Infection Prevention and Control for Community-Based Organizations For Surveys Starting After: January 1, 2019
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Infection Prevention and Control for Community-Based Organizations The Infection Prevention and Control (IPC) standard provides a framework to plan, develop, implement and evaluate effective infection prevention and control activities based on evidence and best practices in the field. The literature shows that well-designed infection prevention and control activities are proven to improve client/resident outcomes, and maintain a healthy workforce. They are also cost-effective because they contribute to fewer health care-associated infections, reduce the need for hospitalization, and decrease the cost of treating health care-associated infections. The standard is intended for infection prevention and control activities in a health care setting outside of a hospital. For the purposes of this standard, a "health care setting" is any location where health care is provided, including long-term care, residential homes, supportive housing, in the client s home (home care and home support), ambulatory care facilities, clinics, and other locations in the community. The standard outlines the key routine practices and additional precautions for effective infection prevention and control, including: Point-of-care risk assessment Hand hygiene Aseptic techniques Personal protective equipment Cleaning and disinfection of the physical environment Sharps safety Safe handling of contaminated items Promoting a collaborative approach for protecting the safety of clients/residents and the team, the Infection Prevention and Control standard contains the following sections: 1. Planning and Developing Infection Prevention and Control Activities 2. Implementing Infection Prevention and Control Activities 3. Evaluating the Impact of Infection Prevention and Control Activities Note on the Reprocessing of Reusable Medical Devices standard The Infection Prevention and Control standard includes content regarding reprocessing of medical devices/equipment. This content applies to teams that conduct reprocessing activities outside of a specific Medical Device Reprocessing Department (MDR). Reprocessing activities that take place in a Medical Device Reprocessing Department are addressed by the Reprocessing of Reusable Medical Devices standard. 1
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Legend: Dimension Population Focus Work with my community to anticipate and meet our needs Continuity of Services Coordinate my care across the continuum Appropriateness Do the right thing to achieve the best results Efficiency Make the best use of resources Worklife Take care of those who take care of me Safety Keep me safe Accessibility Providing timely and equitable services Client-centred Services Partner with me and my family in our care Criteria Types High Priority High priority criteria are criteria related to safety, ethics, risk management, and quality improvement. They are identified in the standards. REQUIRED ORGANIZATIONAL PRACTICE Required Organizational Practices (ROPs) are essential practices that an organization must have in place to enhance client safety and minimize risk. Assessment Method On-site Criteria marked with On-Site means that the criteria will be assessed on-site by a third party evaluator. Attestation Criteria marked with Attestation means that the health services provider is required to attest that they are compliant with the criteria. These may be audited by the health services accreditor. 3
PLANNING AND DEVELOPING INFECTION PREVENTION AND CONTROL ACTIVITIES 1.0 Infection prevention and control activities are planned, developed, and supported based on organizational priorities, evidence, and best practices. 1.1 Infection prevention and control activities are planned and developed based on a risk assessment and organizational priorities. Infection prevention and control activities are tailored to the setting, the level and type of care being provided, and the risk to clients/residents, team members and volunteers if an infection occurs. Infection prevention and control activities include developing policies and procedures for routine practices and additional precautions, delivering infection prevention and control education, and the ongoing evaluation of infection rates. 1.2 Evidence and best practices on infection prevention and control are reviewed when planning and developing infection prevention and control activities. Evidence and best practices can be accessed through publications, presentations, and conferences. For a list of reference and resource documents that may be used for planning and developing infection prevention and control activities, see the reference list at the end of these standards. 1.3 The resources needed to support infection prevention and control activities are provided and are regularly reviewed to ensure they are adequate. 4
The resources needed to support infection prevention and control activities will depend on the size of the organization and the type of services it provides. Examples of resources for infection prevention and control include personal protective equipment, alcohol-based (or other alternative) hand rubs, hand-washing sinks, and cleaning solutions and disinfectants. 2.0 A collaborative approach is used to support infection prevention and control activities. 2.1 Responsibility for planning, developing, implementing, and evaluating infection prevention and control activities is assigned. Infection prevention and control activities may be coordinated by a team, committee, or individual, depending on the organization's size and needs. 2.2 Infection prevention and control is considered and input is gathered from infection prevention and control experts when planning and designing the physical environment, including any plans for construction and renovation. The organization is only responsible for areas that are under its control (e.g., offices, clinics, long-term care facilities). The organization is not responsible for the design of community spaces where team members may meet with clients/residents, although it may provide input if there are plans to renovate those spaces. When planning to build a new physical environment or renovate an existing one, infection prevention and control is taken into consideration. Considerations include crowding/space for clients/residents, number and location of washrooms, and the availability of hand-washing sinks. During construction, dust particles contaminated with bacteria or fungi can spread, thereby increasing the risk of infection. Precautions can be taken to reduce risk by identifying infectionrelated risks during construction and renovations (e.g., the spread of Aspergillus Legionnella), making plans for cleaning and disinfecting during and following the work, and instructing construction workers on the appropriate hand hygiene in a health care environment. 5
