cannot access, ask your accreditation manager to give you access. Through this website you can access:
• E-dition is the electronic version of the Joint Commission standards and all IPs should access to determine the standards that apply to their organization.
• Perspectives is the official publication of the Joint Commission. If an infection control process or scoring example is addressed in this publication it is important that the IP or accreditation team evaluate organizational compliance. A recent example is Blood Glucose Monitoring and Insulin Administration which was published in the Consistent Interpretations section. The CDC has issued multiple alerts that unsafe practices during assisted monitoring of blood glucose and insulin administration place people at risk of transmission of bloodborne viruses (HBV, hepatitis C virus, and HIV) and have since 2008, linked these unsafe practices to outbreaks of viral hepatitis related to healthcare, including Personal Care Homes, Assisted Living, Home Care Agency, Long-term Care. Review of scoring has identified knowledge gaps amongst providers and\or leaders that have resulted in unsafe practices and subsequent escalation to an Immediate Threat to Health and Safety. For deemed organizations, CMS requires that state and accreditation organizations refer any infection control breaches that could potentially expose patients to the blood or bodily fluids of another to the appropriate state public health authority (S&C: 14-36-ALL REVISED 10.28.16). In July 2021, the Joint Commission will publish clarification on how compliance with reprocessing of ultrasound transducers will be scored. Prior topics include water management, personal protective equipment, surgical attire, and food and drink in patient care areas. IPs should review scoring examples to identify if interventions are needed to ensure patient safety.
• Ask a Standards question link. By accessing this link, IPs can ask a certified infection preventionist a question and have it answered. It will not result in notification of a surveyor or have any impact on the survey (other than helping clarify a requirement). IPs can ask for an email or a phone response. For complex questions, ask to schedule a phone call. If you feel that you need the answer in writing, ask if you can summarize the key points that you heard and send it to the to confirm or clarify the discussion.
Most IPs are responsible for ensuring organizational compliance to Joint Commission infection prevention and control standards. By following the aforementioned “tips” they can help ensure their healthcare organization is compliant with Joint Commission standards. The Joint Commission would love to hear from IPs. Submit suggestions for additional useful information, send feedback or ask a question though The Joint Commission’s “Ask a Standards Question” link.
Sylvia Garcia Houchins, MBA, RN, CIC, is the infection control and prevention director for the Joint Commission
Using a Post-Operative Surgical Site Infection Prevention Bundle to Reduce Risk
By Sue Barnes, RN, CIC, FAPIC
This column originally appeared in the May 2021 issue of Healthcare Hygiene magazine.
Guidelines addressing the prevention of surgical site infections (SSI), using a bundle of measures, include those from the Centers for Disease Control and Prevention,1 the American College of Surgeons,2 the World Health Organization3 as well as a nationally accepted protocol called Enhanced Recovery After Surgery (ERAS).4 Each of the SSI prevention guidelines focus on the pre-operative and intra-operative periods, with little or no information regarding the post-operative period.5 And while the ERAS protocol(s) does address the post-operative period, it does not address infection risk in that period. The surgical incision(s) does not begin to heal until 48 hours days post-op when epithelialization of the wound occurs, and until then it is possible for contamination to occur which can lead to infection.6
Wound Closure and SSI Risk
Wound closure is applied during the intraoperative period, but remains in place, and impacts incisional healing and the risk of post-operative SSI. There is wide variation in clinical guidance regarding wound closure and conclusive direction is missing from the current SSI prevention guidelines. Consequently, wound closure is primarily guided by surgeon choice. Wound closure types include non-impregnated suture, antimicrobial impregnated suture, staples, steri-strips, surgical glue (2-octyl-cyanoacrylate) and sometimes a combination of glue over suture or steri-strips. There is evidence that the following wound closure types can increase surgical infections risk: staples,7,8 non-impregnated suture.9 Alternatively, there is evidence that the following wound closure types reduce surgical infection risk: antimicrobial (triclosan) impregnated suture9, surgical glue (2-octyl-cyanoacrylate), or a combination of glue over suture.8
Post-Operative Wound Dressing and SSI Risk
Gauze and tape dressings, the original post-op dressing, were designed to protect the incision from disruption. During the past decade there have been numerous innovations in post-op incisional dressings. Today, these innovative dressings are designed to not only protect the incision, but also promote an optimal healing environment, and reduce the risk for microbial growth. And yet, arguable the most common type of post-operative dressing remains gauze and tape, because as with other post-op procedures, clear direction is missing from the SSI prevention guidelines. Consequently, dressing choice is based mostly on surgeon preference. Innovations in post-op dressings for which there is evidence of reduced infection risk include those that are absorbent, transparent and CHG-impregnated,10 silver-impregnated,11,12 and negative pressure wound dressings.13
Post-Operative Bathing and SSI Risk
Directions given to patients after surgery, commonly include a restriction from bathing for 48 to 72 hours, presumably to prevent irritating or macerating the wound, and disturbing the healing environment. However, there is no science supporting this restriction, and reducing hygiene may result in accumulation of sweat and dirt on the body, increasing the risk of wound contamination. Since clear direction regarding post-op bathing is missing from the SSI prevention guidelines, this is commonly left to the surgeons’ discretion. According to one clinical paper which reviewed nine studies involving 2,150 patients, no increased incidence of infection was found in the patients allowed to shower or bathe as a part of their normal daily hygiene before suture removal compared with those who were instructed to keep the site dry until suture removal.14 Given that all SSI prevention guidelines recommend bathing with chlorhexidine (CHG) soap or impregnated CHG wash cloths before surgery, some hospitals are reasonably concluding that post op bathing with CHG for a few days until the incision begins to heal, is prudent.15
Nasal Colonization and SSI Risk
Nasal decolonization has long been reported in peer reviewed studies as an important tool when used in a bundle, to reduce the risk of post-operative surgical site infections. However, the studies have all focused only on preoperative application of nasal decolonizing agents. This may be because most of the studies were performed using mupirocin which requires five consecutive days of application, and then provides Staph aureus elimination for up to 87 percent after four weeks, and 48 percent after six months.16 Now that nasal antiseptics are taking the place of mupirocin due to the immediacy of effect, as well as the emergence of mupirocin resistant Staph aureus, some hospitals are continuing the application of the alcohol-based nasal antiseptic for a few days until incisional healing begins.17
While a bundle approach to SSI prevention has been recommended by the existing clinical SSI prevention guidelines, none address the post-operative period of incisional healing. There is evidence to recommend at least four prevention measures that reduce the risk of SSI during the post-operative period:
1. Wound closure with antimicrobial impregnated suture, surgical glue, or a combination of the two
2. An innovative post-operative dressing supported by peer reviewed clinical evidence of efficacy
3. Bathing/showering post-operative days 1-4, with 4 percent CHG soap or 2 percent CHG-impregnated bathing cloths
4. Twice daily nasal decolonization with alcohol based nasal antiseptic post-operative days 1-4.
1. Anderson DJ, Podgorny K, Berríos-Torres SI, et al. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014;35(6):605-627. doi:10.1086/676022
2. Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017 Jan;224(1):59-74. doi: 10.1016/j.jamcollsurg.2016.10.029.
3. Global Guidelines for the Prevention of Surgical Site Infection. Geneva: World Health Organization; 2018. PMID: 30689333.
4. Pędziwiatr M, Mavrikis J, Witowski J, et al. Current status of enhanced recovery after surgery (ERAS) protocol in gastrointestinal surgery. Med Oncol. 2018;35(6):95. Published 2018 May 9. doi:10.1007/s12032-018-1153-0
5. Caruso TJ, Wang EY, Schwenk H, Marquez JLS, Cahn J, Loh L, Shaffer J, Chen K, Wood M, Sharek PJ. A Postoperative Care Bundle Reduces Surgical Site Infections in Pediatric Patients Undergoing Cardiac Surgeries. Jt Comm J Qual Patient Saf. 2019 Mar;45(3):156-163. doi: 10.1016/j.jcjq.2018.05.009.
6. Lawrence WT. Physiology of the acute wound. Clinics in Plastic Surgery 1998;25(3):321‐40.
7. Carli AV, Spiro S, Barlow BT, Haas SB. Using a non-invasive secure skin closure following total knee arthroplasty leads to fewer wound complications and no patient home care visits compared to surgical staples. Knee. 2017 Oct;24(5):1221-1226. doi: 10.1016/j.knee.2017.07.007.
8. Ando M, Tamaki T, Yoshida M, Sasaki S, Toge Y, Matsumoto T, Maio K, Sakata R, Fukui D, Kanno S, Nakagawa Y, Yamada H. Surgical site infection in spinal surgery: a comparative study between 2-octyl-cyanoacrylate and staples for wound closure. Eur Spine J. 2014 Apr;23(4):854-62. doi: 10.1007/s00586-014-3202-5.
9. Renko M, Paalanne N, Tapiainen T, Hinkkainen M, et al. Triclosan-containing sutures versus ordinary sutures for reducing surgical site infections in children: A double-blind, randomised controlled trial. Lancet Infect Dis. 2016 Sep 19. pii: S1473-3099(16)30373-5. doi: 10.1016/S1473- 3099(16)30373-5
10. Bashir, MH, Olson LK and Walters SA. (2012). Suppression of regrowth of normal skin flora under chlorhexidine gluconate dressings applied to chlorhexidine gluconate-prepped skin. Am J Infect Control, 40(4), 344-348. doi:10.1016/j.ajic.2011.03.030
11. Abboud, E. C., Settle, J. C., Legare, T. B., Marcet, J. E., Barillo, D. J., & Sanchez, J. E. (2014). Silver-based dressings for the reduction of surgical site infection: review of current experience and recommendation for future studies. Burns, 40 Suppl 1, S30-S39. doi:10.1016/j.burns.2014.09.011 25.
12. Connery SA, Downes KL and Young C. (2012). A retrospective study evaluating silver-impregnated dressings on cesarean wound healing. Adv Skin Wound Care, 25(9), 414-419.
13. Norman G, Goh EL, Dumville JC, et al. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2020;6(6):CD009261. Published 2020 Jun 15. doi:10.1002/14651858.CD009261.pub6
14. Dayton P, Feilmeier M, Sedberry S. Does postoperative showering or bathing of a surgical site increase the incidence of infection? A systematic review of the literature. J Foot Ankle Surg. 2013 Sep-Oct;52(5):612-4. doi: 10.1053/j.jfas.2013.02.016.
15. Children’s Mercy Post Op Bundle: https://www.childrensmercy.org/siteassets/media-documents-for-depts-section/documents-for-health-care-providers/evidence-based-practice/critically-appraised-topics/ssi-postoperative-surgery-bundle.pdf accessed April 21, 2021
16. Doebbeling BN, Breneman DL, Neu HC, Aly R, Yangco BG, Holley HP Jr, Marsh RJ, Pfaller MA, McGowan JE Jr, Scully BE. Elimination of Staphylococcus aureus nasal carriage in health care workers: analysis of six clinical trials with calcium mupirocin ointment. The Mupirocin Collaborative Study Group. Clin Infect Dis. 1993 Sep; 17(3):466-74.
17. Franklin S. A safer, less costly SSI prevention protocol-Universal versus targeted preoperative decolonization. Am J Infect Control. 2020 Dec;48(12):1501-1503. doi: 10.1016/j.ajic.2020.02.012.
Developing a Respiratory Protection Program
By Hillary Hei, MPH, CIC, LSSGB
This column originally appeared in the April 2021 issue of Healthcare Hygiene magazine.
The response to the COVID-19 pandemic has emphasized the need for adequate protection against SARS-CoV-2 to ensure employee safety. Prior to the pandemic, most healthcare settings outside of acute care rarely needed to wear respiratory protection beyond a medical-grade facemask. With this abrupt shift in the need for respirator use, many facilities using respirators for the first time also need to adhere to and maintain compliance with federal regulations. If respirators are used in a workplace, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) requires employers to follow the Respiratory Protection Standard 29 CFR 1910.134, or OSHA state-plan equivalent.1 This standard states that if staff must wear a respirator due to an identified hazard at work, a written respiratory protection program (RPP) is required.
From the start of the pandemic through Dec. 31, 2020, OSHA has issued numerous citations from more than 300 inspections for violations relating to COVID-19,2 identified either by complaints, referrals or severe incident reports. This has totaled more than $3.9 million in proposed penalties across many industries, with healthcare settings including hospitals, nursing homes, and long-term care settings.
Whether your facility is experienced with an RPP or not, it is best to ensure your program is in compliance with OSHA regulations and that the program can be sustainably maintained. OSHA’s Respiratory Protection standard 29 CFR 1910.134 has legally enforceable requirements when respirators are used, including:
- Designate a respirator program administrator (RPA).
Each facility must designate one individual to be like an air-traffic controller for the complete RPP. This person is in charge of setting up and overseeing the program, with specific tasks such as maintaining all necessary records and arranging annual trainings and fit tests. This person does not need to be a licensed healthcare professional but should be “qualified by appropriate training or experience1.”
- Develop a written workplace-specific RPP and update as necessary.
The facility’s RPP must be relevant and specific to the worksite. OSHA also emphasizes the need to keep the program updated as necessary. Anytime a policy or procedure related to respirator use changes, this must be reflected in the RPP.
- Complete a hazard assessment.
A hazard assessment is essential to identify potential hazardous exposures that require the use of respiratory protection while employees are on the job. It is important to consider all employee roles, duties, and responsibilities while performing this assessment.
- Select the respirators that will be used based on the hazard assessment.
In healthcare settings, potential exposures to infectious pathogens may warrant protection against droplet or airborne transmission. If respirators are needed to provide reduced exposure to airborne hazards, it’s important to specify in your RPP which type(s) of respirator the facility will use (e.g. N95s, elastomeric facemasks).
- Conduct medical evaluations.
Because respirator use may exacerbate underlying medical conditions, medical evaluations are required for each employee prior to donning a respirator for work or fit testing. Information solicited from evaluation questionnaires must be reviewed by a physician or other licensed healthcare professional, and the employee must be approved prior to using a respirator.
- Complete respirator fit testing.
Fit testing is the most important part of the respirator program, and OSHA requires fit testing for all users of tight-fitting respirators. The test ensures that the brand make and size adequately reduces employee exposure from airborne hazards. This fit test must be repeated annually, whenever the employee reports changes in their physical condition, or when a different brand, type, or size of respirator is introduced to the employee for use. Facilities can perform fit tests through either a qualitative or quantitative fit test.
- Educate employees.
Training is also essential, as staff must understand the limitations and capabilities of the respirator used. Users should know when a respirator is necessary, how to inspect, put on, and properly take off a respirator, and how to properly perform a seal check.
- Maintain all necessary records.
The RPP requires all records to be maintained and readily available to staff and OSHA upon request. Staff medical questions, medical evaluation and clearance, fit testing records, and documentation of staff training must be kept.
The response to the pandemic has created an increased demand for respirators such as N95s and has resulted in supply chain issues in respirators and fit testing kits. OSHA is temporarily exercising enforcement discretion on a case-by-case basis when considering issuing citations related to improper respiratory protection during COVID-19. Facilities must demonstrate and document “good-faith” efforts to comply with OSHA standards and any interim enforcement memoranda.3 Interim provisions with altered enforcement include postponing annual staff fit testing,4 the use of respirators beyond the manufacturer’s recommended shelf life,5 extended use and limited reuse, the utilization of respirators from other countries not approved by NIOSH,6 and decontamination for reuse.7
Under the Biden administration, employers should expect increased enforcement by OSHA. Effective March 12, 2021, OSHA is now implementing a National Emphasis Program to ensure that employees in high-hazard industries are protected from SARS-CoV-2 transmission.8 The new directive emphasizes more resources to provide on-site workplace inspections, targeting healthcare settings such as hospitals, nursing homes and assisted living, and emergency response settings. In order to be prepared, review or create your worksite-specific RPP, update and edit old procedures, and ensure staff are educated in proper respirator use to ensure employee safety.
If you are in a long-term care setting and would like to learn more, visit ECRI (https://www.ecri.org/solutions/respiratory-protection-program-ltc) for a comprehensive learning module that provides an in-depth foundation on establishing and sustaining your own RPP.
Hillary Hei, MPH, CIC, LSSGB, is an infection preventionist with ECRI, an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings worldwide.
- Standard 1910.134: Respiratory Protection. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134. Accessed March 22, 2021.
- OSHA National News Release. January 8, 2021. U.S. Department of Labor’s OSHA Announces $3,930,381 in Coronavirus Violations. https://www.osha.gov/news/newsreleases/national/01082021. Accessed March 22, 2021.
- OSHA Enforcement Memorandum. April 16, 2020. Discretion in Enforcement when Considering an Employer’s Good Faith Efforts During the Coronavirus Disease 2019 (COVID-19) Pandemic. https://www.osha.gov/memos/2020-04-16/discretion-enforcement-when-considering-employers-good-faith-efforts-during. Accessed March 22, 2021.
- OSHA Enforcement Memorandum. March 14, 2020. Temporary Enforcement Guidance – Healthcare Respiratory Protection Annual Fit-Testing for N95 Filtering Facepieces During the COVID-19 Outbreak. https://www.osha.gov/memos/2020-03-14/temporary-enforcement-guidance-healthcare-respiratory-protection-annual-fit. Accessed March 22, 2021.
- OSHA Enforcement Memorandum. April 8, 2020. Expanded Temporary Enforcement Guidance on Respiratory Protection Fit-Testing for N95 Filtering Facepieces in All Industries During the Coronavirus Disease 2019 (COVID-19) Pandemic. https://www.osha.gov/memos/2020-04-08/expanded-temporary-enforcement-guidance-respiratory-protection-fit-testing-n95. Accessed March 22, 2021.
- OSHA Enforcement Memorandum. April 3, 2020. Enforcement Guidance for Use of Respiratory Protection Equipment Certified under Standards of Other Countries or Jurisdictions During the Coronavirus Disease 2019 (COVID-19) Pandemic. https://www.osha.gov/memos/2020-04-03/enforcement-guidance-use-respiratory-protection-equipment-certified-under. Accessed March 22, 2021.
