Keeping Instruments Appropriate for Reprocessing

By Sylvia Garcia-Houchins, RN, MBA, CIC

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.

References:
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
• Leadership
• 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.

References:
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

Sharps Safety
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.

Resources:
• 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

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

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.

References:
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

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.

References:

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

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

Conclusions
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.

References:
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.

References:

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

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.

References
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?

2020 Reflection
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.