2.3 Optimal environmental conditions are maintained within the physical environment. Environmental conditions refers to temperature, humidity, air circulation, and water quality within the physical environment. The organization is only responsible for environmental conditions in areas that are under its control (e.g., offices, clinics, long-term care facilities). The organization is not responsible for the environmental conditions of clients' homes or community spaces where team members may meet with clients. Poor air quality can promote the transmission of microorganisms within the organization. For example, excessive humidity levels can increase microorganisms' survival rate on surfaces. Optimal environmental conditions are maintained throughout the organization, including in office spaces and supply areas. 2.4 Protocols are established for the safe handling of soiled linen where applicable. Team members handle soiled linen carefully to avoid transmitting microorganisms. Clean linen is transported separately from soiled linen and is stored in a manner that prevents contamination by dust, which may contain fungal spores. 2.5 Processes are established for selecting and handling medical devices and equipment. Medical devices and equipment are one of the key sources of health care-associated infections. When selecting medical devices, infection prevention and control is taken into consideration. For example, organizations may choose to select single-use devices if they are unable to reprocess the devices on-site. Handling medical devices and equipment includes safely transporting contaminated devices and equipment to a central area for reprocessing, and storing clean medical devices and equipment separately from contaminated devices and equipment. 2.6 Where food handling occurs, applicable standards for food safety are followed to prevent food-borne illnesses. 6
The proper storage, preparation, and handling of food are critical to preventing food-borne illness. Food storage, preparation and handling are monitored even if food is made using pre-prepared mixes or ingredients, or if the preparation is done off-site. Team members involved in food handling receive training regarding food safety. If volunteers participate in food handling and are not trained in food safety, they are supervised by someone who has received the training. Where food services are contracted to external providers, roles and responsibilities of the external contractor are defined, and the quality of the services it provides are verified. In some jurisdictions, food services are inspected by public health or the governing body responsible for agriculture. Areas for improvement identified by these regulatory authorities are followed-up on. 3.0 The organization collaborates with partners on infection prevention and control activities. 3.1 The organization partners with organizations in its community to implement infection prevention and control activities. Partners include public health agencies; local hospitals; peer organizations; organizations to which clients/residents are referred and from which clients/residents are received; professional associations; occupational health and safety bodies; and local, regional, and national governments. The extent of the organization's partnerships will depend on its size, mandate, and scope of services. 3.2 The organization works with its partners to develop a pandemic plan. 7
All health care settings must prepare for the possibility of pandemic (e.g., influenza pandemic). The type of preparation and plan will differ depending on the organization's size, services, and role. Organizations can coordinate with regional governments, public health, and other partners to prepare a plan for responding to a pandemic. The main goal of the plan will be to maintain services to clients/residents and to prevent the spread of the infection to clients/residents, families, team members, and volunteers, wherever possible. This plan may include education for clients/residents on how to protect themselves during a pandemic. The pandemic plan can be part of the organization's overall plan for disasters and emergencies. 8
IMPLEMENTING INFECTION PREVENTION AND CONTROL ACTIVITIES 4.0 Infection prevention and control policies and procedures are maintained based on applicable regulations, organizational priorities, evidence, and best practices. 4.1 A risk assessment is completed to identify activities that have a high risk for spreading infections, and the activities are addressed in infection prevention and control policies and procedures. Examples of high-risk activities include handling spills, specimens, and sharps; exposure to blood and body fluids; and exposure to contaminated waste. 4.2 There are policies and procedures that are in line with applicable regulations, evidence, and best practices, and organizational priorities. Policies and procedures are clear and concise. Topics include hand hygiene, work restrictions related to infection, aseptic techniques when handling injectable products, appropriate use of personal protective equipment, and handling contaminated items. Organizations seek input from clients/residents and families when developing policies andprocedures. 4.3 If sterile substances are prepared, handled, or administered, aseptic techniques are used while doing so, both within the preparation area and at the point of client/resident interaction. Examples of sterile substances include vaccines, parenterally administered medications, and total parenteral nutrition. The contamination of equipment, vaccines, medication, nutrition, or clients/residents, or team members can occur at multiple points during preparation and delivery. 4.4 There are policies and procedures for the use of loaned, shared, consigned, and leased medical devices, when applicable. 9