- OSHA Enforcement Memorandum. April 24, 2020. Enforcement Guidance on Decontamination of Filtering Facepiece Respirators in Healthcare During the Coronavirus Disease 2019 (COVID-19) Pandemic. https://www.osha.gov/memos/2020-04-24/enforcement-guidance-decontamination-filtering-facepiece-respirators-healthcare. Accessed March 22, 2021.
- OSHA Direction. March 12, 2021. National Emphasis Program – Coronavirus Diseases 20219 (COVID-19). https://www.osha.gov/sites/default/files/enforcement
Updating Standards to Improve Patient Safety: Water Management
By Sylvia Garcia-Houchins, MBA, RN, CIC
This column originally appeared in the March 2021 issue of Healthcare Hygiene magazine.
Even though the United States has one of the safest water systems in the world, the Centers for Disease Control and Prevention (CDC) has estimated that 7.2 million Americans get sick every year from diseases spread through water. Some of those illnesses occur while patients are receiving care within health care organizations. However, quantifying the actual number of those that occur within health care organizations is difficult. These illnesses may or may not be recognized as resulting from a water source and, even if recognized, still may not be reported to public health because the causative agent is not Legionella. Legionella is nationally reportable while other causative agents are not specifically required to be reported by certain State Health Departments. For example, Washington State has specific reporting requirements for waterborne outbreaks while other states have general requirements for reporting clusters or outbreaks that do not specify known or suspected waterborne disease.
Once reported, state and local health departments have jurisdiction over investigations within their state and may choose not to provide aggregated data on the results of those investigations. However, media reports periodically highlight outbreaks across the United States. When invited to assist with an outbreak investigation, the CDC Division of Healthcare Quality Promotion (DHQP) identified that 22 percent of consultations they conducted were water related. DHQP identified nontuberculous mycobacteria as the most frequently involved pathogen during their investigations (29.9 percent) but it identified an additional list of 20 organisms, including those that are frequently identified in clinical specimens such as Pseudomonas spp., Acinetobacter baumanii, and Enterobacter spp. The organization also found that the source of the outbreaks they investigated most often involved medical products (35.8 percent), and most of these products were medical devices (83.3 percent). DHQP findings emphasize the need to consider not only centralized water systems, but any devices that utilize water, as potential sources of waterborne disease. Patient waterborne infections identified by DHQP were determined to be preventable if the affected health care organization had utilized available information about prevention of waterborne pathogens and implemented an effective water management plan.
In 2017 (and updated in 2018), CMS published Requirement to Reduce Legionella Risk in Healthcare Facility Water Systems to Prevent Cases and Outbreaks of Legionnaires’ Disease. At that time, the Joint Commission did not make any changes to its standards as failure of hospitals, critical access hospitals, and nursing care centers to minimizes pathogenic biological agents in cooling towers, domestic hot- and cold-water systems, and other aerosolizing water systems was already being scored under standard EC.02.05.01 EP 14 (EP 6 for NCC).
Almost four years later, accredited organizations are still being cited out of compliance. And, more importantly, patients continue to develop preventable waterborne infections. There are a lot of reasons (e.g., more pressing priorities, lack of knowledge, misunderstanding of the requirements) for which organizations have not complied, developed, and implemented an effective water management program. As is the nation's oldest and largest standards-setting and accrediting body in healthcare, the Joint Commission has evaluated the situation and identified an opportunity ensure that organizations implement processes to reach zero harm from preventable waterborne disease. In its current form, EC.02.05.01 EP 14 (EP 6 in the Comprehensive Accreditation Manual for Nursing Care Centers) does not provide sufficient guidance and requirements to ensure organizations are implementing appropriate water management plans.
In October 2020, the Joint Commission published draft water management program standards for field review. Positive comments received verified some existing suspicions. The majority of responding healthcare organizations had a water management plan (90 percent) that addressed Legionella prevention but only 74 percent indicated that they addressed other waterborne pathogens. Based on feedback from field review and water experts at the CDC, the draft water management program standards were updated and approved by CMS, as required for deeming.
The new standard and EPs (EC.02.05.02, EPs 1 through 4) will be published July 1, 2021 in accreditation manuals for hospitals, critical access hospitals, and nursing care centers. This standard is effective January 1, 2022, giving organizations time to ensure that they have developed and implemented a fully compliant water management program. The new standard incorporates and clarifies expectations currently addressed during the survey process. It also includes additional steps and processes such as assigning responsibility and oversight for the water management program, and identifying water sources, treatment systems, and types of water containing equipment using a basic diagram. Prepublication access will be available in April.
Examples of possible situations relating to EC.02.05.01 EP 14 that would currently be scored as non-compliant were published in the January 2020 edition of Perspectives. These examples remain applicable even with implementation of the new standard – although scoring location could change.
Organizations should be aware of free, available CDC resources that can be used to assist them in identifying risks and prevention strategies, including general information, organism-specific information, and tools for investigating outbreaks.
The resources discuss:
• Creating a comprehensive water management program, including a water risk assessment and basic prevention measures to prevent waterborne disease including a water management checklist for healthcare facilities
• Guidance for identifying specific problem organisms
o Nontuberculous mycobacteria
o Pseudomonas aeruginosa
• Managing Outbreak
Most healthcare organizations have been aware of the need to identify potential sources and control infection from Legionella. Now it is time to look into risks related to other waterborne pathogens that may be “flying under the radar” and causing disease to facilities’ patients. By using the excellent resources that CDC has developed, proactively identifying potential sources within a healthcare organization, and implementing surveillance and control measures, waterborne pathogens can be prevented, detected and controlled.
Sylvia Garcia-Houchins is the infection control and prevention director at the Joint Commission.
Reference: 1. Perkins, K., Reddy, S., Fagan, R., Arduino, M., & Perz, J. (2019). Investigation of healthcare infection risks from water-related organisms: Summary of CDC consultations, 2014—2017. Infection Control & Hospital Epidemiology, 40(6), 621-626. doi:10.1017/ice.2019.60
Infection Prevention, Patient Safety and Quality – Which Came First?
By Sue Barnes, RN, CIC, FAPIC
Editor's note: This column originally appeared in the February 2021 issue of Healthcare Hygiene magazine.
The departments of patient safety, quality and infection prevention and control (IP&C) all support optimizing of healthcare outcomes and are driven by state and federal regulatory requirements. Safety departments aim to prevent or reduce patient injury and harm. Quality departments aim to increase the use of and adherence to evidence-based practices and to improve efficiency.1 IP&C is separate from, but supportive of, the objectives of both patient quality and patient safety by reducing the risk and rate of healthcare associated infections and controlling outbreaks of infectious disease.2 IP&C is a scientific field of clinical practice which is grounded in infectious diseases, epidemiology, and health systems science.
Which Came First?
The concept of infection prevention and control came first and can be traced back to the work of Ignaz Semmelweis, an obstetrician in the 1800s who championed the importance of handwashing to prevent puerperal (childbirth) fever and the associated high incidence of mortality. Unfortunately, as history asserts, Semmelweis was ridiculed and his germ theory was dismissed.3 The current-day profession of IP&C is instead based on the work of 19th century scientists such as Pasteur, Lister and Koch, and was recognized as a specialty almost a century later in the 1970s. In its early decades, the evolving specialty was led by registered nurses who still remain the single largest group of clinicians within the profession.4 Once assumed to be inevitable, clinical research in the area of healthcare-associated infections (HAIs) has proven that a significant percentage are preventable.
One of the first studies to prove this was the CDC’s Study on the Efficacy of Nosocomial Infection Control (SENIC) published in 1985 which estimated that 30 percent to 50 percent of HAIs are preventable with effective infection surveillance and control programs.5 Over the last 50 years, IP&C has evolved and expanded to become a rigorous, complex and essential clinical profession, often not understood by hospital administrators who tend to position these professionals subordinately to the non-clinical departments of quality or patient safety. In hospitals where they report directly to the C-suite (chief executive officer, chief medical officer, etc.), they are afforded the support and authority to execute their programs expediently, thereby reducing patient morbidity and mortality.6 When this is not the case, there is often associated under-market compensation, which in addition to the increasing incidence of retiring experienced IP&C professionals, and the ever increasing burden of data reporting, is resulting in an ongoing exodus of IP&C professionals nationwide.4 In response, the field of IP&C has opened its doors to individuals with public health and laboratory science backgrounds. However, there is no replacement for the registered nurse who has the training and knowledge of the clinical pathophysiology of infection and the physiological details that reveal the dynamic causes of sentinel HAI and outbreaks.7
The concept of quality improvement in healthcare was introduced in the early 1900s by Ernest Codman, a surgeon who first pioneered the creation of hospital standards and strategies to assess healthcare outcomes. The modern quality movement has since transformed to include creating practice guidelines in addition to ongoing comprehensive assessment of hospitals and healthcare providers.8 The current day hospital quality departments are typically well-resourced and well-positioned, often reporting directly to the C-suite.9
The concept of patient safety in healthcare was sparked in the late 1990s, with publication of the Institute of Medicine (IOM) report, “To Err is Human.” This report estimated that as many as 98,000 patients die from preventable errors in U.S. hospitals annually, a statistic which immediately garnered public and legislative attention.10 Local and national efforts subsequently began to focus on categories of preventable error such as pressure ulcers, patient falls and medication administration errors. This also rapidly led to development of new patient safety certifications, courses and positions in healthcare. This department is typically now well-resourced and positioned, often reporting directly to the C-suite.11
The departments of quality, patient safety and IP&C all support the overarching goal of optimizing patient outcomes in healthcare. Quality and patient safety use social theories to address improvement in a broad range of areas such as physician competence, medication administration, patient falls and pressure ulcer prevention. Infection prevention is a clinical science-based profession which stands parallel but equal to these non-clinical departments. Organizational charts should reflect (at a minimum) equivalence in authority for the three departments to ensure optimally expeditious interventions for reduction of patient morbidity and mortality associated with HAIs.
1. Johns Hopkins Medicine Armstrong Institute: https://www.hopkinsmedicine.org/armstrong_institute/_files/patient%20safety%20and%20quality%20improvement%20project%20tools/spirit_toolkit/the_differences_and_similarities_between_patient_safety_quality_improvement.pdf accessed January 14, 2021.
2. World Health Organization: https://www.who.int/gpsc/ipc/en/ accessed January 14, 2021.
3. Marjoua Y, Bozic KJ. Brief history of quality movement in U.S. healthcare. Curr Rev Musculoskelet Med. 2012;5(4):265-273. doi:10.1007/s12178-012-9137-8.
4. Hanchett M. The Infection Control Nurse: Approaching the End of an Era. Infection Control Today. Aug. 31, 2015.https://www.infectioncontroltoday.com/view/infection-control-nurse-approaching-end-era
5. Hughes JM. Study on the efficacy of nosocomial infection control (SENIC Project): results and implications for the future. Chemotherapy. 1988;34(6):553-61. doi: 10.1159/000238624. PMID: 3243099.
6. Barnes S, Spencer M. Reliable Design of IP Programs. Infection Control Today. Sept. 11, 2015.
7. Cox JL, Simpson MD. Microbiology Education and Infection Control Competency: Offering a New Perspective. J Microbiol Biol Educ. 2018;19(2):19.2.71. June 29, 2018. doi:10.1128/jmbe.v19i2.1475.
8. Luce JM, Bindman AB, Lee PR. A brief history of health care quality assessment and improvement in the United States. West J Med. 1994 Mar;160(3):263-8. PMID: 8191769; PMCID: PMC1022402.
9. Salary.com https://www.salary.com/research/job-description/benchmark/quality-management-director-healthcare-job-description#:~:text=Being%20a%20Quality%20Management%20Director,Typically%20reports%20to%20top%20management.
10. Lark ME, Kirkpatrick K, Chung KC. Patient Safety Movement: History and Future Directions. J Hand Surg Am. 2018;43(2):174-178. doi:10.1016/j.jhsa.2017.11.006
11. Institute for Healthcare Improvement: http://www.ihi.org/resources/Pages/Changes/DesignateaPatientSafetyOfficer.aspx
Sharps Injuries in 2020: The Year to Learn from the Past, Draw from the Present, and Improve the Future of Worker Safety in Healthcare
By Amber Hogan Mitchell, DrPH, MPH, CPH
This column originally appeared in the January 2021 issue of Healthcare Hygiene magazine.
Reprinted with permission from ORsafe.org
November 2020 marked 20 years since the passage of the Needlestick Safety and Prevention Act (NSPA). The Act required the Occupational Safety and Health Administration (OSHA) to update its 1991 Bloodborne Pathogens Standard to include new protections for workers facing exposures to blood, body fluids, and other potentially infectious materials.
At the time, advocates for worker health and safety and preventing sharps injuries and needlesticks were so aligned that champions from multiple disciplines and backgrounds came together seamlessly to fight for stricter policies that addressed safer conditions in healthcare. The Act was passed unanimously by Congress Nov. 6, 2020. Clinicians affected by injuries, worker safety and health advocates, manufacturers, unions, law makers, and regulators came together to improve the coverage the standard offered to workers.
At a high level, this meant inclusion of more specific requirements for:
- The evaluation and use of engineering controls, including safer medical devices like needleless systems and “sharps with engineered sharps injury protections” (devices with sharps injury prevention features).
- The inclusion of frontline non-managerial employees in the identification, evaluation, and selection of engineering controls and work practices.
- Establishing and maintaining a sharps injury log (beyond what is required by the OSHA Recordkeeping Rule).
On a more facility-specific level, this meant then and still means now that employers – despite being faced with competing safety and quality initiatives -- do not lose sight of identifying where injuries are occurring, during what procedures, and with what devices or practices. This includes using the Sharps Injury Log as an evergreen tool to direct campaigns and controls that prevent future injuries and learn from past ones.
Over the 20 years when incident data is compared at the facility-level to the national or regional levels, data tracks true to bigger surveillance systems that collect and report sharps injuries to the public, including the Exposure Prevention Information Network (EPINet®) from the International Safety Center and the Sharps Injury Surveillance System (SISS) from the Massachusetts Department of Public Health (MA DPH). As a nation, we saw great strides for decreasing incidence of injuries from blood collection devices, IV catheters, and lancets. Technologies got better, safer and more intuitive and the tide changed for the benefit of exposure prevention.
Today, however, reported incidents of injuries from hypodermic syringes, suture needles, and scalpel blades continue to be unacceptably high. In fact, according to both EPINet and MA SISS, these three device categories represent the highest numbers of injuries compared to all other device types in recent reporting years. They remain the devices that need greater attention relative to identifying and selecting better, safer alternatives and effective work practice controls like “safety” feature activation, no hands passing, and safe disposal.
Key Questions Looking Forward
In 2021, will we see percentages of device types change because of the pandemic? If we don’t manage the delivery of SARS-CoV-2 vaccines using devices with sharps injury prevention features will we see a drastic increase of injuries from hypodermic needles?
How might these reported incidents change in a pandemic age where there is more focus on keeping adequate stock of personal protective equipment like respirators and less on engineering controls for sharps injury prevention?
Given overcrowding and careful management of capacity available for patients suffering with COVID-19 or flu and protecting workers from airborne infectious disease, might focus on preventing exposures to bloodborne pathogens falter?
Given more focus than ever on worker health and safety in healthcare due to the global pandemic are we at continued risk of compromising worker safety for patient safety or will the tide change? Will we continue to sacrifice, overwork, and under-resource our healthcare workforce or will the pandemic improve conditions?
Yes, it has been 20 years since the passage of the NSPA and we celebrate that momentous occasion and yes, we are working through a global pandemic and we hope to see the light at the end of the tunnel in the coming months. 2020 has been wrought with ups and downs, challenges and opportunities, successes and failures and we must use what we have learned to make healthcare better and safer for those who work in it and those who access it.
Focus on COVID must not mean that we lose focus on sharps injuries that we can see and know how to prevent. Focus on PPE to prevent infectious disease exposures must not mean that we ignore what we know about the industrial hygiene hierarchy of controls and lose focus on the effectiveness of engineering controls and safe work practices. These include not only the use of devices with sharps injury prevention features like retracting needles and blades and suture-alternatives for skin closure, but safety feature activation, and responsible and safe disposal. This also includes shining a light on facilities, advocates, and manufacturers that get it right, work together, stay the course, and collaborate on developing and using the best devices to ensure the highest quality outcomes for workers and patients alike.
Amber Hogan Mitchell, DrPH, MPH, CPH, is currently president and executive director of the International Safety Center as well as the immediate past chair of the Occupational Health and Safety section of the American Public Health Association (APHA). Mitchell's career has been focused on public health and occupational safety and health related to preventing infectious disease. She is also a senior science adviser for the NIEHS Worker Training Program for COVID-19 response. Mitchell holds an adjunct faculty position at the University of Maryland School of Medicine Department of Environmental and Occupational Medicine. Mitchell has a new book available called Preventing Occupational Exposure to Infectious Disease in Health Care: A Practical Guide.
Herd Immunity and COVID-19
By Sue Barnes, RN, CIC, FAPIC
This column originally appeared in the December 2020 issue of Healthcare Hygiene magazine.