If loaned, shared, consigned, or leased medical devices are used, policies and procedures are developed to address their transport to and from the organization or another point of use (e.g., client's home), and to handle items that are delivered unclean or unsterilized, or incomplete (missing parts). 4.5 Infection prevention and control policies and procedures are made readily available to team members and volunteers. Policies and procedures are available in a written or electronic format and team members, and volunteers can easily access them. 4.6 Compliance with infection prevention and control policies and procedures is monitored and improvements are made to the policies and procedures based on the results. This includes a process for team members, volunteers, and clients/residents and families to provide feedback, and report noncompliance with policies and procedures to the person(s) responsible for infection prevention and control (e.g., Infection Prevention and Control Coordinator). Audit tools can be used to monitor compliance with policies and procedures. Some organizations perform flash audits, where they observe team members during their day-to-day work, but do not disclose which activities they are auditing. 4.7 Infection prevention and control policies and procedures are updated regularly based on changes to applicable regulations, evidence, and best practices. 5.0 Team members, clients/residents, families, and volunteers are engaged to promote an infection prevention and control culture within the organization. 5.1 A multi-faceted approach to promote infection prevention and control activities is used within the organization. 10
More than just traditional education methods are used to help increase compliance with routine practices and additional precautions for infection prevention and control. Examples include sending reminder emails to all team members, providing interactive education sessions, developing promotional videos, and delivering awareness campaigns. 5.2 Team members, clients/residents and families, and volunteers are engaged when developing strategies for promoting infection prevention and control activities. 5.3 There are comprehensive infection prevention and control education activities tailored to priorities, services, and client/resident populations. The infection prevention and control education covers policies and procedures, contact information for those responsible for infection prevention and control in the organization, and information about infection prevention and control that is specific to the organization's services and setting (e.g., infections frequently seen in that setting). Access to infection prevention and control resources is also provided, such as toolkits and webinars. 5.4 Information on how to safely perform high-risk activities is provided, including appropriately using personal protective equipment as outlined in policies and procedures. High-risk activities require the use of personal protective equipment appropriate to the task. Team members learn how to select personal protective equipment based on the type of exposure anticipated, durability, appropriateness, and fit. Team members also know when to wear, and how to wear, change, and remove the personal protective equipment appropriately. This information can be provided through education sessions and/or reminders that are posted or shared (e.g., via email) throughout the organization. 5.5 Team members and volunteers are required to receive infection prevention and control education at orientation and regularly thereafter based on their roles and responsibilities for infection prevention and control. 11
The organization may maintain a learning management system to track attendance at education sessions, identify necessary followup training, and identify individuals who are overdue for education. Client/resident and family representatives involved in the organization are also offered education at orientation. 5.6 The effectiveness of activities to promote infection prevention and control are evaluated regularly and improvements are made as needed. The activities are evaluated by asking team members for their input and using performance measures for routine practices and additional precautions. The information obtained from the evaluation can be used to improve compliance with infection prevention and control activities. For example, a hand-hygiene self-assessment may be completed, and a strategy developed to improve compliance with hand hygiene based on the results. 6.0 Clients/residents, families, and visitors are engaged in infection prevention and control practices. 6.1 Clients/residents, families, and visitors are provided with information about routine practices and additional precautions in a format that is easy to understand. Clients/residents and families play an important role in promoting infection prevention and control activities. Information may include the appropriate use of personal protective equipment, hand hygiene, and respiratory hygiene. Information is provided verbally and in writing. Written materials may be available in a variety of languages depending on the populations served. The language used is easy to understand, and may include visual cues to improve understanding. Written materials may include pamphlets or posters. 6.2 Clients/residents, families, and visitors are provided with information on how to access hand hygiene resources and personal protective equipment based on risk of infection. 12