When a large percentage of a community is immune to an infectious disease, ongoing transmission of the disease is unlikely. This state is termed herd immunity, and it can be achieved through vaccination (vaccine induced immunity) and through infection with the disease (natural immunity). It is important to note that by reducing viral transmission, herd immunity provides protection to those who cannot be vaccinated such as newborns, and immunocompromised individuals.1
The number of people required to be immune to achieve herd immunity is based on the contagiousness of the disease. Those infectious diseases that spread easily, such as measles, require a higher number of immune individuals in a community to reach herd immunity. COVID-19 is also a very contagious disease. Experts estimate that in the United States, more than 200 million people (70 percent of the population) would have to recover from COVID-19 and develop effective natural immunity in order to achieve herd immunity, thereby halting the epidemic.2
There are a lot of unknowns with COVID-19 which add complications to the goal of achieving herd immunity. Most importantly we do not have a vaccine and may not for some time. Additionally, we do not know if immunity is always conferred by COVID-19 infection, nor which people develop natural immunity after infection, and how long immunity might last. Even once a vaccine is developed, there are variables that will impact its effect on the pandemic. These include how effective the vaccine is, how many vaccine doses will be available for distribution, and how many people are willing to get vaccinated. This last variable is anticipated to be a significant challenge given the number of people who refuse to receive the annual influenza vaccination. And of course, even with a vaccine, until herd immunity is achieved, cases introduced by those traveling from outside of the U.S. will contribute to the ongoing US COVID-19 epidemic.3
Given the lack of a unified national response to the COVID-19 pandemic in the U.S., a wide spectrum of approaches can be seen relative to prevention tactics from state to state. This has also resulted in the highest case and death count globally, and dissent among various experts regarding the best method of achieving herd immunity.4 On the one hand, there is the Great Barrington Declaration. This is a statement written by three public health experts, which supports achieving herd immunity by allowing COVID-19 to spread in the young and healthy population where it is less likely to be deadly. The three experts suggest that the current COVID-19 prevention measures are resulting in greater harms than the pandemic, including economic instability, lower childhood vaccination rates, fewer health screenings, and deteriorating mental health.5
This Declaration was denounced by the John Snow Memorandum, which was published in response and signed by 6,900 scientists and health experts.6 The memorandum recommends that restrictions (not lock down) should be continued, in addition to social and economic programs and vaccine development. These experts explain that the primary concern with permitting spread of COVID-19 is that it would lead to the death of one to two million people, without necessarily speeding up society’s return to business as usual. In addition, if so many people become sick with COVID-19 at one time, hospitals would become quickly overwhelmed.
Many medical professionals use the term “herd protection” instead of herd immunity, because the phenomenon doesn’t actually result in immunity to the virus. Instead it reduces the risk that non-immune people will come into contact with the virus. Applying the concept of herd immunity through community spread of SARS CoV2, would be based on the unproven assumption that anyone who survives an infection will become immune. From studies of the pandemic to date, it does seem that some kind of immunity seems to follow infection, but it is unclear how long and for which people this occurs. And we don’t yet have a definitive method to measure immunity to SARS CoV2 virus.7
In the absence of a national approach to the pandemic, it may be prudent to look to the clinical professionals for guidance (John Snow Memorandum), versus those in public health sector (the Barrington Declaration) if the two are not in alignment. Clinical experts not only have training and experience regarding infectious diseases they are also at the front lines, observing first-hand what is happening with the pandemic. As concluded by the John Snow Memorandum, herd immunity for COVID-19 cannot safely be achieved with natural immunity alone but must be supplemented with vaccine induced immunity once an effective vaccine is widely available. In the meantime, local governments will continue to determine what restrictions on business are needed, supplementing social distancing and mask/face coverings, to contain the pandemic.
1. CDC. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm Last accessed November 3, 2020.
2. Mayo. https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/herd-immunity-and-coronavirus/art-20486808 Accessed Nov, 3, 2020.
3. The Lancet. https://doi.org/10.1016/S0140-6736(20)32153-x Accessed Nov. 3, 2020.
4. Altman D. Understanding the US failure on coronavirus. BMJ 2020; 370:m3417. DOI: https://doi.org/10.1136/bmj.m3417 (Published Sept. 14, 2020).
5. Great Barrington Declaration. https://gbdeclaration.org/ Accessed Nov, 3, 2020.
6. John Snow Memorandum. https://www.johnsnowmemo.com/ Accessed Nov. 3, 2020.
7. Aschwanden C. The false promise of herd immunity for COVID-19. Nature online; Oct. 21, 2020. DOI: https://doi.org/10.1038/d41586-020-02948-4 Accessed Nov. 3, 2020.
COVID-19 Lessons Learned at Nine Months
By Phenelle Segal, RN, CIC, FAPIC
Editor's note: This column originally appeared in the November 2020 issue of Healthcare Hygiene magazine.
November 2020 signifies an unprecedented nine months into the COVID-19 pandemic that took the nation by surprise and resulted in a tragedy on many levels. The intensity and speed with which this virus entered the United States turned healthcare facilities upside down across the continuum of care. Acute care hospitals were unprepared with inadequate supplies of personal protective equipment (PPE), disinfectants and equipment, thereby creating challenges of unprecedented proportions. Hospital beds were filling at alarming rates and several hospitals were turning non-clinical areas into wards or units. Makeshift hospitals were being erected in some cities and staff shortages were extreme.
Long-term care and outpatient facilities including doctor’s offices and clinics were unable to obtain supplies due to demand outweighing supply and this resulted in a state of chaos. Nursing homes and other long-term care settings in many regions were hit very hard with facility outbreaks and many elderly residents died. Lack of preparation was not necessarily the fault of the individual facilities or offices and practices, but rather, akin to the “big earthquake.” Unpredictable until it happens and particularly with such intensity.
Well into the pandemic, due to the diligence of the healthcare industry, Food and Drug Administration (FDA), Environmental Protection Agency (EPA) the Occupational Safety and Health Administration (OSHA) and private organizations as well as supply companies, obstacles have been approached aggressively. Depending on the location of facilities and the number of COVID-19 cases, supplies including personal protective equipment or PPE have become more available, albeit an ongoing shortage of N95 masks for some acute care and non-acute care settings. Many facilities have been able to revert to conventional capacity as per the Centers for Disease Control and Prevention (CDC) guidance developed earlier in the pandemic for optimizing PPE. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html.
A critical component of the ability to respond to large-scale disasters is surge capacity. Surge capacity is defined as “a healthcare system’s ability to expand quickly beyond normal services to meet an increased demand for medical care” or “ the ability to expand care capabilities in response to sudden or more prolonged demand.”
Emergency preparedness and planning in response to the terrorist attack on 9/11 was ramped up and beginning in 2003, The Joint Commission required all acute-care hospitals to develop a written plan based on facility hazard vulnerability assessments. In 2004, The Agency for Healthcare Research and Quality (AHRQ) expanded its Bioterrorism Planning and Response research and focused on ways to expand bed capacity in hospitals and develop surge requirements. In addition, in 2008 the U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) were included in the emphasis on emergency preparedness and planning, with the Department of Homeland Security funding initiatives.
Effective emergency preparedness in healthcare requires planning for large-scale situations that affect many people. These events include terrorist attacks resulting in multi-casualty trauma, chemical, biological and radioactive events. Infectious disease epidemics and pandemics between 2003 and prior to COVID-19 included severe acute respiratory syndrome (SARS), Middle Eastern Respiratory Syndrome (MERS), H1N1 flu and Ebola virus. Each event includes subtle differences in the type of capacity needed, but general principles apply.
For at least two decades, hospitals have provided a written plan evaluating their hazard risks, resources, and an idea of their general ability to handle a surge including highly transmissible infectious agents. Prior to COVID-19, long-term care facilities (LTCFs) which includes nursing homes, assisted living facilities, and rehabilitation centers were expected to address surge capacity for the purpose of being available either for acute-care patients or for patients who were discharged early from traditional acute-care facilities to make beds available for additional acute care victims needing hospitalization.
Nursing homes had plans in place for some public health emergencies, but many had not done planning specific to pandemics such as COVID-19. Natural disaster plans were available such as those for wildfires and earthquakes. Planning was also depended on facility location and state requirements.
In planning for emergencies, concerns in nursing homes included caring for special patient populations during an emergency. Concerns about staffing in an emergency were seen across the board and staff were reluctant to leave their families. Lack of adequate amounts of medications and medical supplies as well as storage space for such were of concern too. Many nursing homes across the nation were willing to accept residents from area hospitals but concerns regarding the patient acuity levels and subsequent staffing and building capacity issues were of concern.
Key Components of Surge Capacity
The key components of surge capacity are known as “4 S’s” and include Staff, Stuff, Structure and Systems.
Key personnel include clinical staff such as physicians, nurses, respiratory therapists, pharmacists and technicians. Support staff such as environmental services, physical plant services, security services and clerical workers are indispensable during a pandemic. Intensive care units and emergency departments are two areas that require a tremendous number of staff. Repurposing of staff may be required including retired clinical personnel or those with expired professional licenses.
Staff shortages due to long shifts and physical exhaustion, PPE burnout due to mandatory use, emotional burnout, resignations, inability to work due to childcare or elder care needs and ill personnel with several deaths are expected.
Surge capacity stuff includes durable equipment such as ventilators, oxygen masks, oximeters, defibrillators, intravenous (IV) pumps, blood glucose and INR monitors, cardiac monitors, hospital beds and wheelchairs. In addition, patient supplies include medications, IV catheters and fluids, oxygen, syringes, sutures, sterile dressings and PPE. Shortages are expected when a pandemic of epic proportions takes over a nation and unanticipated supplies are needed.
Hospitals will need to be reconfigured including utilizing rooms that are not typically patient care rooms, converting positive into negative pressure rooms, use of the operating rooms with anesthesia machines for critical patients and rearranging the emergency department. Outpatient clinics could be used as a satellite emergency department. Designating COVID-19 units and COVID-free units is essential. Staff should be dedicated to both. During epic pandemics, these needs will most likely be impossible to fulfill, especially at the beginning of the wave.
Systems include a clear chain of command for different activities. This chain of command should have a commander available day and night and be a good communicator with an effective communication strategy inside and outside the facility. The ability to share information among staff, the media, patients or residents and families is essential. Systems include written policies, procedures and protocols as well as education of personnel. Systems also include designating personnel to be responsible for “stuff” including PPE and reporting issues to the chain of command.
COVID-19 challenges during the past nine months have forever changed the focus of emergency planning. Surge capacity and planning for future disasters will require ongoing dedication and determination across the continuum of healthcare. The combination of tremendous teamwork, flexibility, creativity and coping skills inherent in healthcare professionals is evident several months into the disaster and as we prepare for the “winter wave” combined with influenza, facilities including acute, long-term and outpatient care are ready to: face existing and new challenges with strength and determination.
Phenelle Segal, RN, CIC, FAPIC, is president of Infection Control Consulting Services.
1. Surge Capacity: Disaster Medicine. 2006: 193–202. Published online 2009 May15. doi: 10.1016/B978-0-323-03253-7.50035-2
2. Exploring the Concept of Surge Capacity" OJIN: The Online Journal of Issues in Nursing; Vol. 14 No.2. DOI: 10.3912/OJIN.Vol14No02PPT03
3. How to Surge to Face the SARS-CoV-2 Outbreak: Lessons learned from Lombardy, Italy. Disaster Med Public Health Prep 2020 Apr 1: 1-3. doi: 10.1017/dmp.2020.64
Leading the Way to Zero: Integrating What We’ve Learned to Create the “New Normal”
By Sylvia Garcia, MBA, RN, CIC
Editor's note: This column originally appeared in the October 2020 issue of Healthcare Hygiene magazine.
On Sept. 14, 2020, The Institute for Healthcare Improvement’s National Steering Committee for Patient Safety released Safer Together: A National Action Plan to Advance Patient Safety. This plan emphasizes that “…safety requires a shift from reactive, piecemeal interventions to a proactive strategy in which risks are anticipated and system-wide safety processes are established and applied…”
Anticipating risks and implementing safety processes are an infection preventionist’s “bread and butter.” We are trained to systematically apply models to explain and prevent transmission of infections within our organizations. The chain of infection is one model and another is the Hierarchy of Controls. The chain of infection identifies the route of transmission as the weakest link in the chain. If we can break that link, we can prevent transmission. n the Hierarchy of Controls, the most effective methods are at the top: elimination and substitution, and the least effective methods are at the bottom: administrative controls and personal protective equipment. Using what was known about COVID-19 transmission, initial reaction to COVID-19 focused on an integrated response to prevent transmission of COVID-19 which strived to:
• Eliminate the hazard and conserve resources by stopping elective procedures and limiting or barring visitors
• Substitute processes such as telehealth to provide care
• Install engineering control such as physical barriers at reception points
• Implement administrative controls such as screening everyone entering the facility for symptoms
• Provide personal protective equipment (PPE) to our frontline workers.
As cases increased around the world and transmission from asymptomatic cases was identified, organizations adjusted their approaches. Many people started to wear face masks and respirators out in public and in healthcare settings causing confusion and controversy. With dire PPE shortages in some parts of the United States, public officials emphasized that medical face masks and respirators should be reserved as PPE for those providing care to patients. In an effort to conserve scarce resources, some organizations restricted use of medical and surgical masks and respirators to those providing direct care to patients with known or suspected COVID-19.
Face coverings (masks made of cloth) were suggested as an alternative that would conserve resources for frontline workers. Initial information indicated that face coverings would not protect the wearer but could protect others. Now, increasing evidence concludes that universal masking and use of face coverings can protect the wearer and others from COVID-19.
The effect of COVID-19 prevention methods on influenza in the southern hemisphere countries offers hope for a controlled influenza season. Data on influenza from Australia, Chile, and South Africa shows very low influenza activity during June thru August 2020, the months that reflect typical Southern Hemisphere influenza season. Summer circulation of influenza in the United States is at a historical low.
There is no “magic bullet” that, by itself, will prevent transmission of respiratory viruses, including COVID-19 and influenza. Historically, we have focused on respiratory etiquette - encouraging patients to cover their cough and when possible wear a mask if they have respiratory symptoms. Despite improving influenza vaccination rates and implementation of respiratory etiquette, health care organizations have continued to identify health care associated transmission to patients and staff. As we move into the “new normal” of COVID-19 and face the start of influenza season, we need to use information we have learned from our experiences with COVID-19 to protect our patients, visitors, and staff. The CDC estimates that 3 to 8 percent of the U.S. population contracts influenza each year. Like COVID-19, influenza is transmissible before symptoms develop.
With information evolving on the role of microdroplets and ventilation, specifically air exchanges, in transmission of COVID-19, health care organizations need to plan for the coming winter. Rigorous implementation of COVID-19 prevention strategies including universal masking, social distancing, hand hygiene and surface disinfection can control COVID-19. When paired with influenza vaccination, these strategies may also lead to an influenza season with low transmission and provide information that could lead to new proactive strategies to prevent transmission respiratory viruses.
Infection preventionists must be able to integrate evolving information to make convincing recommendations for prevention to their leadership teams. Although work on the National Action Plan began before COVID-19, its release is timely as the core principles and recommendations are extremely relevant to the pandemic. Ultimately, the decision on which prevention strategies to implement and when they should be implemented is in the collective hands of health care organizational leaders. Even with state mandates, health care organizations can choose to rigorously educate and enforce implementation, or they can, instead, put up signs and call it a day. Ideally, it is the hope of infection preventionists, like me, that healthcare organizations will lead the way to zero harm by using the valuable information we are learning during this pandemic.
Sylvia Garcia, MBA, RN, CIC, is director of infection prevention and control within the of Division of Healthcare Improvement at the Joint Commission.
1. National Steering Committee for Patient Safety. Safer Together: A National Action Plan to Advance Patient Safety. Boston, Massachusetts: Institute for Healthcare Improvement; 2020. Available at: www.ihi.org/SafetyActionPlan
2. Centers for Disease Control and Prevention. Principles of Epidemiology in Public Health Practice, Third Edition. Available at https://www.cdc.gov/csels/dsepd/ss1978/index.html Accessed September 29, 2020.
3. Centers for Disease Control and Prevention. National Institute for Occupational Safety and Health. Workplace Safety and Health Topics. Hierarchy of Controls. Available at https://www.cdc.gov/niosh/topics/hierarchy/default.html Accessed September 28, 2020
4. Occupational Safety and Health. Recommended Practices for Safety and Health Programs. Hazard Prevention and Control. Available at https://www.osha.gov/shpguidelines/hazard-prevention.html Accessed September 28, 2020.
5. Wang X, Ferro EG, Zhou G, Hashimoto D, Bhatt DL. Association between universal masking in a health care system and SARS-CoV-2 positivity among health care workers. JAMA. Published online July 14, 2020. doi:10.1001/jama.2020.12897
6. Hendrix MJ, Walde C, Findley K, Trotman R. Absence of Apparent Transmission of SARS-CoV-2 from Two Stylists After Exposure at a Hair Salon with a Universal Face Covering Policy - Springfield, Missouri, May 2020. MMWR Morb Mortal Wkly Rep 2020;69:930-932. DOI:http://dx.doi.org/10.15585/mmwr.mm6928e2external icon
7. Olsen SJ, Azziz-Baumgartner E, Budd AP, et al. Decreased Influenza Activity During the COVID-19 Pandemic — United States, Australia, Chile, and South Africa, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1305–1309. DOI: http://dx.doi.org/10.15585/mmwr.mm6937a6
8. Centers for Disease Control and Prevention. Key Facts About Influenza (Flu) Available at https://www.cdc.gov/flu/about/keyfacts.htm Accessed on September 29, 2020.9. Centers for Disease Control and Prevention. How Flu Spreads. Available at https://www.cdc.gov/flu/about/disease/spread.htm#:~:text=When%20Flu%20Spreads,7%20days%20after%20becoming%20sick. Accessed September 29, 2020.
Beyond Bundles: Resources to Support IP Departments During the Pandemic
By Sue Barnes, RN, CIC, FAPIC
This column originally appeared in the September 2020 issue of Healthcare Hygiene magazine.
During the current COVID-19 pandemic, infection prevention department (IPD) resources have been dramatically impacted by efforts required for containment of the virus. There is, consequently, less focus on prevention of healthcare-associated infections (HAIs). This diversion of focus is creating risk for patients according to clinicians at the Virginia Commonwealth University Health System. Their Twitter survey in April revealed that the majority of more than 200 respondents reported that the pandemic was consuming 75 percent of IPD time and resources.1
The report from the authors of a recent clinical paper makes similar observations, based on the experience of several of the hospitals in New York and Missouri.2 They suggest that the COVID-19 pandemic will significantly impact the rate of central line-associated bloodstream infections (CLABSIs), which have been observed to increase more than 300 percent in two hospitals over the past 15 months. The authors theorize that this may be due to smaller denominators as a result of fewer elective procedures, decreases in hospital census, as well as an increase in high-risk patients. In addition, proning critically ill COVID-19 patients could potentially cause disruption of central-line dressings.2 Also adding to the risk in some locations, intravenous (IV) tubing is being extended so that IV pumps can be kept outside of patient rooms. This creates the potential risk of contamination of tubing when in contact with floors.3
This is truly concerning, given that even prior to the pandemic, zero preventable HAI had not been achieved and/or sustained in many U.S. healthcare facilities.4 In most hospitals, a bundle of standard measures (i.e., supported by category 1 level evidence, defined as at least one properly designed randomized controlled trial) is the first line approach for prevention of all categories of HAI. When zero preventable infections are not achieved with a bundle of standard measures, one or more plus measures are often added (defined as supported by less than category 1 level evidence such as cohort or case control studies and expert opinion). For example, a standard bundle measure for prevention of surgical site infections (SSIs) is controlling serum glucose. An example of a plus measure for prevention of SSIs is pre-operative nasal decolonization. The number and type of plus measures is dynamic and always changing as studies are completed on emerging technologies and evidence is made available. Keeping pace with this dynamic body of knowledge is time-consuming. Consequently, in one large multi-hospital system, the national infection prevention program leader developed a Beyond Bundles Plus Measures HAI Prevention Toolkit to help the organization’s infection prevention staff keep pace with the constantly evolving infection prevention measures (products and practices) and associated evidence of efficacy.
Beyond Bundles Plus Measures HAI Prevention Toolkit
This 48-page document includes evidence summaries for all products and practices included, and is updated every two years. It is organized in chapters by infection type as follows: CAUTI (catheter associated urinary tract infection), CDI (Clostridium difficile infection), CRBSI (catheter related bloodstream infection which includes prevention of both CLABSI and peripheral bloodstream infections), HAP (non-ventilator associated hospital acquired pneumonia), MDRO (multi-drug resistant organism infections), VAP (ventilator associated pneumonia) and SSI. Each chapter begins with a list of standard bundle measures. Following the standard measures in each chapter, a table lists the plus measures designed to prevent that particular type of HAI. The plus measures are identified during deep review of clinical journals, attendance of professional conferences, continuing education courses, and networking with clinical experts and industry partners by the author. The collection is not intended to be exhaustive, as it is limited by the author’s due diligence in the collection and review of this clinical information. Vendors have been invited to share evidence, and product names are included when evidence of efficacy has been made available. So, although the toolkit includes product names, it does not seek to promote any product or company.
Following each plus measure there is an embedded document containing an evidence summary, which is also updated every two years. Product order information is provided in the form of links and text, as well as tools supporting implementation of the product or practice, such as video clips and embedded checklists and guidelines. The toolkit is available for download in full, and also by individual chapter, in open-access format and has been publicized widely including via social media. https://www.zeroinfections.org/toolkits.html
Especially today, when faced with the COVID-19 pandemic, infection preventionists are challenged with competing priorities. This open-access toolkit, offers a no cost aid for IP departments which supports the resource intensive task of reviewing the emerging evidence of efficacy associated with plus infection prevention measures. Unless zero preventable infections have been achieved with standard bundle measures, this is an essential task in optimizing infection prevention programs.
1. Stevens M, Doll M, Pryor R, Godbout E, Cooper K and Bearman G. Impact of COVID-19 on traditional healthcare-associated infection prevention efforts. Infect Control Hosp Epidemiol. 41(8), 946-947. 2020. doi:10.1017/ice.2020.141
2. McMullen KM, Smith BA, Rebmann T. Impact of SARS-CoV-2 on hospital-acquired infection rates in the United States: Predictions and early results. July 2, 2020. Am J Infect Control. 2020; S0196-6553(20)30634-9. doi:10.1016/j.ajic.2020.06.209
3. Institute for Safe Medication Practices: https://ismp.org/resources/clinical-experiences-keeping-infusion-pumps-outside-room-covid-19-patients
4. CDC HAI Progress Report: https://www.cdc.gov/hai/data/portal/progress-report.html
Navigating COVID-19’s Ongoing Challenges: A Perspective From the Front Lines of Infection Prevention
By Phenelle Segal RN, CIC, FAPIC
This column originally appeared in the August 2020 issue of Healthcare Hygiene magazine.
In a pre-COVID 19 world, August is the height of summer vacation for millions of Americans. People enjoy backyard barbecues, swimming parties, fun at the beach, traveling and organizing family reunions as the nation enjoys a much-needed reprieve from cold temperatures and long work hours. The summer of 2020 is very different as it continues to reveal a tumultuous and unprecedented pandemic. COVID-19 continues to follow the trajectory of an out of control respiratory-spread virus, that has the power to sicken and kill many Americans within a short period of time. Besides the tragic toll on human lives, COVID-19 continues to affect the economy and threatens healthcare facilities and workers with no end in sight. The ongoing challenges we face is evident including severe shortages of personal protective equipment (PPE) and disinfectant products among many others.
Ongoing Challenges in Healthcare Facilities
Over the course of five months, infection preventionists -- after planning and preparing as best as possible -- were unaware of the impact an out-of-control, highly transmissible respiratory virus could have on a system-wide basis. Prior pandemics including SARS, H1N1, MERS and Ebola revealed the need to stay on top of surge capacity plans in the event of a “COVID-19 catastrophe. However, in line with other natural disasters, we had no idea when it would strike, what type of disease would attack and how much of an impact it would have. We were always aware that our efforts to plan for the “big one,” may fall short of the needs as the unknown would deliver its punches. Decades of developing, implementing, and educating on “best practices” have abruptly halted as infection preventionists and healthcare educators scramble to prioritize and use best judgment, while guiding facilities across the continuum of care. The frustration in having to let go of routine practices is daunting, but infection preventionists must be flexible in an ever-changing environment. This article will address two ongoing critical challenges as we continue striving in a nontraditional fashion to strive for staff and patient safety.
Personal Protective Equipment (PPE) Shortage
Filtering face-piece respirators (FFRs) including but not limited to N95 respirator masks are critical items in the prevention of COVID-19 spread and other aerosol transmissible diseases. They remain in ongoing short supply throughout the nation. FFRs protect the user by filtering particles out of the air that is being breathed by the users. The National Institute for Occupational Safety and Health (NIOSH) the federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness has seven classes of FFRs approved with a ninety-five percent minimum level of filtration (95 percent). Masks that filter less than 95 percent of particles are not guaranteed to be as effective as those that filter 95 percent or more. NIOSH works in conjunction with the Occupational Health and Safety (OSHA) agency that regulates respiratory programs for healthcare workers.
N95 masks are the traditional FFR used in hospitals for healthcare personnel taking care of patients requiring airborne isolation. The most common use has been for patients with aerosol transmissible diseases including pulmonary tuberculosis (TB). They are manufactured and sold as “single use only” and until COVID-19, there was no shortage of these items.
In response to the increased demand for use as thousands of cases were occurring in the hot zones in March and April, the Food and Drug Administration (FDA) released Emergency Use Authorizations (EUAs) for companies that had developed a “mask reprocessing” system to decontaminate N95s for reuse. Only N95 masks can be decontaminated but is dependent on the manufacturer and products used. Some N95 masks are not compatible with reprocessing such as those made with cellulose. In addition, the Centers for Disease Control and Prevention (CDC) issued guidance for reuse and extended use of single use FFRs. To date, facilities are reprocessing N95 masks via authorized methods and strictly follow the manufacturer of the mask as well as the decontamination equipment’s instructions for use. These methods are primarily using hydrogen peroxide in various forms, but with limited numbers of reprocessing cycles (based on the type of equipment) before having to discard them.
Infection preventionists continue to work with facilities that cannot reprocess masks and one of the CDC recommendations for extending the “life of the mask” is to place them in a brown paper bag or other breathable container for at least 72 hours before wearing them again. Facilities are providing a limited number of N95 masks to employees at most risk. That includes healthcare workers caring directly for COVID-19 positive and those providing aerosol generating procedures (AGPs) such as anesthesiology personnel. Staff are wearing surgical masks over their N95 masks to prevent them from becoming decontaminated. Face shields are thought to provide some protection from becoming contaminated too. Reuse and disinfection techniques are neither simple, nor ideal, but at this juncture, the choices are limited. It is important to note that masks must be discarded if they are visibly soiled, damaged or become moist/wet as they will not function effectively.
OSHA (29 CFR 1910.134) requires a medical evaluation, fit-testing and training prior to use of N95 masks performed initially (before the employee is required to wear the N95) followed by annual fit testing prior to COVID-19. However, OSHA did provide Temporary Enforcement Guidance in response to COVID-19 and despite the temporary guidance, challenges with lack of availability of appropriate sizes for staff members and short supply of solution for the fit test kits continues. A self-administered seal check should be performed before donning the masks.
Additional FFRs have been authorized by NIOSH for use including but not limited to “Surgical N95 respirators” and Powered Air Purifying Respirators (PAPRs). PAPRs do not have to be fit tested. Lastly, hospitals have turned to reusable elastomeric non-powered air-purifying half facepiece (half mask) manufactured to be reused, which has distinct advantages. They also need a fit test prior to first use.
Disinfectant Product Shortage
Coronaviruses are enveloped viruses and hence are extremely easy to kill using the appropriate disinfectant. Novel coronaviruses are unable to achieve a viral claim in a short amount of time and usually companies take a year or more to complete testing. Due to the length of time it takes to achieve this claim, the U.S. developed a policy based on a hierarchy for companies, meaning that if a product is effective against “harder to kill viruses, it is likely to kill COVID-19”. Harder to kill viruses include the non-enveloped group including norovirus, poliovirus, rhinorvirus, feline and reovirus.
Shortly after the pandemic was recognized as a potential threat as well as the emphasis placed on the size of COVID-19 droplets and the ability to settle on surfaces, disinfectant products became difficult to obtain as the demand outweighed the supply. This included online and in-store purchases as well as manufacturers and distributors running out of product. In response to the importance of surface disinfection and product shortages, the Environmental Protection Agency (EPA) developed an extensive list of products shortly after COVID-19 was exponentially spreading. Known as the EPA’s “List N: Disinfectants for Use Against SARS-CoV-2 (COVID-19), it is constantly updated, and new products are being added. Facilities are encouraged to check the list regularly. https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2-covid-19
Hospitals continue to face shortages of disinfectant wipes and liquid with no immediate “return to normal” for availability of supplies. Manufacturers are developing creative strategies to provide product to healthcare facilities as a priority. The public has very limited access to supplies on shelves, with a one per person limit in most stores. Online purchase of products are prioritized for healthcare facilities only and the public does not have access to them.
Extreme shortages are occurring in non-acute care-based healthcare facilities at a higher rate than acute care hospitals. The primary reason in the non-hospital- based facilities is due to the product manufacturers prioritizing distribution based on previous use. Acute care hospitals use disinfectants on a much larger scale than non-acute based facilities. Manufacturers are reviewing order history together with supply when determining which facilities receive products and the quantity allocated.
Five months into the pandemic, with record numbers of cases appearing in many states and no end in sight, infection prevention challenges will continue to arise. It is incumbent upon us as healthcare providers, to face these hard times with strength, skill and perseverance as we continue to work at providing the support, strength and structure to our colleagues and patients.
Phenelle Segal, RN, CIC, FAPIC, is president of Infection Control Consulting Services.
Under-Addressed Risk Factors for COVID-19 and Future Pandemics
By Sue Barnes, RN, CIC, FAPIC
This column originally appeared in the July 2020 issue of Healthcare Hygiene magazine.
We have learned much about critical risks factors that lead to global transmission of novel respiratory viruses, including the current COVID-19 pandemic as well as those in the past. This must in turn, inform our preparedness for future pandemics. The risk factors include a lack of herd immunity for novel viruses, inadequate/untimely transnational communication and collaboration when novel virus is first identified, inadequate stores of personal protective equipment, viral qualities such contagiousness and modes of transmission (e.g., coughing, sneezing, face touching, and contact with contaminated surfaces). Especially during the current pandemic, there is tremendous focus placed on mitigation strategies for each of these risk factors. However, there are two additional risk factors which have received less attention during the current and past pandemics. These are: 1) the infection transmission risk posed by pre-school and school-aged children and 2) the risk posed by Asian mixed wild animal wet markets, both in introducing novel viruses as well as transmitting them.
The Role of Pre-School and School-Aged Children
Young children often play a significant role in transmission of respiratory viruses including pandemic influenza (flu) and the current novel coronavirus SARS CoV2 which causes COVID-19 infections.1 Given that respiratory viruses are found in the nose and throat, and children frequently touch their noses, eyes and mouths, share objects that have been put in their mouths, and have physical contact during play, these viruses are easily transmitted among children and with parents, teachers and caregivers. Transmission then continues with contacts of the parents, teachers and caregivers. Exacerbating the current pandemic is the lack of immunity to this novel virus in both adults and children. And even with seasonal flu, young children may not have pre-existing herd immunity.2
Containing the transmission of pandemic flu and other respiratory viruses including SARS CoV2, posed by young children within our global population, will require ongoing education of children, parents and caregivers. The education must include information and training regarding hand hygiene, face coverings, environmental disinfection and physical distancing. It must also include sufficient sourcing of supplies (e.g. masks/face coverings, hand sanitizer, environmental disinfectant) to ensure that these are ubiquitous. Adequate annual influenza vaccination of all three groups, children, parents, and teachers will continue to be critical, in addition to SARS CoV2/COVID-19 vaccination when it becomes available. Nasal antiseptics as part of daily hygiene for children, teachers and caregivers would be arguably an added advantage providing an extra layer of safety. This type of product has been used successfully in healthcare to reduce infections by bacteria residing in the nose.3 Studies are needed to determine if nasal antiseptics can similarly reduce the risk of respiratory viral infections as well, but it is a good bet since respiratory virus is more easily inactivated than bacteria.4 Temperature screening, mask wearing for middle school, and physical distancing strategies, such as smaller class sizes, with rotation of students between in person classrooms and distance learning strategies may also be important in reducing the contribution of respiratory viral transmission by young children.5 Read more here:6 https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/schools.html
The Role of Live Animal Wet Markets in Asia
Asian wet markets where live animals are sold have been proposed or confirmed as the source of a number of pandemics including Asian Flu 1957, Hong Kong Flu 1968, SARS CoV1 2003 and SARS CoV2 2019.7 These markets create a perfect environment for the introduction and transmission of novel viral pathogens, where wild animals of many types from all over the world are brought into close contact which would never happen in the natural world.
The animals in the market are packed together for days and sometimes longer and are often slaughtered in the market where blood and body fluids are generated, and many humans are gathered. This is where viral pathogens can be transmitted between species and then to humans. This is especially true mainland China where the markets have many kinds of animals – some wild, some domesticated and not always native. These animals are stressed in crowded captivity among humans resulting in reducing their natural immunity and facilitating viral transmission, and with genetic mixing, novel viral strains. There are many types of wet markets in Asia, only the type described posing the greatest risk. There also many challenges to reducing or eliminating them including culture and tradition.8 Read more at: https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/schools.html
The elimination of all wet markets would not be a practical or reasonable approach, which would be like prohibiting all farmers markets in the U.S. However, reducing or eliminating live animal wet markets in mainland China should be considered, given the morbidity and mortality resulting from the pandemics which continue to be generated from such markets.9-11
Sue Barnes, RN, CIC, FAPIC is an independent clinical consultant, Board certified in Infection Control and Prevention, a Fellow of APIC (FAPIC) and co-founder of the National Corporate IP Director Network. She currently provides marketing and clinical consultation to select industry partners who seek to support infection prevention with innovative products.
1. Mimura S, Kamigaki T, Takahashi Y, Umenai T, Kudou M, Oshitani H. Role of Preschool and Primary School Children in Epidemics of Influenza A in a Local Community in Japan during Two Consecutive Seasons with A(H3N2) as a Predominant Subtype. PLoS One. 2015;10(5):e0125642. Published 2015 May 5. doi:10.1371/journal.pone.0125642
2. Miller E, Hoschler K, Hardelid P, Stanford E, Andrews N, Zambon M. Incidence of 2009 pandemic influenza A H1N1 infection in England: a cross-sectional serological study. Lancet. 2010 Mar 27; 375(9720):1100-8. doi:10.1016/S0140-6736(09)62126-7.
3. Mullen A et al. Perioperative participation of orthopedic patients and surgical staff in a nasal decolonization intervention to reduce Staphylococcus spp surgical site infections. American Journal of Infection Control. 45 (2017) 554-6.
4. Osborne K. Viruses, bacteria and fungi. Virox animal health online. October 31, 2017. https://www.viroxanimalhealth.com/blog/viruses-and-bacteria-and-fungi-oh-mydont-let-vicious-viruses-beastly-bacteria-or-freaky-fungi-haunt-you accessed June 13, 2020.
5. United Nations Educational, Scientific and Cultural Organization (UNESCO) https://en.unesco.org/news/back-school-preparing-and-managing-reopening-schools accessed June 13, 2020.
6. CDC Considerations for Schools https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/schools.html accessed June 13, 2020.
7. Webster RG. Wet markets--a continuing source of severe acute respiratory syndrome and influenza? Lancet. 2004;363(9404):234‐236. doi:10.1016/S0140-6736(03)15329-9.
8. Woo PC, Lau SK, Yuen KY. Infectious diseases emerging from Chinese wet-markets: zoonotic origins of severe respiratory viral infections. Curr Opin Infect Dis. 2006;19(5):401‐407. doi:10.1097/01.qco.0000244043.08264.fc.