Hand hygiene resources include hand-washing facilities and alcohol-based hand rubs. Based on the client's/resident's risk assessment for infection, the organization can provide advice and direction on supplies that would help to reduce the client's/resident's risk of infection, and may provide the supplies, where appropriate. 6.3 Clients/residents are screened to determine if additional precautions are required based on the risk of infection. Team members are trained to determine whether additional precautions are required to prevent the transmission of infection. Team members refer to the applicable infection prevention and control policies and procedures, and may need to involve the person responsible for infection prevention and control in the organization to complete the risk assessment. This information is documented in the client/resident record. 7.0 The occupational health and safety policies address organizational priorities for infection prevention and control. 7.1 There are occupational health and safety policies and procedures to reduce the risk of transmission of infections to team members and volunteers. The organization's policies and procedures are based on the health care setting, the level of care, and the level of risk of infection. Key safety precautions for team members include: having an immunization policy; providing access to appropriate personal protective equipment; promoting sharps safety; preventing exposure to blood-borne pathogens; and setting work restrictions if needed. 7.2 An immunization policy is developed or adopted that includes providing information to clients/residents and team members about how to access vaccinations. 13
Vaccination is a cost-effective method of preventing illness. Vaccinations that may be recommended to team members include tetanus, diphtheria, influenza, and hepatitis B. In some jurisdictions, specific vaccinations may be required. The immunization policy addresses how the organization will handle situations in which team members refuse immunization. In some jurisdictions, the organization follows the immunization policy set by government. 7.3 There are policies and procedures for using appropriate personal protective equipment. Team members have access to personal protective equipment as needed. Team members that require the use of a respirator (e.g., N95) are provided with regular (e.g., annual) fit testing. 7.4 Work restrictions are set for team members, volunteers, or students who have transmissible infections, in line with national, or regional occupational health and safety guidelines. Work restrictions prevent team members, volunteers, or students from having direct contact with clients/residents, food, or sterile supplies, devices, and equipment when they have a transmissible infection [e.g., acute conjunctivitis, acute respiratory infection, gastroenteritis with vomiting or diarrhea, varicella, scabies, impetigo, herpes zoster (shingles)]. Work restrictions may include limiting the person's roles and responsibilities, and/or having them wear personal protective equipment as appropriate. 7.5 Policies, procedures, and legal requirements are followed when handling bio-hazardous materials. 14
Examples of bio-hazardous materials include blood and body fluids, specimen cultures, used sharps, and animal waste. The appropriate handling including collection, storage, transportation, and disposal of bio-hazardous materials minimizes the risk of exposure to microorganisms. Equipment and devices that have been in contact with bodily fluids are considered to be contaminated and potentially infectious and are transported appropriately to a dedicated decontamination or disposal area. Applicable regulations and/or bylaws are followed when developing and implementing handling and disposal policies for bio-hazardous materials, including sharps. 7.6 There are policies and procedures for the disposal of sharps at the point of use in appropriate puncture-, spill-, and tamper-resistant sharps containers. Sharps include needles and blades. Applicable regulations provide guidance on safe and appropriate sharps disposal. Clients who use sharps in their homes (e.g., hypodermic needles) are advised how to dispose of them in accordance with applicable regulations. 7.7 Safety engineered devices for sharps are used. Safety engineered devices protect the user from exposure to biohazardous or chemical substances (e.g., blood-borne pathogens, cytotoxic medications). They have a built-in mechanism to protect the user from a sharps injury (e.g., needles that retract after use). In settings where clients/residents self-administer medications via injection, the organization can advise the use of safety engineered devices; however, clients/residents are not required to use them. 8.0 A comprehensive hand-hygiene strategy is in place. 8.1 Hand-hygiene education is provided to team members and volunteers. 15
Hand hygiene is critical to infection prevention and control programs, but adherence to accepted hand-hygiene protocols is often poor. It has been shown that the costs of health careassociated infections significantly exceed those related to implementing and monitoring hand-hygiene programs. Training on hand hygiene is multimodal and addresses the importance of hand hygiene in preventing the transmission of microorganisms, factors that have been found to influence handhygiene behaviour, and proper hand-hygiene techniques. Training also includes recommendations about when to clean one's hands, based on the four moments for hand hygiene: 1. Before initial contact with the client or their environment. 2. Before a clean/aseptic procedure. 3. After body fluid exposure risk. 4. After touching a client or their environment. Test(s) for Compliance 8.1.1 Team members and volunteers are provided with education about the hand-hygiene protocol. 8.2 There is a process to select and review products for hand hygiene, including alcohol-based hand rubs (or alternatives) and hand soaps. The process for selecting products includes seeking input from team members, and reviewing best practice guidelines. Alcohol-based hand rubs are preferred; however, in some settings, it may be appropriate to use a non-alcohol-based hand rub. 8.3 Team members,clients/residents, families, and volunteers have access to alcohol-based hand rubs (or alternatives) at the point of client/resident interaction. 16
The point of client/resident interaction may also be referred to as the point of care. Existing guidelines on hand hygiene in health care require that hand rubs be within one metre of where care is delivered. However, fire regulations or other considerations may limit the placement of alcohol-based hand rubs. Hand rubs are placed as close to the point of client/resident interaction as possible (e.g., in the client's/resident's room, at the bedside, carried by the team member, or directly in the client's home). The availability of hand hygiene resources in the service environment is audited. 8.4 Compliance with accepted hand-hygiene practices is measured. Hand hygiene is considered the single most important way to reduce health care-associated infections, but compliance with accepted hand-hygiene practices is often poor. Measuring compliance with hand-hygiene practices allows organizations to improve education and training about hand hygiene, evaluate hand-hygiene resources, and benchmark compliance practices across the organization. Studies show that improving compliance with hand-hygiene practices decreases health care-associated infections. Direct observation (audits) is the best method to measure compliance with hand-hygiene practices. This involves watching and recording the hand-hygiene behaviours of team members and observing the work environment. Observation can be done by a trained observer within an organization, by two or more health care professionals working together, or by clients and families in the organization or in the community. Ideally, direct observation measures compliance with all four of the moments for hand hygiene: 1. Before initial contact with the client or their environment 2. Before a clean/aseptic procedure 3. After body fluid exposure risk 4. After touching a client or their environment Direct observation should be used by all organizations working out of a fixed location (i.e., clients come to them). Organizations that provide services in clients' homes and find that direct observation is not possible may consider alternative methods. As these alternatives are not as robust as direct observation, they should be used in combination (two or more) to give a more accurate picture of compliance with hand-hygiene practices. 17
Test(s) for Compliance 8.4.1 Compliance with accepted hand-hygiene practices is measured using direct observation (audit). For organizations that provide services in clients' homes, a combination of two or more alternative methods may be used, for example: Team members recording their own compliance with accepted hand-hygiene practices (self-audit). Measuring product use. Questions on client satisfaction surveys that ask about team members' hand-hygiene compliance. Measuring the quality of hand-hygiene techniques (e.g., through the use of ultraviolet gels or lotions). 8.4.2 Hand-hygiene compliance results are shared with team members and volunteers. 8.4.3 Hand-hygiene compliance results are used to make improvements to hand-hygiene practices. 9.0 A clean and disinfected physical environment is maintained as appropriate to the setting, level of care provided, and risk of infection. 9.1 Areas of the physical environment are categorized based on the risk of infection to determine frequency of cleaning and the level of disinfection required. The organization is only responsible for cleaning areas that are under its control (e.g., offices, clinics, long-term care facilities). The organization is not responsible for the cleanliness of clients' homes or community spaces where team members may meet with clients. The physical environment may be divided into several areas depending on the risk of transmitting infections. The criteria used to identify these areas can include the level of client/resident traffic (e.g., waiting rooms, elevators, and mobile equipment), the type of activity performed (e.g., clinical or administrative), the type of clients/residents (e.g., those with an infectious disease or a compromised immune system), and the probability of being exposed to body fluid. 9.2 Roles and responsibilities are assigned for cleaning and disinfecting the physical environment. 18
Roles and responsibilities address those individuals most involved in cleaning and disinfecting the physical environment. They also address the roles and responsibilities of other team members, and volunteers in checking the cleanliness of the physical environment and reporting problems to the appropriate individual or group. 9.3 There are policies and procedures for cleaning and disinfecting the physical environment and documenting that cleaning has been done. The organization is only responsible for cleaning areas that are under its control (e.g., offices, clinics, long-term care facilities). The organization is not responsible for the cleanliness of clients' homes or community spaces where team members may meet with clients. Cleaning activities cover all surfaces within the organization with the primary focus on high-touch areas (areas that are frequently contacted by hands, such as doorknobs, bedrails, and light switches) in client/resident care areas. Cleaning activities cover cleaning walls, windows, and ceilings; cleaning toilets and commodes; removing waste; promptly cleaning and managing spills; and maintaining general tidiness. Documentation of cleaning activities includes the date and the choice of cleaning material or disinfectants used. When cleaning, areas are designated either as hotel clean, or health care clean (also referred to as hospital clean ). Hotel clean includes dust and dirt removal, waste disposal, and the cleaning of windows and surfaces. This level of cleaning takes place in all areas of a health care setting. Health care clean is maintained in areas that the client/resident touches, and includes all of the elements of hotel clean, as well as disinfection, more frequent cleaning, and the auditing of cleaning activities 9.4 There are policies and procedures for cleaning and disinfecting spaces used by clients/residents who are on additional precautions. The organization is only responsible for cleaning areas that are under its control (e.g., offices, clinics, long-term care facilities). The organization is not responsible for the cleanliness of clients' homes or community spaces where team members may meet with clients. 9.5 Compliance with policies and procedures for cleaning and disinfecting the physical environment is regularly evaluated, with input from clients/residents and families, and improvements are made as needed. 19