9. Beaubien J. Why They're Called 'Wet Markets' — And What Health Risks They Might Pose. January 31, 2020. NPR online https://www.npr.org/sections/goatsandsoda/2020/01/31/800975655/why-theyre-called-wet-markets-and-what-health-risks-they-might-pose accessed June 13, 2020.
10. Kawaoka Y, Krauss S, Webster RG. Avian-to-human transmission of the PB1 gene of influenza A viruses in the 1957 and 1968 pandemics. J Virol. 1989 Nov; 63(11):4603-8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC251093/ accessed June 13, 2020.
Infection Prevention Guidance for the Hotel Industry During COVID-19
By Carol McLay, DrPH, MPH, RN, CIC, FAPIC
This column originally appeared in the June 2020 issue of Healthcare Hygiene magazine.
The current COVID-19 outbreak is placing unique psychological stress points on the nation’s healthcare workers (HCWs). Previous research has shown that epidemics can cause severe psychological effects. A recent review of the mental health problems faced by HCWs during this pandemic suggests that HCWs are experiencing considerable stress, anxiety, depression and insomnia.1
Reasons for these adverse psychological outcomes range from excessive workload and work hours, making difficult decisions about how to conserve limited personal protective equipment (PPE) and prioritize treatment, anxiety over putting their families at risk for exposure to the virus, and confronting a mounting death rate.
With their extended work hours and close contact with COVID-19 patients, health care workers have expressed anxiety about safe accommodations. Some workers have long commutes and need a place close by to rest and regenerate. Many worry that they may expose their families to the virus when they return home.
Temporary housing options help to support the mental health needs of staff. Healthcare facilities are creating partnerships with local hotels, universities and rental properties to offer accommodation to healthcare workers.
Hotel rooms for healthcare workers are provided at no-cost through the Rooms for Responders program offered by Marriott Bonvoy, in collaboration with American Express and JPMorgan Chase.2 Hilton and American Express are donating up to 1 million hotel rooms to individual front-line medical professionals during the COVID-19 crisis.3
The American Hotel & Lodging Association (AHLA) has developed the “Hospitality for Hope Initiative” to enhance collaboration between the hotel industry and the health care community, first responders, and local communities.4 As part of the initiative, AHLA is working closely with the Department of Health and Human Services (HHS) to create a national database of hotel properties willing to provide temporary housing for emergency and healthcare workers. At the time of writing, more than 17,000 properties have agreed to participate, offering 2.3 million rooms to our healthcare heroes.
In preparation for hosting HCWs, hotel managers and staff should take precautions to improve guest and employee health and safety.
General guidelines include:
- Follow local/state public health recommendations
- Reinforce personal hygiene throughout your hotel
- Place signage and floor markers in lobby, elevator landings, restaurant areas and other communal areas displaying appropriate physical distancing and health and hygiene reminders.
- Provide hygiene materials such as hand sanitizer in strategic locations such as entrances, elevator landings, fitness centers, restaurants, ice and vending machines.
- Utilize disinfectants that are effective against SARS-CoV-2, the virus that causes COVID-19. (See the EPA’s List N: Disinfectants for Use Against SARS-CoV-2 for a list of approved disinfectants, at:https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2)
- Post a list of precautions that your property will be taking to ensure that both guests and employees will remain safe during this period.
- Consider housing HCWs on a separate wing or section of the hotel reserved for this workforce
Specific Guidelines for Procedural Implementation
• Consider requiring employees to wear a mask in public areas at all times.
• Consider screening all employees upon arrival to work. Screening questions include:
1. Do you have any flu-like symptoms such as fever, cough or shortness of breath?
2. Have you been around anyone that is positive for COVID-19?
If an employee answers yes to any of the above, have them return home and call their healthcare provider.
• Employees must sanitize hands upon entry of hotel and frequently during their shift.
• Provide employee education about COVID-19 fundamentals such as signs and symptoms, mode of transmission, and prevention strategies to reduce spread including importance of hand hygiene.
• Ensure communications are culturally and linguistically appropriate.
• Train staff to use disinfectants safely and correctly. Staff should wear gloves when cleaning. Follow the manufacturer’s recommendations for proper use of disinfectants; for example, if the product has a 30-second contact time, this means that surfaces must stay wet for 30 seconds to be effective.
• Clearly communicate leave policies for planned and unplanned absences; provide guidance and support for childcare and elder care.
• Implement policies to reduce the frequency and type of face-to-face contact among employees (e.g., hand shaking, shared work areas, break room); ensure employees maintain 6 feet of distance between other employees and guests.
• Closely monitor employee health. Reinforce personal hygiene and cough etiquette.
• Provide hand sanitizer stations and tissues to all employees and guests.
• Consider requiring all guests to wear a mask in public areas at all times.
• Encourage guests to sanitize hands on entry to hotel.
• No self-service, front desk staff to provide coffee/tea service upon request.
• Request that all guests exit room while room is being cleaned.
• Thoroughly clean and disinfect all hard surfaces, pay particular attention to high touch surfaces (see section below on specific touch surfaces).
• Do not reuse cleaning clothes between rooms, use disposable cloths/wipes if possible
• Remove bed scarves from service.
• Wash bedspreads/comforters between each guest.
• Remove minibar snacks and beverages from guest rooms, have available upon request.
• Clean and disinfect public restrooms on a frequent basis.
• Use disposable wipes if possible.
• Restrict access to ensure social distancing.
• Disinfect after each use, including wiping of keyboard and other high touch surfaces.
• Follow local guidance and adhere to strict physical distancing and sanitation protocols.
• Ensure guests have access to disinfection wipes.
• Frequent disinfection.
Public laundry facility
• Restrict access to one guest/family at a time.
• Disinfect laundry room after each use.
• Linen may become contaminated with the virus. Employees should handle contaminated linen as little as possible with minimal agitation.
• Wash items in accordance with the manufacturer’s instructions using the hottest appropriate water setting; dry items completely.
• Ensure disinfectant is added to laundry wash.
• Clean and disinfect hampers or other carts for transporting laundry.
• Follow local/state/federal regulations.
• Provide Grab and Go or pre-wrapped options.
• No self-service food/beverage stations.
• Update floor plans to allow for table configurations no less than 6 feet in proximity to other tables.
Specific Touch Points
Lobby and common areas
• Check-in desk
• Door handles, push plates, hand railings
• Telephone and keypad
• Tables and chairs
• Trash receptacle touch points
• Elevator buttons
• Door handles
• Sink faucets and toilet handles
• Soap dispenser handle
• Towel dispenser
• Baby changing station
• Trash receptacle touch points
• Door handles
• Desk, tables, chair, lamps
• Dresser drawer handle
• Drapery pull handles
• Mini-bar, menu, coffee maker
• Light switches and thermometers
• Telephone and keypad, remote control, and alarm clock
• Make up mirror, hand dryer
• Trash receptacle touch points
• Handles to clothes cupboard, hangers, luggage rack
• Frequent disinfection of door handles, keypads, buttons
It is critical to ensure the health and safety of this essential workforce and the hotel industry is uniquely positioned to support our HCWs who are on the frontlines of this public health crisis. Providing a safe, clean and comfortable hotel room to our exhausted workers after another grueling shift provides much needed physical and psychological support and safety. In addition, this provides hotels a means to keep their doors open and give back during this time of crisis.
By supporting and addressing the social needs of the healthcare workforce, hospitals continue to show their commitment and dedication to keeping Americans safe and healthy.
Carol McLay, DrPH, MPH, RN, CIC, FAPIC, is the CEO of Infection Control International and is a consultant in the fields of healthcare epidemiology, infection prevention and control, and public health.
1. Spoorthy M.S, Pratapa SK and Mahant, S. (2020). Mental health problems faced by healthcare workers due to the COVID-19 pandemic-A review. Asian Journal of Psychiatry. 51, 102119. Advance online publication: https://doi.org/10.1016/j.ajp.2020.102119
2. Rooms for Responders. Available at: https://marriottcares.marriott.com
3. Hilton and American Express Program. Available at: https://newsroom.hilton.com/corporate/news/hilton-american-express-team-up-to-donate-rooms
4. Hospitality for Hope. Available at: https://www.ahla.com/ahlas-hospitality-hope-initiative
COVID-19: The Journey From Mitigation to the ‘New Normal’
By Phenelle Segal, RN, CIC, FAPIC
Editor's note: This column originally appeared in the May 2020 issue of Healthcare Hygiene magazine.
In early January, clinicians in the United States were alerted to cases of a respiratory illness occurring since late December 2019 in dozens of patients from Wuhan, China. Clinicians were told to closely evaluate patients with symptoms and a history of recent travel to and from the affected area. On Jan. 21, 2020 the Centers for Disease Control and Prevention (CDC) officially confirmed the first case of a novel coronavirus in the state of Washington; the patient had returned from Wuhan on Jan. 15 and presented to a medical facility there. Due to his history of travel and respiratory symptoms, a new coronavirus illness was suspected, and a Real time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) test was run and confirmed the medical center’s suspicion. Within a month from first hearing about the initial cases, the world began experiencing the unprecedent 2019 Novel Coronavirus (2019-nCoV) pandemic.
When first identified in Wuhan, the virus was thought to spread from animal to humans, with no evidence that it was spreading from human to human. Like previous coronavirus organisms, COVID-19 appeared to originate in a poultry and seafood market during the latter part of 2019. The source was unclear with bats and pangolins highly suspected. Upon reaching the U.S., it was becoming more evident that person-to-person spread was a concern in China, but its rate and ability to spread remained unclear.
Healthcare facilities, particularly acute-care hospitals were overrun by sick patients, many of them requiring intensive care treatment with or without the use of a ventilator. Very ill patients have had a prolonged clinical course and delayed discharge due to an unprecedented list of clinical conditions. The huge influx of patients resulted in a tremendous shortage of personal protective equipment (PPE) and ventilators. The shortages were dependent on the region and directly proportional to the number of cases. After several weeks of frenzied care provided to hundreds of thousands of ill patients, many healthcare workers were and continue to be stricken with COVID-19 and several deaths have occurred.
Initial Mitigation Steps
Since CDC first heard of a surge in cases in Wuhan, the agency began preparing as best as possible, aware of the fact that it was a matter of time before the U.S. would see an influx. In conjunction with the White House, the following steps were taken and several remain in place to date:
• Developed an alert system for healthcare providers from the beginning of January.
• Provided guidance to clinicians about signs and symptoms as they were identified from Wuhan, and requesting they be alert for a positive travel history to and from potentially infected countries.
• Provided viral testing guidance.
• Provided preliminarily guidance for the care of patients in the home who may develop COVID-19.
• Provided guidance for airport screening of passengers coming into several major international airports.
• Assisted with developing a diagnostic test to detect this virus in clinical specimens.
• Activated its Emergency Operations Center to prepare for future support to healthcare providers.
• Deployed a team to Washington state to begin contract tracing and other support.
• Ordered each state to issue executive orders to shut down non-essential businesses, public gatherings, sports events, entertainment and stay at home orders.
• Ordered outpatient healthcare providers to cease providing non-urgent/non-emergent services including elective surgeries.
• Implemented social distancing strategies to curb the spread from close contact.
• Banned hospitals and nursing homes from visitors.
• Issued guidance for healthcare facility employees, vendors and essential persons to universally mask while in the building.
• Suggested individual states and counties implement face coverings for the general public.
• Guidance was and continues to be released at an accelerated rate for the community and healthcare industry.
• Ongoing updates from many sources were and continue to be very helpful in developing plans for healthcare facilities.
• CDC deployed additional personnel to “hot zones”.
• Conference calls for healthcare providers and community were set up and continue to take place.
• Guidance provided for agencies and companies developing additional tests including antibody tests.
• Guidance for companies and agencies reviewing and trialing medications to treat ill patients.
• Providing input for agencies and companies researching vaccine development.
Returning to the New Normal
Three months into the pandemic, the White House has introduced guidelines to reopen the country using a three-phased approach. Besides other industries, the first and second phase includes resuming outpatient and inpatient elective surgery respectively. Visitor bans will continue to be strictly upheld during phase one and for the most part phase two for hospitals and nursing homes. Every state will need to develop “reopening plans,” which is expected to be extremely challenging and will require a multi-disciplinary team approach.
Outpatient surgery centers are closed to elective procedures with urgent or emergent procedures allowed at the discretion of the medical providers. Elective procedures are on hold in hospitals too. During the ban of elective procedures, staff were responsible for developing initial plans for screening patients and physical distancing protocols. In addition, outpatient centers were asked to develop plans for possible conversion to COVID-19 bed use and anesthesia machines for the purpose of ventilating patients. PPE was to be preserved and in certain regions, sent to hospitals for front line staff to use during care of infected patients.
Roadmap for Resuming Elective Surgery After COVID-19 Pandemic
In late April, a joint statement was released by the American College of Surgeons, American Society of Anesthesiologists, Association of periOperative Registered Nurses and the American Hospital Association. The following is a list to guide surgery centers and hospitals for resuming procedures :
• Timing for Reopening of Elective Surgery – Reopening should be considered only after a sustained reduction in the rate of new COVID-19 cases in the relevant geographic area for at least 14 days.
• COVID-19 Testing within a Facility – Facilities should use available testing to protect staff and patient safety whenever possible and should implement a policy addressing requirements and frequency for patient and staff testing.
• Personal Protective Equipment – Facilities should not resume elective surgical procedures until they have adequate PPE and medical/surgical supplies appropriate to the number and type of procedures to be performed.
• Case Prioritization and Scheduling – Facilities should establish a prioritization policy committee consisting of surgery, anesthesia and nursing leadership to develop a prioritization strategy appropriate to the immediate patient needs.
• Post-COVID-19 Issues for the Five Phases of Surgical Care – Facilities should adopt policies addressing care issues specific to postponement of surgical scheduling related to COVID-19
• Collection and Management of Data – Facilities should reevaluate and reassess policies and procedures frequently, based on COVID-19 related data, resources, testing and other clinical information.
• COVID-related Safety and Risk Mitigation surrounding Second Wave – Facilities should have and implement a social distancing policy for staff, patients and patient visitors in non-restricted areas in the facility which meets then-current local and national recommendations for community isolation practices.
• Additional COVID-19 Related Issues including:
Healthcare worker well-being: post-traumatic stress, work hours.
Patient messaging and communication.
Case scheduling process.
Facility and OR/procedural safety for patients.
Preoperative testing process for COVID-19-positive and non-COVID-19-positive patients.
Prior to implementing the start-up of any invasive procedure, all areas should be terminally
cleaned according to evidence-based information.
In all areas along five phases of care (e.g. clinic, preoperative and OR/procedural areas,
workrooms, pathology-frozen, recovery room, patient areas, ICU, ventilators, scopes,
sterile processing, etc.)
Regulatory issues (The Joint Commission, CMS, CDC).
Operating/procedural rooms must meet engineering and Facility Guideline Institute standards for air exchanges.
Re-engineering, testing, and cleaning
Pandemics are like natural disasters; their timing and magnitude is unpredictable. COVID-19 arrived precipitously, spread rapidly and quickly overwhelmed the nation. History has proven that respiratory viruses don’t disappear and often linger for a few years or an effective vaccine is developed. H1N1 in 2009 lingered for approximately three years. A vaccine was developed and was introduced as a component of the annual flu. COVID-19 vaccine development has begun, but the outcomes remain unknown at this juncture.
The “new normal” is beginning to take shape. Facilities across the continuum of care are working through the challenges of realigning compromised infection prevention “best practices. Patient safety and prevention of transmission of hospital-acquired conditions, while temporarily disrupted, remains unchanged. Healthcare professionals have spent decades improving hand hygiene, disinfecting the environment, appropriate isolation of potentially transmissible patients and more. These “best practices” will require reeducation and training sooner than later as healthcare services resume.
Phenelle Segal, RN, CIC, FAPIC, is president of Infection Control Consulting Services.
The Role of Infection Preventionists in Antibiotic Stewardship Programs
By Sue Barnes, RN, CIC, FAPIC
This column originally appeared in the April 2020 issue of Healthcare Hygiene magazine.
Since their introduction in the 1940s, antibiotics have greatly reduced illness and death from all types of infections caused by bacteria. However, overuse has led to development of bacterial resistance, making the drugs less effective and creating bacteria that is more difficult to treat. Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics, and 23,000 people die as a direct result of these infections.1 To promote the appropriate use of antibiotics, antibiotic/antimicrobial stewardship programs (ASP) have been implemented in hospitals nationwide, and are required by the Joint Commission and the Centers for Medicare and Medicaid.2 These programs are making progress in reducing resistance, and the incidence of infections caused by multidrug-resistant organisms. In addition, the appropriate use of antibiotics also serves to reduce the incidence of Clostridium difficile infections (C. diff), caused in part by the disruption of helpful intestinal bacteria.1
Various perspectives have been offered regarding the role of the infection preventionist (IP) in ASP. A 2019 paper published in AJIC on the subject suggests that “the absence of a clear role definition for IPs in ASPs is likely hindering IPs from contributing in consistent, meaningful ways.”3 This was written subsequent to publication of two key Association for Professionals in Infection Control and Epidemiology (APIC) documents, suggesting that there is still work to do to clarify the role of the IP in ASP. The updated APIC-Society for Healthcare Epidemiology of America (SHEA) position paper on the role of the IP in ASP, published in 2018, proposes the following ASP related functions for IPs: 4
1. Leadership commitment: Infection prevention and control (IPC) and antimicrobial stewardship (AS) program leaders must work together to align their programs, promoting communication and collaboration, and reducing the likelihood of redundant initiatives.
2. Action: IPs can leverage strong collegial relationships to influence and facilitate nursing’s supporting role in initiating antibiotic timeouts, performing antibiotic reconciliation during patient transitions of care, and educating patients and families.
3. Tracking: IPC programs perform surveillance for emerging pathogens and resistance patterns, as well as rapid response to every possible transmission.