This may include client/resident and team surveys, visual assessments, and routine sample audits of the cleanliness of the physical environment. The evaluation results are documented and reviewed to identify areas for improvement, with input from team members. 9.6 When cleaning services are contracted to external providers, a contract is established and maintained with each provider. This contract requires consistent levels of quality and adherence to accepted standards of practice. 9.7 When cleaning services are contracted to external providers, the quality of the services provided is regularly monitored. For example, copies of reports and other documentation that demonstrate how the external provider monitors the quality of its services are reviewed. 10.0 The organization follows manufacturers' instructions and accepted standards of practice to clean, disinfect, and sterilize reusable medical devices and equipment. 10.1 For each contaminated device and piece of equipment, a recognized classification system is used to determine what level of disinfection or sterilization is required. 20
The Spaulding Classification System was developed to provide an approach for selecting the necessary level of disinfection and sterilization for medical devices based on how they are used. It is the most commonly used classification system of its type. The organization uses a classification system to identify critical, semi-critical, and non-critical items based on the use of the item and the risk of infection. Each classification has requirements for decontamination, cleaning, and disinfection or sterilization that reduce the risk of infection. Under the Spaulding Classification System: An item that only comes into contact with clients'/residents' intact skin (e.g., blood pressure cuffs, bedpans, and crutches) may be classified as noncritical and require low-level disinfection. Items that contact mucous membranes (e.g., respiratory therapy equipment) are considered semi-critical and require high-level disinfection. Those that enter sterile spaces or contact non-intact skin (e.g., foot care instruments) are critical devices and must be sterilized. The classification system clearly states that critical items may be used for non-critical activities or procedures, but non-critical items may not be used for critical activities or procedures. 10.2 A designated individual is accountable for quality oversight and for coordinating cleaning, disinfection, and sterilization of devices and equipment in the organization. The designated team member has the knowledge, training and competence to understand key issues in cleaning, disinfection, and sterilization of devices and equipment. Accountability is clearly written, e.g., reflected on an organization chart. The designated person reports directly to the organization's leadership team. In organizations with multiple sites or locations, the designated individual is accountable for cleaning, disinfection, and sterilization activities across all sites and locations. 10.3 Clear and concise policies and procedures are developed and maintained for cleaning, disinfecting, and sterilizing reusable medical devices. 21
The organization's policies and procedures for cleaning, disinfecting, and sterilizing reusable medical devices address all stages of the process (e.g., from disassembly of the device to reprocessing and re-assembly). The policies and procedures cover the following topics: Training and education Occupational health and safety The management and reporting of patient safety incidents Cleaning, disinfecting, and/or sterilizing devices or equipment according to their risk class and the manufacturers' instructions Cleaning, disinfecting, and sterilizing loaned, shared, consigned, or leased devices and equipment Special precautions for devices or equipment that are difficult to clean, disinfect, or sterilize Disassembly and reassembly of devices Functional testing of complex devices following reassembly Offsite transportation of medical devices (when applicable) Quality control Recall procedures Emergency procedures for various emergencies including sterilizer shutdowns, utility failures, or shutdowns 10.4 Required training, education, and experience are defined for all team members that participate in cleaning, disinfecting, and/or sterilizing medical devices and equipment. The required training, education, and experience will vary by role. It may be defined by a professional regulating body, may be formal or informal, and may include lived experience or work experience. Verifying the qualifications of staff involved in the reprocessing of medical devices/equipment is important in preventing the mishandling or improper reprocessing of these devices. 10.5 Current manufacturers' instructions are upheld when cleaning, disinfecting, or sterilizing medical devices and equipment. 10.6 Policies, procedures, and manufacturers' instructions are accessible to all team members. The instructions may be in written form (e.g., binders, manuals, or monographs) and/or in electronic format. Team members know where to access the instructions. 22
10.7 Cleaning, disinfection, and sterilization of critical and semi-critical single-use devices (SUD) is not permitted on-site, in line with the organization's policy and regional regulations. 10.8 If cleaning, disinfection, or sterilization of reusable medical devices and equipment is contracted to external providers, a written agreement or contract is maintained with each provider that outlines requirements and respective roles and responsibilities. The agreement requires that contracted service providers adhere to accepted standards of practice, and are monitoring the quality of reprocessing services. Examples include daily monitoring of printouts or electronic records, maintaining records of each sterilization cycle, and having a process to report issues with reprocessed devices (e.g. defective wraps or medical devices and equipment that arrive soiled). 10.9 When cleaning, disinfection, or sterilization of reusable medical devices and equipment is contracted to external providers, the organization regularly monitors the quality of the services provided. The organization verifies that the external provider follows accepted standards of practice to monitor the quality of services (e.g., daily monitoring of printouts and data, reporting systems, and mechanisms to report deficiencies). The organization reviews copies of reports and printouts and any other documentation demonstrating the quality monitoring performed by the external provider. 10.10 When cleaning, disinfection, and/or sterilization of medical devices or equipment is done in-house, team members involved in these processes are provided with education and training in how to do so when they are first employed and on an ongoing basis. Reprocessing includes the processes of cleaning, disinfection, and sterilization, and the level of reprocessing used depends on the risk of infection associated with the type of device/equipment. Training addresses the organization's reprocessing policies and procedures; information on cleaning, disinfection, and sterilization (as appropriate); occupational health and safety issues; and infection prevention and control issues related to reprocessing. 23