4. Reporting: IPC programs are responsible for HAI surveillance and providing feedback of infection rates (e.g., multidrug-resistant organisms and Clostridioides difficile/CDI) and audit data (e.g., hand hygiene adherence) to clinicians and other stakeholders. CDI prevention is a high priority for IPC and AS programs, so sharing and disseminating antibiotic use and CDI infection rates is essential to prevention efforts.
5. Education: Some specific examples include providing education to frontline healthcare workers regarding the appropriate collection of urine cultures, cultures from endotracheal tubes, and indications for testing for CDI infections.
6. Diagnosis: It is essential for IPs, HEs, and the AS team to understand the scope of rapid diagnostic tests and work together to assist clinicians in interpreting and responding appropriately to results.
The second APIC paper published in 2019 was “Advancing the profession: An updated future-oriented competency model for professional development in infection prevention and control,” proposed the following actions for the IP role in ASP:5
1. providing consultative expertise
2. being a leader and advocate
3. identifying and detecting multidrug-resistant organisms
4. reporting surveillance trends over time
5. using surveillance data (e.g., treating asymptomatic bacteriuria, collecting contaminated specimens)
6. analyzing antibiograms and antibiotic use
7. assisting with early organism and infected patient identification
8. promoting compliance with standard and transmission-based precautions and other infection prevention strategies, such as care bundle practices and hand hygiene
9. developing and providing educational programs for staff, patients, and visitors
Other experts have recommended additional activities which arguably would cross the boundary into the competencies of other departments. For instance, participating in the production of the antibiogram as well as providing associated training, would seem to cross the boundary into responsibilities/competencies of the laboratory scientist.6,7 Also suggested to be within the purview of the IP is identifying bug-drug mismatches (i.e., whether a prescribed antibiotic is effective based on bacterial sensitivities). This would seem more within the purview of the pharmacist and physician.7-9
Not mentioned in any of these papers is arguably the most significant role for IPs in antibiotic stewardship programs – the prevention of healthcare-associated infections (HAIs). For every infection prevented, there are fewer antibiotics administered in addition to the associated resistance pressure, CDI risk, incidence, associated patient morbidity and healthcare cost. The APIC publications provide a high-level overview of the role of the IP in ASP, which can be built upon at the local level to provide more specific actions. Ongoing updates will be required moving forward due to the dynamic nature of the responsibilities of the IP.
Sue Barnes, RN, CIC, FAPIC is an independent clinical consultant, Board certified in Infection Control and Prevention, a Fellow of APIC (FAPIC) and co-founder of the National Corporate IP Director Network. She currently provides marketing and clinical consultation to select industry partners who seek to support infection prevention with innovative products.
1. CDC Web page Antibiotic/Antimicrobial Resistance (AR/AMR) https://www.cdc.gov/drugresistance/
2. Dall C. New rule requires antibiotic stewardship programs in U.S. hospitals. Center for Infectious Disease Research and Policy; Sept. 26, 3019.
3. Weissenbach M. et al. Exploring the role of infection preventionists in antimicrobial stewardship programs through several lenses: A brief report. Am J Infect Control. 48 (2020) 106-107.
4. Manning, M et al. Antimicrobial stewardship and infection prevention—leveraging the synergy: A position paper update. A J Infect Control. Volume 46, Issue 4, 364 – 368.
5. Billings C et al. Advancing the profession: An updated future-oriented competency model for professional development in infection prevention and control. Am J Infect Control. 47 (2019) 602-614.
6. Moehring R et al. Challenges in Preparation of Cumulative Antibiogram Reports for Community Hospitals; J Clin Microbiol. Aug 2015, 53 (9) 2977-2982.
7. Perri L. The Infection Preventionist's Role in Antimicrobial Stewardship Programs. Infection Control Today. Oct. 6, 2017.
8. Al-Homaidan HT, Barrimah IE. Physicians' knowledge, expectations, and practice regarding antibiotic use in primary health care. Int J Health Sci (Qassim). 2018;12(3):18–24.
9. Duggan C, Joynes R, Rosado H. Pharmacy’s role in antimicrobial resistance and stewardship. Clinical Pharmacist. June 5, 2018.
Outbreak Readiness: How Prepared is Your Facility?
By Phenelle Segal, RN, CIC, FAPIC
Editor's note: This column originally appeared in the March 2020 issue of Healthcare Hygiene magazine.
For at least two decades, the U.S. has been planning for inevitable global pandemics, as evidenced by doubling of the National Institutes of Health (NIH) budget for biomedical research in 1998. The President’s Emergency Plan for AIDS Relief (PEPFAR) was created to stem the rising fear of devastation from Human Immunodeficiency Virus (HIV). However, health crises such as severe acute respiratory syndrome (SARS) that emerged in 2002, and Ebola in 2014, the U.S. response, together with the rest of the world, was considered slow and not well organized. Ebola proved that if basic systems had been in place, the epidemic could have been aborted at almost no cost, compared to the $5.4 billion that the U.S. funded.
Curbing epidemics is complex and requires a combination of money, additional manpower and with modern technology, the ability to diagnose, treat and prevent these diseases should be simpler.1
This article focuses on improvements nationwide for pandemic preparedness using Ebola’s arrival in the U.S. in 2014. Ebola Virus Disease (EVD) created an urgent need for pandemic preparation when the primary patient responsible for introducing the virus into the country fell through the cracks after his initial visit to a hospital in Texas. Ebola preparedness placed a heavy financial and human resource burden on healthcare facilities across the nation. Acute-care hospitals were provided guidance by the Centers for Disease Control and Prevention (CDC) via their “Interim Guidance for Preparing Frontline Healthcare Facilities for Patients Under Investigation (PUIs) for Ebola Virus Disease (EVD).” CDC guidance also included a detailed checklist for hospitals and specified that this could be used for Ebola as well as other infectious diseases. The result was much-improved awareness and preparedness for the inevitable; however, the question remains whether the healthcare industry can ever be fully prepared?
Novel respiratory viruses including severe acute respiratory syndrome (SARS Co-V) in 2003, H1N1 influenza (swine flu) in 2009 and Middle East respiratory syndrome (MERS Co-V) in 2012 reminded the world that ongoing preparation -- particularly in the acute-care setting -- is vital to the success of preventing an outbreak of major magnitude.
Once again, the U.S. currently faces the threat of a respiratory virus outbreak with the novel coronavirus known as COVID-19 that originates from and has sickened tens of thousands of people in China. The death toll has surpassed 1,500 at the time of writing. Similar to SARS and MERS, most often the virus spreads from respiratory droplets as a person-to-person transmission, when a person who is infected sneezes or coughs within the space of approximately 6 feet of others. As this novel virus has many unanswered questions to date, it is not certain whether surface contamination can infect mucus membranes including the mouth, nose or eyes.
Are We Prepared?
In October 2018, the U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released a report, “Hospitals Reported Improved Preparedness for Emerging Infectious Diseases After the Ebola Outbreak.” The OIG found that most acute-care hospitals in the nation were unprepared for the outbreak of Ebola in 2014, “…with 71 percent of hospital administrators reporting that their facilities were unprepared to receive Ebola patients. By 2017, administrators from only 14 percent of hospitals reported their facilities were still unprepared for emerging infectious disease (EID) threats such as Ebola.” Hospitals began updating their emergency plans, provided education and training for staff, particularly front-line staff, purchasing additional supplies and the very important task of conducting drills. HHS provided many resources, and these are available to date. The greatest challenges for hospitals to maintain preparedness includes immediate and day-to-day priorities taking precedence, preparing for natural disasters and staff time. In December 2014 it was reported that state health officials had designated 35 hospitals as “Ebola centers” and were ready to accept patients if necessary.
Pandemic Preparation for COVID-19
Outbreak or pandemic readiness is multi-layered and requires effort at the federal, state, local and individual facility levels, as evidenced by Ebola.
Pandemic preparation guidance for COVID-19 is changing daily as the experts learn more about this evolving illness. CDC continues to provide ongoing updates to healthcare professionals. These guidelines are extensive, and many resources are available for healthcare professionals in acute-care hospitals and for emergency medical service (EMS) personnel. Guidance for outpatient care and other inpatient facilities has not been provided at this juncture; however, the CDC does recommend that all healthcare providers and facilities refer to the guidelines to keep updated on the evolving situation. Key components to effective containment of this emerging virus include the following:
Evaluating and Reporting Persons Under Investigation (PUI)
The CDC clinical criteria for a 2019-nCoV person under investigation (PUI) have been developed based on what is known about MERS-CoV and SARS-CoV and are subject to change as additional information becomes available. Healthcare providers should obtain a detailed travel history for patients being evaluated with fever and acute respiratory illness. The CDC’s guidance for evaluating and reporting a PUI for MERS-CoV remains unchanged.
Criteria to Guide Evaluation of Persons Under Investigation (PUI) for 2019-nCoV
For any patient meeting criteria for evaluation for COVID-19, clinicians are encouraged to contact and collaborate with their state or local health department. For patients that are severely ill, evaluation for COVID-19 may be considered even if a known source of exposure has not been identified
Recommendations for Reporting, Testing and Specimen Collection
Healthcare providers should immediately notify both infection control personnel at their healthcare facility and their local or state health department in the event of a PUI for 2019-nCoV. State health departments that have identified a PUI should immediately contact CDC’s Emergency Operations Center (EOC).
Interim Healthcare Infection Prevention and Control Recommendations for Persons Under Investigation for 2019-nCoV
This section of the guidance is extensive and includes but is not limited to “Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Health Care Settings.
PPE for Healthcare Personnel
As the guidance states, “Healthcare personnel can protect themselves when caring for patients by adhering to infection prevention and control practices, which includes the appropriate use of engineering controls, administrative controls, and personal protective equipment (PPE). The CDC has issued guidance recommending the use of PPE for healthcare personnel caring for patients with confirmed or possible 2019-nCoV infection.”
In summary, emerging pathogens capable of spreading easily from person to person create a vulnerable and potentially dangerous situation worldwide, with the threat of outbreaks at any time. Immunity is usually absent, resulting in potentially severe repercussions for infected patients. History has shown that four influenza pandemics have occurred between 1918 and 2009. In addition, Ebola, the first hemorrhagic viral disease arrived in 2014.
Government, state and local agencies are working diligently to ensure that guidelines and resources are available for healthcare professionals, including those working in acute-care facilities, to prepare for an isolated patient or an influx of patients. It is the responsibility of these facilities to ensure that action plans for pandemic preparedness are developed, implemented, enforced and tested by performing drills at various times, to ensure that at any moment in time, they are prepared for the inevitable.
Phenelle Segal, RN, CIC, FAPIC, is president of Infection Control Consulting Services.
What to Look for in a Vendor Partner
By Linda Homan, RN, BSN, CIC
This article originally appeared in the February 2020 issue of Healthcare Hygiene magazine.
When it comes to infection prevention, we all want a silver bullet, a quick fix that cuts through complexity and provides an immediate solution to a problem. In truth, there is no silver bullet, but there are fundamental infection prevention measures that are proven to be effective in reducing healthcare-associated infections, such as hand hygiene, environmental hygiene, and instrument reprocessing.
In 2010, Wenzel and Edmond introduced the concept of horizontal and vertical infection prevention measures.1 Vertical measures are pathogen-based, reducing infection or colonization caused by specific pathogens in selected patient populations. They are often higher cost interventions as they may involve a microbiologic screening test, and they often are more resource intensive. Examples of vertical interventions are nasal decolonization to prevent transmission of MRSA, MDRO active surveillance and isolation precautions all of which are labor intensive and add cost to patient care. Horizontal measures are already part of routine patient care, are applied to all patients and are equally effective against superbugs as they work against garden-variety organisms.
Horizontal measures are generally less costly than vertical interventions and are consistent with patients’ need to avoid all infections, not just those due to specific organisms.2 The challenge is that horizontal measures often require modification of the day-to-day behaviors of healthcare workers, which means they are more difficult to sustain. They require ongoing education and feedback around a standardized process and buy-in from healthcare workers themselves in order to consistently practice the desired behavior. Hand hygiene, environmental cleaning and disinfection, and instrument reprocessing are horizontal measures and they include not only efficacious products, but also evidence-based processes and diligent practice by healthcare workers.
Product + Process + Practice = Sustained Performance Improvement
When it comes to horizontal infection prevention measures, it is not enough for vendors to offer a product and make a sale. Vendors should be held to a higher standard – they should be vendor partners. A vendor partner is an extension of your team and an asset to your hospital’s success. They are a partner who works with you from identifying a need and supplying a solution, to implementing and sustaining improvement with your facility’s team. It is not transactional, and it is not just a product.
Why should hospitals expect this level of service from their vendors? Because healthcare is complicated and changing quickly. Hospital margins are being pinched. Staff are being asked to do more with less. There are emerging pathogens that are threatening patient safety. A vendor partner’s goal should be your ongoing success as a healthcare provider – sustained performance improvement. But, in order to succeed in this new healthcare environment, we must move past that transactional relationship to a partner relationship that holds vendors to a higher standard and makes them part of a holistic, long-term solution.
A good vendor partner will provide:
- A strong business case to help stakeholders understand the value of the solution
- Data and actionable insights that are easy to understand and drive continuous improvement
- Education in a variety of formats and languages
- Timely and comprehensive on-site service
- A solution that easily integrates into existing workflows
- Onsite customer support to ensure a solution’s success
They must also be willing to partner with customers to standardize processes and improve healthcare worker practices. This requires evidence-based protocols, education and objective performance feedback so that hospitals understand exactly how they can make improvements. It’s a partnership that addresses not only at the product, but the processes and practices that will deliver performance.
I have worked on the business side of infection prevention for many years, but prior to that I was a practicing infection preventionist, certified wound care specialist and nurse manager for just as many years. In the infection prevention and wound specialist roles I worked with many vendors. Some were transactional – they would try to sell me something and, once sold, walk away - no educational support, no follow up, no ongoing connection. Others were more focused on establishing trust and partnership.
One of the most influential people in my career in those days was a sales representative for a wound care company. She was a wound, ostomy continence nurse herself prior to going into sales, and she taught me a lot -- not just about the dressings she was selling, but about wound care itself. She encouraged me to gain expertise that enabled me to take the exam to become a certified wound care specialist, which I did. I went on to become an infection preventionist and, recognizing the value of certification, quickly became certified in infection prevention and control.
The point of this short autobiographical sketch is to highlight the different approaches that manufacturers and their representatives have toward the customer. Some are transactional, some are partners. My wound care sales representative wasn’t just selling me a product, she was a consultant, providing me with the tools and information I needed to help my team improve patient care. Depending on what you are purchasing, either approach might be right. If you are purchasing tongue depressors, a transactional approach makes sense. However, if you are purchasing something more complex that needs to fit into your facility’s workflow, such as a product or service that has an impact on patient outcomes and hospital margins, then a vendor partnership is in order because they will help you see blind spots and opportunities for improvement and help you incorporate them into your facility’s operations. It is another set of eyes, a helping hand, a partnership. It makes sense.
Here are some things to look for in a vendor partner throughout the sales cycle:
Before vendor partners suggest a solution, they should ask you about your facility. They should be listening to you and your challenges – problems that you’re trying to solve but haven’t been able to yet. Once they understand your operations, only then can they suggest solutions that can meet your needs. They should also be asking you about your facility’s demographics such as:
O Basic facility statistics (size, beds, etc.)
O Facility ratings
O Publicly available infection rates
O Patient population in your hospital
O Hospital and system strategic initiatives
Before asking for your business, vendor partners should provide you with strong, evidence-based resources to support their products. You don’t need to see clinical studies to decide which tongue depressor to buy, but, if the vendor is claiming to improve patient outcomes or operational efficiency, evidence is needed. Here is an example: not all efficacy claims need to be supported by a randomized, controlled trial. If a disinfectant has an EPA claim as a sporicide, a clinical study to prove that it kills spores is not necessary because EPA registration ensures that the product kills spores. The claim that the same sporicide reduces C. difficile infection rates when used as part of an overall environmental hygiene program, however, should be substantiated by clinical evidence.
Vendor partners should also be sharing their knowledge of industry trends. They focus on emerging issues and technology in their area of expertise and can help you “see around the corner” so that you’re prepared for what is coming next.
Some products and services require a trial before deciding to purchase. While your hospital may have unique circumstances to take into consideration, a strong vendor partner has a well-defined process to ensure an effective trial that can account for your circumstances. They will also have the resources (product, tools, training and people) to support the trial so that you aren’t taking on all the work by yourself. Remember, their job is to make your work better.
Before a trial begins though, it is critical that you and the vendor partner agree on metrics for success. The success criteria should be objective, measurable and achievable within the timeframe of the trial. For instance, while a product may help reduce healthcare-associated infections, the outcome measure of infection rate reduction is not measurable within the timeframe of a one-month trial. Rather, evaluate the process measure. During a trial for an electronic hand hygiene compliance monitoring system, one can measure the impact of the system on the process measure of hand hygiene compliance, but not the outcome measure of HAI reduction – that simply requires more time.
Vendor partners help provide you with talking points for key conversations with hospital stakeholders by anticipating what questions will be asked, knowing stakeholder priorities, and providing appropriate data to share.
Once you’ve decided to take a product to the value analysis committee, vendor partners can help you prepare messaging that presents your case convincingly and helps stakeholders understand why they need to take your recommended actions. They do this by helping you:
O Target your message to the audience. Top priorities for a c-level executive are different than those of clinical staff, for instance, and top priorities for a CEO are not the same for CFOs or COOs either.
O Make strong comparisons. Compare the value of the solution you are recommending to what is currently being done.
O Bring the evidence. Provide well-supported research, studies, and other data that support your recommendation and resonate with your stakeholders.
The collaborative vendor partner’s work is just beginning once the product has been approved for purchase. Work with your vendor partner to map out the implementation timeline and process. They should provide in-person education and training along with leave behind train-the-trainer resources for you to use when training new employees or providing refresher training.