10.11 When an organization cleans, disinfects, and/or sterilizes devices and equipment in-house, there are designated and appropriate area(s) where these activities are done. The designated area(s) should have adequate space for cleaning and storage and be separate from areas where clean devices and equipment are handled or stored. The area(s) should be equipped with hand hygiene facilities, and air exchanges, temperature, and humidity should be appropriate to the activity and the cleaning products being used (refer to manufacturer's recommendations). Cleaning, disinfection, and sterilization done outside the designated area should be kept to a minimum. 10.12 Eating and drinking, food storage, cosmetics application, and contact lens handling are all prohibited in the area where cleaning, disinfection, and/or sterilization of medical devices and equipment are done. 10.13 Items that require cleaning, disinfection, and/or sterilization are safely contained and transported to the appropriate area(s). Cleaning, disinfection, and/or sterilization may be done in the organization or at another site or be outsourced to a private company. Used medical devices and equipment should be considered to be contaminated. When transporting contaminated equipment and devices, applicable regulations are followed, environmental conditions are controlled, and clean and appropriate bins, boxes, bags, and transport vehicles are used. Contaminated items are transported separately from clean items, and away from care delivery areas and high-traffic areas. 10.14 Appropriate personal protective equipment is worn when cleaning, disinfecting, or sterilizing medical devices and equipment. Depending upon the task, the appropriate personal protective equipment may include gloves that are appropriate to the task; a fluid-resistant cover garment with sleeves (e.g. backless gown, jumpsuit, or surgical gown); and a full face shield or a fluidimpervious face mask to fully protect eyes, nose and mouth. 24
10.15 Contaminated devices and equipment are cleaned before further disinfection or sterilization is done. Devices and equipment that have been used should be considered to be contaminated. Cleaning is essential before disinfection or sterilization. If an item is not cleaned, soil, such as blood, body fluids, or dirt, can protect microorganisms from disinfection and sterilization processes, or can inactivate the disinfectant so it will not work. 10.16 Detergents, solutions, sterilants, and disinfectants selected are in line with manufacturers' instructions, and are compatible with the devices being cleaned, disinfected, or sterilized, and with the equipment and processes for cleaning, disinfection, or sterilization. All disinfectants have a unique identifier. Others in the organization may need to be consulted (e.g. infection prevention and control, or occupational health and safety) when selecting appropriate detergents or disinfectants. 10.17 For each detergent, solution, sterilant, and disinfectant, manufacturers' instructions for use are followed. Manufacturers' instructions address topics such as ventilation requirements, contact time, shelf life, storage requirements, appropriate dilution, how to test the concentration and effectiveness, and the appropriate personal protective equipment to wear when handling the detergent, solution, sterilant or disinfectant. 10.18 Each device or set of devices that are intended for sterilization are prepared according to manufacturers' instructions. 10.19 When devices are being sterilized, an internal chemical indicator is placed in each package or container, according to the organization's quality control processes, to verify that sterilizer penetration has occurred. 10.20 Sterilized packages are clearly identifiable and distinguished from non-sterilized items. 25
This helps prevent the release and use of non-sterilized medical devices. 10.21 The integrity of each sterile package is maintained. Items that have been properly decontaminated, wrapped, sterilized, stored, and handled will remain sterile indefinitely, unless the integrity of the package is compromised. The integrity of the package is based on: the type of wrapper used; the method of sealing the package; the type of shelving used, including open or closed; the method and frequency of handling; the method, frequency, and conditions of transportation and distribution; the environmental conditions of the storage area, e.g. temperature, humidity, ventilation, cleanliness; and, control and monitoring of access to storage areas. 10.22 There is a process that allows for the tracking of medical devices associated with a sterilizer or sterilization cycle. The record includes information that may be required for a recall action. Instruments, devices, and supplies could be recalled for a variety of reasons, such as when sterilization activities fail. 10.23 Processes for cleaning, disinfecting, and sterilizing medical devices and equipment are monitored and improvements are made when needed. 26