And, because it’s difficult to measure or make improvements without good data, digital technology plays an increasing role in this space because it provides hospitals with actionable insights that they can use for continuous improvement. Vendor partners should provide comprehensive training on the collection, analysis and reporting of any insights that are derived as part of the product or service.
They will also help you evaluate what’s working and make contingency plans for addressing results that aren’t what you expect.
Ongoing support and partnership
Ongoing support and partnership are key deliverables from a vendor partner. The relationship doesn’t end with a purchase. Vendor partners should review data, provide education, follow up and service on a regular, mutually agreed upon cadence to ensure that you’re reaping the benefits of said solution. This is especially important when the solution being implemented is intended to drive behavior change such as hand hygiene or environmental hygiene compliance – it simply doesn’t happen overnight. It is a process that is optimized over time to accommodate your facility’s evolving needs.
When solving for complex issues that require behavior change, hospitals should be looking beyond products for a more holistic and long-term solution. Hospitals can improve results by partnering with vendors who work alongside them to develop lasting, customized, and programmatic solutions that address their specific needs. Something I think hospitals expect, but shouldn’t, is that improvements will fade (regress to the mean) over time. In fact, they should expect and be armed with the products, processes and practices that will continuously improve their performance over the lifetime of the solution.
Change can be hard, especially when it involves adjustments to behavior, but with the right vendor partner it is possible for hospitals to make comprehensive and sustainable improvements to horizontal measures that impact clinical and operational outcomes, while also cultivating the financial wellness of the hospital. Products alone simply don’t cut it anymore – hospitals can and should expect more from their vendor partners.
Linda Homan, RN, BSN, CIC, is senior manager of clinical affairs for Ecolab Healthcare.
- Wenzel RP, Edmond MB. Infection Control: The case for horizontal rather than vertical interventional programs. Int J Inf Dis 2010; S3-S5.
- Edmond MB, Wenzel RP. Screening Inpatients for MRSA — Case Closed. N Engl J Med 2013; 368:2314-2315.
The Role of the Infection Preventionist in Product Purchasing
By Sue Barnes, RN, CIC, FAPIC
This column originally appeared in the February 2020 issue of Healthcare Hygiene magazine.
As healthcare costs continue to rise, the process of selection of clinical products must be objective and scientific. Because there are so many elements involved during this process, coordination by the value analysis committee is critical to ensuring both patient safety and cost containment. In the role as a core member of this committee, the infection preventionist (IP) serves a number of functions including:1,2
• Bringing formal proposals for the introduction of infection prevention products/technology incorporating evidence of efficacy and estimated return on investment (ROI);
• Providing consultation regarding the safety and efficacy of less expensive products supporting prevention of HAI, that may be proposed by the committee as a cost saving measure;
• Providing important guidance to ensure that any product or technology introduced can be effectively cleaned and disinfected if used on or around patients, and to ensure that the recommended products for cleaning/disinfecting are compatible with those in use at the facility;
• Supporting the committee’s assurance of a vendor’s capacity to provide adequate staff training in real time so that the product/technology will be used appropriately and result in optimal outcomes;
• Ensuring that any infection prevention product meets all evidence-based clinical guidelines and recommendations from regulatory and clinical organizations including the CDC.
Related to and supporting these functions are the additional important roles played by effective IPs, of early adopter and principle investigator for trials of innovative products supporting prevention of healthcare associated infection (HAI).3,4 A classic example of the IP role as early adopter has been demonstrated with the range of chlorhexidine gluconate (CHG) containing products. It was far in advance of randomized clinical trials proving efficacy of CHG in reducing infection risk, that IP departments began championing CHG based products starting with healthcare hand soap in the 1970s.5 It subsequently became a community standard and then decades later the Centers for Disease Control and Prevention (CDC) finally added it as a recommended practice in 2002.5 Similar time gaps can be seen between implementation of many other CHG containing products and the publication of randomized controlled trials and clinical guideline integration for infection prevention, including vascular access skin prep, impregnated central venous catheters, impregnated surgical and vascular dressings.5 In the absence of patient risk, many IPs champion products based on early evidence of efficacy in order to optimize patient safety. It is a certainty that many patient lives have been saved as a result of this philosophy of early adoption.
The role of principle investigator and/or participant in studies of innovative products is equally important in the quest for zero preventable HAI. From simple before and after studies, to large double blind randomized controlled studies, IPs have participated in and led trials of innovative products designed to reduce HAI risk, building the evidence base for efficacy. This typically initially leads, often only after many years. to establishing a community standard, and then much later to inclusion in clinical guideline(s).6
IP and Industry Collaboration
From the frontlines of healthcare in hospitals and clinics to the corporate offices of the Association for
Professionals in Infection Control and Epidemiology (APIC), IPs work collaboratively with industry partners to
introduce innovative products and technology designed to optimize patient safety by reducing HAI risk.7 At the
corporate level the APIC Strategic Partner Program is a formal, mutually beneficial partnership between APIC
and Industry Partners united in the common goal of reducing the risk of infection. The industry partners play an important role in supporting many of the programs and services that makes the APIC membership so valuable. More recently Industry Perspectives has been introduced by APIC, an online resource for IPs and healthcare workers to stay up-to-date on products, services, research, and innovation relevant to the field of infection prevention and control.
An important opportunity for IP professionals at all levels to learn about new infection prevention products, and develop relationships with industry partners, occurs annually during conferences including the annual meetings of APIC and the Society for Healthcare Epidemiology of America (SHEA). When visiting the vendor exhibit-hall during these conferences it’s helpful to be prepared with a few standard questions for vendors such as:
1. What studies providing evidence of efficacy have been published in peer reviewed journals and/or presented at conferences?
2. Does the data available address reduction of bacterial loads only, or also reduction of infection rates?
3. Can the vendor connect you with an IP at another facility using the product with good results?
Industry partners often offer a range of supportive services that can be leveraged by IP departments to reduce diversion of constrained IP resources. For instance, since tracking of compliance with appropriate product use is time consuming, this is a significant value-added service often provided by industry partners. Most vendors are also willing and able to partner with the clinical teams to provide direct observation, coaching and teaching when new product(s) are introduced. Collaboration between industry partners and IP professionals simply makes patients safer.
1. Henry A. Product Evaluation. APIC Text Online Chapter 5; October 3, 2014.
2. Valenti W. Infection control and product evaluation. Infectious Disease Advisor - Hospital Infection Control. 2017.
3. Conway L et al. Tensions inherent in the evolving role of the infection preventionist. Am J Infect Control. Vol. 41, No. 11, 959-964.
4. Barnes S, et al The emerging role of the corporate or system-level infection prevention director for integrated delivery networks. Am J Infect Control. Vol. 47, No. 6, 638-642.
5. Chlorhexidine Facts: https://chlorhexidinefacts.com/
6. Pyrek K. Injecting the research and resources into infection prevention. Infection Control Today. May 17, 2018.
7. Humphreys H. New technologies in the prevention and control of healthcare-associated infection, J R Coll Physicians Edinb. 2010 Jun;40(2):161-4.
Leading the Way to Zero: Moving Purposefully Forward Together
By Sylvia Garcia, MBA, RN, CIC
This column originally appeared in the January 2020 issue of Healthcare Hygiene magazine.
At the opening of the 2006 annual meeting of the Association for Professionals in Infection Control and Epidemiology (APIC), then-APIC president Kathleen Arias said, “Zero tolerance is not a number—it’s a culture in which healthcare providers strive to prevent as many healthcare-associated infections as possible. We may never eliminate every infection, and many cannot be prevented, but infection control professionals should accept nothing less than the very lowest rates of infection.”
Back then, I sat in the audience and thought to myself, great idea, but is it achievable? Which infections should we prioritize? What are the key interventions? How do we get support from leadership and staff? (I wasn’t even thinking about the patient or their family at that point.)
There were already evidence-based guidelines available from Centers for Disease Control and Prevention (CDC) and other professional organizations on a variety of key topics. The next year, the Centers for Medicare & Medicaid Services (CMS) published payment reforms intended to increase emphasis on value-based purchasing which identified central line-associated bloodstream infections (CLABSI) and indwelling catheter-associated urinary tract infections (CAUTI) as “never events.” So, I knew CLABSI and CAUTI would be on leaderships’ list of priorities, but was this enough?
The answer would become clearer during 2008 when the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), the American Hospital Association (AHA), APIC, and the Joint Commission worked together to create the Compendium of strategies to prevent healthcare-associated infections in acute-care hospitals. These documents focused on implementation of basic strategies to prevent the most common healthcare associated infections (HAIs) as well as providing special approaches when basic practices were not enough. They also recommended that accountability be assigned and proposed performance metrics to monitor quality improvement efforts.
Information from the CDC, the Compendium and other professional organizations soon became an even greater organizational priority when the Joint Commission added three new requirements to national patient safety goal (NPSG) 7: Reduce the Risk of Healthcare Associated Infection in 2009 and an additional topic area in 2012
• Implement evidence-based practices to prevent health care–associated infections due to multidrug-resistant organisms (MDRO)
• Implement evidence-based practices to prevent CLABSI
• Implement evidence-based practices for preventing surgical site infections (SSI)
• Implement evidence-based practices to prevent CA-UTI
Today, the results of concentrated efforts to identify key interventions and reduce risk by implementing evidence-based practices are clear. Nationally, among acute care hospitals, significant progress has been made. For example, between 2017 and 2018, an 8 percent to 12 percent statistically significant decrease in CAUTI, CLABSI and hospital-onset C. difficile infections was reported. However, there was no significant decrease in SSI rates.
According to point prevalence surveys of hospitals conducted in 2011 and then again in 2015, there has also been a statically significant (p<0.0001) decrease in HAI amongst hospitalized patients: 1 in 25 (4 percent) versus 1 in 31 (3.2 percent), respectively. Pneumonia, gastrointestinal infections (most of which were due to Clostridium difficile) and surgical-site infections were the most common health care-associated infections infection identified.
As the following NPSGs are moved to standards effective July 1, 2020, organizations need to continue to implement evidence-based practices.
• NPSG.07.03.01—Multidrug-resistant organisms
• NPSG.07.04.01—Central line–associated bloodstream infections
• NPSG.07.05.01—Surgical site infections
• NPSG.07.06.01—Catheter-associated urinary tract infections
Organizations should also be aware that in November 2019, the CDC released a report about the threat of antibiotic-resistant organisms and the statistics are eye-opening: “…antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and 35,000 deaths in the United States each year. That means, on average, someone in the United States gets an antibiotic-resistant infection every 11 seconds and every 15 minutes someone dies.”
To keep patients, visitors and staff safe, organizations should be ready to implement CDCs recommended containment strategies when these organisms are identified. This includes ensuring compliance with existing Joint Commission focus areas, including:
• Implementation of standard and transmission-based precautions
• Making appropriate personal protective equipment available to staff
• Training staff on selection, limitations, maintenance, donning and removal of personal protective equipment
• Enforcing use of appropriate personal protective equipment
Note: Examples of potential survey findings related to the aforementioned areas were published in the August 2019 edition of Perspectives, under the “Consistent Interpretations” section.
We are making progress but there is still much work to be done both for the common infections that occur in healthcare such as SSI, and those, such as antibiotic resistant organism and other high- consequence organisms, that loom on the horizon.
Each healthcare organization needs to look within and conduct an accurate risk assessment – and ask: where are the low hanging fruit and the biggest risks? Are leadership, staff, patients, their families and their significant others are involved? And, is everyone working together to prioritize, plan, implement, and monitor?
If we all hold ourselves and our colleagues responsible and accountable…together we can get to zero HAIs!
So, 14 years later, do I think that we can achieve zero HAIs? My answer is a resounding Yes!
Sylvia Garcia, MBA, RN, CIC, is director of infection prevention and control within the of Division of Healthcare Improvement at the Joint Commission.
1. Association for Professionals in Infection Control and Epidemiology. Prevention Strategist. 40 Years of Growth and Progress. Winter 2012.
2. Centers for Medicare & Medicaid Services (CMS), HHS. Medicare program: changes to the hospital inpatient prospective payment systems and fiscal year 2008 rates. Federal Register. 2007;72(162):47129–48175.
3. Centers for Disease Control and Prevention. 2018 National and State Healthcare-Associated Infections Progress Report. Available at: https://www.cdc.gov/hai/data/portal/progress-report.html
4. Magill SS, et.al. Changes in prevalence of healthcare associated infections in U.S. Hospitals. N Eng J Med. 2018 Nov 1;379(18):1732-1744. doi: 10.1056/NEJMoa1801550
5. Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States – 2019. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf .
6. Centers for Disease Control and Prevention. Containment Strategy Responding to Emerging AR Threats. Available at: https://www.cdc.gov/hai/containment/index.html.
Screening for Asymptomatic Bacteriuria: A Dangerous Intersection
By Barbara DeBaun, MSN, RN, CIC
This column originally appeared in the December 2019 issue of Healthcare Hygiene magazine.
It was a dark and stormy specimen. You know the story. It begins with a well-meaning nurse who notices that the urine in the patient’s urinary drainage bag is dark in color. When the urine is drained from the bag, the nurse notes that the urine is not only concentrated but smelly. More likely than not, this nurse will collect a sample of the urine and request an order for urinalysis and culture. The nurse has seen this before and is confident the patient’s symptoms suggest a urinary tract infection.
Another twist on the story is the patient who presents in the emergency department (ED) and whose daughter or son insists that “When mom gets like this, it’s always a urinary tract infection.” Sound familiar?
Asymptomatic bacteriuria (ASB) is the presence of one or more species of bacteria growing in the urine at specified quantitative counts (≥10⁵ colony forming units (CFU/mL or ≥10⁸ CFU/L regardless of whether there is presence of pyuria or signs/symptoms that are attributable to an urinary tract infection.
What do we know about ASB?
- Present in >30 percent of nursing home patients and 100 percent of those who are chronically catheterized
- 23 percent to 50 percent of antibiotic days for UTI are unnecessary treatment of ASB
- ASB is a benign condition that generally does not require treatment
Urine culturing misadventures often begin when a patient with a low pre-test probability of having a UTI is tested for one. It may start when a physician orders a urinalysis and culture on a patient who is unlikely to have a UTI, or in the scenario previously described, when a nurse obtains the specimen first and requests the order later. The integrity of the specimen including technique for obtaining and transporting it will impact the result.
Despite our best efforts, we still hear of urine samples being obtained directly from urinary catheter drainage bags. It is not unusual for a urine sample to be considered low priority for transfer to the lab therefore overgrowth of bacteria may result. The downstream impact of this includes additional work for the laboratory, increased costs for the pharmacy, and a negative impact on antimicrobial stewardship. Infection Preventionists are tasked with reporting hospital onset catheter associated urinary tract infections (CAUTI) and are likely reporting cases that are not true infections despite meeting the NHSN case definition. Financial penalties and impact on reimbursement are impacted by a substandard culture of culturing. The ultimate negative impact of culturing patients for an infection that is probably not likely, is that patients receive antibiotics that are not necessary.
The Infectious Diseases Society of America (IDSA) recently issued a clinical practice guideline for the management of asymptomatic bacteriuria. These 2005 guidelines recommended that only pregnant women and those scheduled to have an invasive urologic procedure be screened for ASB. The updated guidelines provide additional guidance on children and specific adult populations such as those with neutropenia, solid organ transplants, and surgery that does not involve the urological tract. Much has been learned about the impact of testing for ASB in these settings therefore the Society has provided guidance that will ultimately impact antimicrobial prescribing and the emergence of antimicrobial resistance.
An all-too-common practice is for practitioners to test a patient who has been admitted to an acute-care hospital with an indwelling catheter. The temptation to screen may be based upon the pressure to “capture on admission” or prove that the patient was already “infected” at the time of admission. The IDSA strongly advises against screening or treating ASB. As the screening of patients admitted with a catheter are likely to present in the ED, it is critical to partner with the ED providers and nurses so they are aware of the negative impact of performing urine screening in patients who are unlikely to have a UTI.
An additional strong recommendation is to avoid screening patients who are scheduled to undergo elective nonurological surgery for ASB. This is an area where the IP has tremendous opportunity to impact and drive change. Pre-operative order sets commonly include “urinalysis” and it may be “because we have always done it and we’re afraid to stop doing it.” We must have critical conversations with our surgical partners to discuss the impact of ASB screening to assure them that the risk of testing may outweigh the benefits. A patient scheduled for a knee replacement will be far better off if s/he is not treated with an antibiotic for ASB. There are no data to support the benefit of urine screening for nonurological surgical patients, however there is an abundance of data to connect antimicrobial therapy with negative downstream effects such as multi-resistant organisms and C. difficile infection.
Our laboratory “culture of culturing” practices that discourage the screening of patients who have a low probability of having a UTI directly impact antimicrobial prescribing practices and patient outcomes. This requires a partnership that connects the dots between laboratory stewardship and antimicrobial stewardship so that antibiotics are only prescribed when they should be.
Barbara DeBaun, MSN, RN, CIC, is an improvement advisor for Cynosure Health.
Education and Training of Frontline Infection Preventionists
By Matthew Hardwick, PhD
This column originally appeared in the November 2019 issue of Healthcare Hygiene magazine.
One of the most fundamental operations in any medical facility is cleaning. Cleaning critical areas such as patient rooms and surgical suites, as well as, less critical areas such as waiting rooms, hallways, cafeterias, kitchens, etc. are all apart of keeping medical facilities free of pests and, hopefully, pathogens. However, for the longest time, cleaning hospitals has followed the same basic principles as cleaning a hotel room -- clean visible soil. While there are cleaning protocols in place at nearly all medical facilities, the predominant feature of these protocols is routine cleaning with a focus on visible soil. It should come as a surprise to no one that pathogens do not always reside in visible soil. Indeed, many of the fluids and semi-solids that pathogens use to move from place to place are not readily visible to the naked eye (think sputum or fingerprint oils). Despite this fact, many cleaning protocols do not take invisible soil into account during both routine and specialized cleaning protocols. The responsibility for this lack of awareness belongs to all involved in healthcare. While environmental service (EVS) personnel, nurses and technicians are primarily responsible for keeping our medical facilities and equipment clean, they are only as good as they are trained to be.