The processes of cleaning, disinfecting, and sterilizing are collectively known as reprocessing, and the level of reprocessing depends on the risk of infection (according to the Spaulding classification). Organizations reprocess equipment based on the Spaulding classification and according to manufacturers' instructions. Monitoring reprocessing helps to identify areas for improvement and reduce health care-associated infections. The effectiveness of cleaning and disinfection can be measured by monitoring: water quality and washer function, whether appropriate concentrations of disinfectants are available, and whether disinfectants are used according to manufacturers' instructions. The effectiveness of sterilization can be monitored by measuring organic residuals, ATP (adenosine triphosphate), and total viable count; and by using test strips to confirm that devices/equipment are sterilized. If the organization does not reprocess equipment, it has a process to ensure equipment has been appropriately reprocessed prior to use. Test(s) for Compliance 10.23.1 There is evidence that processes and systems for cleaning, disinfection, and sterilization are effective. 10.23.2 Action has been taken to examine and improve processes for cleaning, disinfection, and sterilization where indicated. 27
EVALUATING THE IMPACT OF INFECTION PREVENTION AND CONTROL ACTIVITIES 11.0 A plan is in place to monitor infections among clients/residents appropriate to the type of setting, the level of care provided, and the risk of infection. 11.1 There is an infection monitoring plan that is in line with applicable regulations, evidence and best practices, and organizational priorities. Infections can spread quickly among clients/residents, team members, and volunteers even those working in the community. To help prevent the spread of infections, the organization should be aware of infections among clients/residents, team members, and volunteers, and monitor any spread of infections among these groups. The infection monitoring plan will vary depending on its setting, the level of care provided, and the risk of infection. For example, clients/residents in long-term care or rehabilitation settings who require complete assistance with daily living activities and who may have urinary catheters, feeding tubes, wounds, or incontinence, have a higher risk of infection compared to settings where clients/residents do not. The results of monitoring programs can be used to respond to outbreaks, and to make improvements to infection prevention and control activities, for example, by investing in additional resources, updating policies and procedures, and reviewing educational programs. 11.2 Health care-associated infections are tracked, information is analyzed to identify outbreaks and trends, and this information is shared throughout the organization. NOTE: This ROP only applies to organizations that have beds and provide nursing care. 28
The health care-associated infections most common to the organization's services and client populations are identified and tracked. These could include Clostridium difficile (C. difficile), surgical site infections, seasonal influenza, noroviruses, urinary tract infections, and other reportable diseases and antibioticresistant organisms. Tracking methods for health care-associated infections may focus on a particular infection or service area or may be organization- or system-wide. They may include data analysis techniques to help detect previously unrecognized outbreaks. Tracking may include frequencies and changes in frequencies over time, associated mortality rates, and attributed costs. Teams that are well informed about health care-associated infection rates are better equipped to prevent and manage them. The role or position responsible for receiving information about health care-associated infection rates is identified and a plan is established to regularly disseminate information (e.g., quarterly reports to all departments). In addition to team members, the governing body needs to be informed about health care-associated infection rates and associated infection prevention and control issues. This may be done directly through senior management or a medical advisory committee. Test(s) for Compliance 11.2.1 Health care-associated infection rates are tracked. 11.2.2 Outbreaks are analyzed and recommendations are made to prevent recurrences. 11.2.3 Information about relevant health care-associated infections and recommendations from outbreak reviews are shared with team members, senior leadership, and the governing body. 11.3 There is a process to promptly detect suspected health careassociated infections among clients/residents. Methods of detecting health care-associated infections may be passive (e.g., identified during the course of routine service delivery), or active (e.g., detected by trained professionals using planned monitoring). Voluntary reporting by team members, clients/residents, and volunteers is promoted, and additional methods are used to detect infections, such as active identification, automated methods of detection, or centralized identification through the microbiology laboratory. 29
11.4 Those responsible for receiving and responding to information on suspected health care-associated infections among clients/residents are identified. Team members, clients/residents, families, and volunteers know to whom they must report information about infections. 11.5 The source or cause of health care-associated infections is investigated. Sources of infection can include contaminated or spoiled food, direct physical contact with an infected person, contact with an item that has been contaminated, or air-borne microorganisms (e.g., from a contaminated air conditioning system). The investigation process includes identifying all the possible causes of the infection and prioritizing and addressing those that are likely to be the source. 11.6 Infection prevention and control or public health experts are consulted with to control health care-associated infections, and the necessary information is reported to the appropriate authorities in line with the applicable regulations. Experts may include medical microbiologists, nurses, and other professionals.certain health care-associated infections must be reported in terms of frequency and location to authorities such as public health agencies. Reporting requirements vary per jurisdiction. 11.7 The results of investigations are used to improve programs, policies, or procedures, so as to prevent health care-associated infections from recurring. 12.0 The organization collaborates with other organizations to respond to outbreaks among clients/residents or in the community served. 12.1 There are policies and procedures for identifying and responding to outbreaks; and these are in line with the applicable regulations. 30