From the Centers for Disease Control and Prevention (CDC) to the Association for the Healthcare Environment (AHE) to the Association for Professionals in Infection Control and Epidemiology (APIC), all agree that EVS personnel require extensive training to play their pivotal role in keeping healthcare environments free of pathogens. Indeed, each has dedicated significant resources to developing training programs for EVS workers. AHE has a suite of training programs aimed at frontline EVS workers to surgical suite cleaning to EVS management and leadership. Through funding from the CDC, APIC has developed training modules that run the gamut of cleaning from the basic principles, personal protective equipment, chemical safety, and techniques for cleaning and disinfection. In addition to these resources, vendors have developed their own extensive training for EVS workers. Such training is, perhaps, more individualized and often encompasses multiple days for training sessions and accompanied by annual refreshers for each worker.
- Fluorescent markers – This tool was developed in order to provide “before” and “after” feedback for EVS workers. In short, an invisible fluorescent gel is applied to pre-determined surfaces prior to EVS cleaning. Following cleaning, a manager uses a black light to determine if the gel has been removed from all the spots. In this way, the manager can determine adherence to cleaning protocols. It should be noted, however, that this method does not determine the efficacy of removing pathogens from environment.
- Adenosine Triphosphate (ATP) swabs – One way to determine if a surface is free of pathogens is to detect organic ATP (derived from biological organisms like bacteria, fungi and human cells) left on surfaces. ATP detection is performed only following cleaning, reducing the time needed for monitoring. In theory, this method will not only determine an EVS workers adherence to established cleaning protocols, it will also evaluate the protocol for pathogen removal. There is one big problem with this method, however. First, we do not know the half-life of biologically derived ATP, meaning that cells maybe dead (killed by auxiliary techniques such as UV and vapor) and still leave active ATP behind. In our laboratory, we have detected ATP signals in the absence of viable bacterial loads, more than 48 hours after exposure to UV light.
The development of fluorescent marker and ATP swab methodologies are a boon to the education and monitoring of EVS workers. However, given the limitations of both the current cleaning methodologies and these monitoring devices, we still have a long way to go before we have adequate tools to empower EVS workers.
While EVS personnel receive considerable training, nurses and technicians may only receive cursory training, if any at all, on how to clean medical equipment and how to use disinfectants. APIC’s training does include sections for healthcare professionals including a section on “roles and responsibilities” geared toward who cleans what in healthcare environments. Despite APIC’s efforts, there is clearly a gap in training for nurses and technicians. This education and training gap is critical, since these individuals are largely responsible for cleaning critical patient-care equipment such as blood pressure monitors and dialysis machines. Without understanding which disinfectant to use and the appropriate dwell times, as well as how to use wipers in order to reduce cross-contamination, we cannot begin to hope that healthcare surfaces will be cleaned properly.
In last month’s Healthcare Hygiene magazine, Linda Lybert and Caroline Etland described a comprehensive literature review commissioned by the Healthcare Surfaces Institute. As a part of this review, studies on current healthcare training and education were examined. Despite the availability of numerous training programs and studies to show that only 48 percent of healthcare surfaces are cleaned appropriately, no research studies were found to determine if these programs are effective. Rather, only a handful of research studies were focused on monitoring cleaning practices. This lack of scientific research into the effectiveness of EVS training is surprising and, frankly, appalling.
Given the rapidly evolving world of infection prevention, it is critical that all healthcare professionals – EVS workers, nurses, technicians – receive the education and training they need to fill their roles as frontline infection preventionists.
Matthew Hardwick, PhD is president/CEO of ResInnova Laboratories and is the president of the board of directors of the Healthcare Surfaces Institute. He is a thought leader in the field of infection prevention in the healthcare environment of care and is an expert in antimicrobial surface technologies.
When Prime Directives Collide: The Survival Wars
By Wava Truscott, PhD, MBA
This column originally appeared in the November 2019 issue of Healthcare Hygiene magazine.
The Prime Directive driving all humans is an internal instinct to survive. Throughout the ages, man has struggled and adapted to protect himself, his family, and his tribe. This core drive to survive has advanced weapons for protection, from crushing threats with rocks, to throwing spears, and on to more powerful weapons. To survive weather extremes, man huddled in caves, constructed lean-tos, and moved up to more permanent structures of wood, stone, and cement.
The same Prime Directive drives microorganisms to adapt or die. However, instead of innovative adaptations requiring thought, bacteria experience genetic mutations that may, or may not be helpful. Mutations that protect bacteria enable survival, while mutations that are not sufficiently protective die off with the bacteria. For example, those bacteria that received successfully mutations allowing them to withstand temperatures up to 180 degrees F, continue to thrive in the hot springs and steam vents of Yellowstone.
The adaptive capacity of bacteria has been incredibly successful, especially considering they have been on earth for over 1.8 billion years. Most successful mutations are passed on vertically from generation to generation in a long looped single chromosome composed of double-stranded DNA residing in the nucleolus of the bacteria. The instructional information is passed primarily during cell division, enabling future progeny to survive in their environment. These traits include such capabilities as biofilm formation for tribe protection, the ability of a small number of bacteria to form one-occupant spores, and the inherited capability that a few bacteria possess to produce small colony variant (SCV) progeny that, in effect, are invisible to the human immune system.
Some protective mutations can be transferred horizontally to other bacteria unrelated to the original “mutant.” The genetic instructions are encoded in a much smaller double-stranded DNA loop, the plasmid. Plasmids can replicate independently producing as many as needed to “share” with other bacteria. Once a bacterium receives a plasmid, it in turn produces replicates to fortify its own protection and potentially to distribute to others. Plasmids are also vertically passed on to progeny during cell division, thus improving the odds of survival for their descendants.
Antibiotic resistance genes are very successful mutations located on plasmids. The mutations only work on specific antibiotic types and only by specific action modes. There are at least 10 different protection modes that have been successful:
Within the bacterial cell itself:
- Blocks entry of specific antibiotic types trying to enter bacterial cell
- Flushes the antibiotic out of the bacterial cell before it reaches their targets
- Produces enzymes that break apart antibiotics before they reach their targets
- Produce antibiotic modifying enzymes that render the antibiotic ineffective
- Modify the targets so they cannot be impacted by the antibiotic
- Make so many clones of the antibiotic targets, that the antibiotic is spent before destroying all the targets
Within the group-protective biofilm:
- Exo-enzymes distributed throughout the biofilm matrix like land mines in the battlefield, digest specific antibiotic types when contact is made
- Many bacteria in the center of the biofilm, are altered into persister cells that shut down (hibernate), not allowing anything in---including antibiotics
- Most biofilm founding-bacteria attract diverse bacterial types to increase the odds of biofilm survival through genetically diverse protective adaptations
- Proximity and purpose of the (a) peripheral bacteria in a biofilm “fortress” makes them the forward perimeter guards. It is there that plasmids for diverse means of protection are most liberally shared. For example, the more means of defeating antibiotics each defender possess, the more effectively broad the antibiotic resistance. Bacteria deeper in the matrix are responsible for (b) harvesting moisture and nutrients, (c) metabolic waste disposal, (d) hibernating as persister cells, and (e) transforming into “Supper-Surface-Grippers.”
U.S. Daily Human Cost: Each day, approximately 5,000 Americans acquire a serious antibiotic–resistant infection. Of those, about 63 patients will die and a large percentage of survivors will suffer long term chronic consequences. By 2050, it is projected that untreatable antibiotic infections with overtake cancer as the number one cause of death globally.
U.S. Annual Financial Cost: Antibiotic-resistant infections add $20 billion in excess direct health care costs and up to $35 billion the additional costs to society for lost productivity.
As with any battle, attacking before the enemy can establish a foothold and fortify a reservoir of resistant pathogens is by far the easiest, most effective and least costly means of patient protection. It takes a team to do what’s needed including infection preventionists, OR and device reprocessing staff, environmental services, engineering, and clinicians.
Infection preventionists must have help to handle required reports, statistics and trending paperwork so they can be actively on the floors, teaching, advising, admonishing, finding solutions and supporting staff trying to do the right things under pressure.
Infection prevention efforts are becoming more and more imperative. We are facing a clash of Prime Directives between patient and pathogen. Bacteria have almost a 2 billion-year proven record of adapting to survive. We are losing the capability to treat more and more our patients’ infections. We need to adapt tactics, techniques, technologies and responsibilities if we are to win the war for patient survival.
Wava Truscott, PhD, MBA, is principal of Truscott MedSci Associates, LLC.
This article is from the October 2019 issue of Healthcare Hygiene magazine.
Legionella: Recognizing the Risk and the Resources
By Sylvia Garcia, MBA, RN, CIC
Every day, patients are at risk because healthcare facilities are not aware of hazards related to water systems and equipment that uses water, or they have not prioritized it as an important issue. It is estimated by the Centers for Disease Control and Prevention (CDC) that 9 out of 10 infections acquired in a healthcare setting could have been prevented if the facility had initiated a better water management system.
Shockingly, 1 in 4 patients who develop healthcare-associated Legionnaires’ disease will die, compared to one in 10 that will die from community-acquired pneumonia. Even more surprising is the fact that at least 80 percent of the Legionella cases that occur in healthcare facilities could have been prevented by implementing an effective water management program.
The most common sources of Legionella cases are showers, cooling towers, decorative fountains, and hot tubs but anything that can create droplets or aerosols could become a source. For example, putting tap water into a room humidifier could lead to infection. About half of Legionella outbreaks are linked to incidences associated with human error, such as a health care professional not following instructions for use of equipment.
Although Legionella is highly publicized, it is not the only risk related to health care water systems. At the Association for Professionals in Infection Control and Epidemiology (APIC) 2019 Conference, researchers reported that 22 percent of consultations conducted by the Division of Healthcare Quality Promotion (DHQP) were water related. Causes of patient infections were identified as preventable, had the healthcare organization properly utilized available information and followed procedures communicating the need for the organization to implement an effective water management plan. For example, use of consumer-grade humidifiers in an operating room was linked to an outbreak of nontuberculous mycobacteria. Yet, the 2003 CDC Guidelines for Environmental Infection Control in Health Care Facilities clearly state that this this type of humidifier has been linked to Legionella outbreaks.
As with other infection prevention and control challenges, organizations need to follow a standardized approach to reducing risk related to waterborne disease.
1. Regulatory Requirements. Organizations should know their state’s regulatory requirements. Sources include health department and building code requirement documents. New York has enacted state regulations that require hospitals and residential healthcare facilities to perform environmental assessments, implement sampling and management plans to sample their potable water systems for Legionella and institute control measures in the event of a Legionella exceedance. New York also requires cooling towers to be registered and monitored for Legionella. All states provide or employ Healthcare Associated Infection Liaisons to direct healthcare workers to relevant information.
It is also important to understand state reporting requirements for Legionella and to identify known or suspected outbreaks caused by waterborne pathogens. To meet these requirements, facilities must implement a system to identify and evaluate possible cases. A laboratory finding is usually the first step in identifying a possible case. However, the infection preventionist or other knowledgeable person is also needed to apply generally-accepted case definitions or create a case definition in the outbreak setting.
State building codes vary, but many states have adopted a version of the Facilities Guideline Institute (FGI). Organizations can gain access to relevant building codes or, depending on the year, can access the information directly via FGI’s read-only access. For example, FGI 2014 and 2018 state “provisions based on a risk-assessment plan shall be included in the heated potable water system to limit the amount of Legionella bacteria and opportunistic waterborne pathogens.” For the same reason, unsealed, indoor decorative fountains are prohibited in these versions. FGI also provides excellent references - including CDC Guidelines for Environmental Infection Control in Health Care Facilities, American National Standards/American Society of Heating, Refrigerating and Air-Conditioning Engineers Standard 188: Legionellosis: Risk Management for Building Water Systems, American Society of Heating, Refrigerating and Air-Conditioning Engineers Guideline 12: Minimizing the Risk of Legionellosis Associated with Building Water Systems and the American Society of Plumbing Engineer’s Legionella Control in Health Care.
2. Centers for Medicare and Medicaid Requirements. In July 2018, CMS updated its requirement to reduce Legionella risk in health care facility water systems to prevent cases and outbreaks of Legionnaires’ disease. The updated requirement makes certain that Medicare-certified hospitals, critical-access hospitals and long-term care facilities develop, implement and monitor the effectiveness of water-management programs to protect patients, visitors and staff from exposure to waterborne pathogens, including Legionella pneumophila.
3. Manufacturer Instructions for Use (IFU). Equipment that uses or is connected to water has specific plumbing, filter and/or maintenance requirements. For example: air gaps may be required for plumbing installations; cooling tower instructions-for-use may specify inspection criteria and biocides to maintain biological control; and equipment may indicate use of sterile water or specific frequency for maintenance. In addition, some equipment may specifically state that it is not appropriate for healthcare settings. Careful reading and compliance with IFUs are essential to preventing outbreaks.
4. Evidence-based guidelines and national standards (EBG). CDC, the American Society of Heating, Refrigerating and Air-Conditioning Engineers and many other organizations have created excellent resources for preventing waterborne illness. Key resources from CDC include 2003 CDC Guidelines for Environmental Infection Control in Health Care Facilities Guidelines for Environmental Infection Control in Health care Facilities and the Centers for Disease Control and Prevention Tool kit, which outlines elements of an effective water management system with focus on health care facilities. EGB will include the following key elements:
• Establish a water management team. There is flexibility in qualifications of team members. However, it is important to seek individuals with backgrounds in the following when forming a health care facility team: facilities management, microbiology, infection prevention, risk management and occupational health.
• Describe the building’s current water system. Create a diagram that highlights water points of entry, distribution, storage and use. Most facilities display building drawings that include their plumbing system, so that is a great place to start.
• Identify where Legionella and other pathogens can grow. Facilities should identify at-risk systems and equipment with respect to their components, installation, configuration, use and condition, as well as vulnerability of persons served by these systems.
• Determine control measures and standards for monitoring them. Control measures must be developed for each risk point. Facilities must determine what is planned to be checked to ensure that their control measures are effective. Examples include but are not limited to: monitoring compliance with routine maintenance, water temperature, pH, chlorine levels and cultures. Note: Routine culture testing for Legionella and other pathogens is not required by CMS but may be required by state or local regulation.
• Establish interventions when clinical limits are not met. The expectation is that facilities establish a plan for remedy if a suspected health care-associated case of Legionella is identified or suspected or if control measures are not being met.
• Make sure the program is functioning as designed and is effective. Validate that all control measures have been implemented as designed and procedures have been established to confirm the water management program is effectively controlling water-related hazards.
• Document and communicate. Facilities’ water management programs should be documented. It is important to inform those at risk of the facility plan in place. If a problem occurs, it is required that the incident is reported to the health department.
5. Create a Facility Water-Management Plan. Using the steps, create a team and sort through water management requirements. The Joint Commission looks for evidence of compliance by using following key elements:
• Facility risk assessment to identify where Legionella and other opportunistic waterborne pathogens (e.g. pseudomonas, Acinetobacter, nontuberculous mycobacteria, and fungi) could grow and spread, and to evaluate programs to protect the health and safety of patients. Relevant standards should be recorded for facility water systems or equipment containing or using water.
• A water management program that considers input from the following publications: American Society of Heating, Refrigerating and Air-Conditioning Engineers 188 and the CDC Toolkit. Developing a Water Management program to reduce Legionella growth and spread in buildings: a practical guide to implementing industry standards.
• Testing protocols and acceptable ranges for control measures, with results of testing and corrective actions taken when control limits are not maintained
The Joint Commission surveyors may ask to review IFUs for equipment that uses or contains water. They also may ask about circumstances that could put a facility’s cooling towers or water system at risk.
Surveyors may also ask for a facility’s plan to mitigate risk, which should include identifying:
• System startups and shutdowns
• Areas of the facility that are closed or have low census
• Changes to municipal water treatment
• Water main breaks
• Construction or renovation
• Fluctuations in source water temperature
• Cooling tower maintenance
A systematic approach will ensure that key requirements and prevention strategies are not missed when preventing waterborne pathogens. There is not one solution to this challenge. In fact, water management needs to be uniquely tailored to each health care facility’s building, equipment, water and conditions. Implementing an organized approach, maintaining correct background information and utilizing key resources will help keep people safe from waterborne pathogens.
Sylvia Garcia, MBA, RN, CIC, is the director of infection prevention and control in the Division of Healthcare Improvement. In this role, she is responsible for the oversight of infection prevention and control for The Joint Commission. She has more than 30 years of experience in infection control in both hospital and long term care settings, as well as eight years of clinical microbiology experience. Most recently, she served as the director of infection control at University of Chicago Medicine and was also an intermittent consultant for Joint Commission Resources for 10 years. Garcia has provided infection prevention and control consultation, assessment and education in a variety of healthcare settings including hospitals, health clinics, ambulatory surgery, and dialysis centers both domestically and internationally. Her specialty areas of interest include disinfection and sterilization, dialysis, infection prevention during renovation and construction, and control of Legionella. One of the highlights of her career has been training healthcare professionals in Saudi Arabia as infection preventionists. She served as a test writer and reviewer for the Certification Board of Infection Control and Epidemiology, and has also authored numerous articles and book chapters related to infection control including a chapter in the APIC Text and the Cleaning, Disinfection and Sterilization Chapter in The APIC/JCR Infection Prevention and Control Workbook, Third Edition. Garcia earned a degree in biochemistry and molecular biology from Northwestern University, a master’s of business administration from the Keller Graduate School of Management, and her nursing degree from Truman College.