F880
§483.80 Infection Control
The facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.
§483.80(a) Infection prevention and control program.
The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:
§483.80(a)(1) A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to §483.71 and following accepted national standards;
§483.80(a)(2) Written standards, policies, and procedures for the program, which must include, but are not limited to:
(i) A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;
(ii) When and to whom possible incidents of communicable disease or infections should be reported;
(iii) Standard and transmission-based precautions to be followed to prevent spread of infections;
(iv) When and how isolation should be used for a resident; including but not limited to:
(A) The type and duration of the isolation, depending upon the infectious agent or organism involved, and
(B) A requirement that the isolation should be the least restrictive possible for the resident under the circumstances.
(v) The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and
(vi) The hand hygiene procedures to be followed by staff involved in direct resident contact.
§483.80(a)(4) A system for recording incidents identified under the facility’s IPCP and the corrective actions taken by the facility.
§483.80(e) Linens. Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.
§483.80(f) Annual review. The facility will conduct an annual review of its IPCP and update their program, as necessary.
INTENT §483.80(a)(1), (a)(2), (a)(4), (e) and (f)
The intent of this regulation is to ensure that the facility:
• Develops and implements an ongoing infection prevention and control program (IPCP) to prevent, recognize, and control the onset and spread of infection to the extent possible and reviews and updates the IPCP annually and as necessary. This would include revision of the IPCP as national standards change;
• Establishes facility-wide systems for the prevention, identification, reporting, investigation and control of infections and communicable diseases of residents, staff, and visitors. It must include an ongoing system of surveillance designed to identify possible communicable diseases and infections before they can spread to other persons in the facility and procedures for reporting possible incidents of communicable disease or infections. NOTE: For purposes of this guidance, “staff” includes all facility staff (direct and indirect care functions), contracted staff, consultants, volunteers, others who provide care and services to residents on behalf of the facility, and students in the facility’s nurse aide training programs or from affiliated academic institutions.
• Develops and implements written policies and procedures for infection control that, at a minimum:
o Define standard precautions to prevent the spread of infection and explain their application during resident care activities;
o Define transmission-based precautions and explain how and when they should be utilized, including but not limited to, the type and duration of precautions for particular infections or organisms involved and that the precautions should be the least restrictive possible for the resident given the circumstances and the resident’s ability to follow the precautions;
o Prohibit staff with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and
o Require staff to follow hand hygiene practices consistent with accepted standards of practice.
• Requires staff to handle, store, process, and transport all linens and laundry in accordance with accepted national standards in order to produce hygienically clean laundry and prevent the spread of infection to the extent possible.
DEFINITIONS
• “Airborne precautions” refer to actions taken to prevent or minimize the transmission of infectious agents/organisms that remain infectious over long distances when suspended in the air. These infectious particles can remain suspended in the air for prolonged periods of time and can be carried on normal air currents in a room or beyond, to adjacent spaces or areas receiving exhaust air.1
• “Alcohol-based hand rub (ABHR)” refers to a 60-95 percent ethanol or isopropyl alcohol-containing preparation base designed for application to the hands to reduce the number of viable microorganisms.
• “C. difficile infection (CDI)” refers to an infection from a bacterium that causes colitis, an inflammation of the colon, causing diarrhea.
• “Cleaning” refers to removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and is normally accomplished manually or mechanically using water with detergents or enzymatic products.
• “Cohorting” refers to the practice of grouping residents infected or colonized with the same infectious agent together to confine their care to one area and prevent contact with susceptible residents (cohorting residents).2 During outbreaks, healthcare staff may be assigned to a specific cohort of residents to further limit opportunities for transmission (cohorting staff). The term “cohort” or “cohorting” is standardized language used in the practice of infection prevention and control; the use of this terminology is not intended to offend residents or staff.
• “Colonization” refers to the presence of microorganisms on or within body sites without detectable host immune response, cellular damage, or clinical expression. 3
• “Communicable disease (also known as (a.k.a.) “contagious disease”)” refers to an infection transmissible (e.g., from person-to-person) by direct contact with an affected individual or the individual's body fluids or by indirect means (e.g., contaminated object).
• “Community-acquired infections (a.k.a. ‘present on admission’)” refer to infections that are present or incubating at the time of admission and which generally develop within 72 hours of admission.
• “Contact precautions” refer to measures that are intended to prevent transmission of infectious agents which are spread by direct or indirect contact with the resident or the resident’s environment.4
• “Contaminated laundry” refers to laundry which has been soiled with blood/body fluids or other potentially infectious materials or may contain sharps.
• “Decontamination” refers to the use of physical or chemical means to remove, inactivate, or destroy pathogenic organisms on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.
• “Disinfectant” refers to usually a chemical agent (but sometimes a physical agent) that destroys disease-causing pathogens or other harmful microorganisms but might not kill bacterial spores. It refers to substances applied to inanimate objects.5
• “Disinfection” refers to thermal or chemical destruction of pathogenic and other types of microorganisms. Disinfection is less lethal than sterilization because it destroys most recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores). 6
• “Droplet precautions” refer to actions designed to reduce/prevent the transmission of pathogens spread through close respiratory or mucous membrane contact with respiratory secretions.
* “Enhanced Barrier Precautions” (EBP) refer to an infection control intervention designed to reduce transmission of multidrug-resistant organisms that employs targeted gown and glove use during high contact resident care activities.
• “Hand hygiene” refers to a general term that applies to hand washing, antiseptic handwash, and alcohol-based hand rub.7
• “Hand washing” refers to washing hands with soap and water.8
• “Healthcare-associated infection (HAI)” refers to an infection that residents acquire, that is associated with a medical or surgical intervention (e.g., podiatry, wound care debridement) within a nursing home and was not present or incubating at the time of admission.
• “Hygienically clean” refers to being free of pathogens in sufficient numbers to cause human illness.9
• “Infection” refers to the establishment of an infective agent in or on a suitable host, producing clinical signs and symptoms (e.g., fever, redness, heat, purulent exudates, etc.).
• “Infection preventionist” refers to the person(s) designated by the facility to be responsible for the infection prevention and control program as specified in §483.80(b) (F882).
• “Legionellosis” refers to two clinically and epidemiologically distinct illnesses: Legionnaires’ disease, which is typically characterized by fever, myalgia, cough, and clinical or radiographic pneumonia; and Pontiac fever, a milder illness without pneumonia (e.g., fever and muscle aches). Legionellosis is caused by Legionella bacteria.
• “Multidrug-resistant organisms (MDROs)” refer to microorganisms, predominantly bacteria that are resistant to one or more classes of antimicrobial agents. Although the names of certain MDROs describe resistance to only one agent, these pathogens are frequently resistant to most available antimicrobial agents.
• “Personal protective equipment (PPE)” refers to protective items or garments worn to protect the body or clothing from hazards that can cause injury and to protect residents from cross-transmission.
• “Standard precautions” refer to the infection prevention practices that apply to all residents, regardless of suspected or confirmed diagnosis or presumed infection status. Standard precautions are based on the principle that all blood, body fluids, secretions, excretions except sweat, regardless of whether they contain visible blood, non-intact skin, and mucous membranes may contain transmissible infectious agents. Furthermore, equipment or items in the resident’s environment likely to have been contaminated with infectious body fluids must be handled in a manner to prevent transmission of infectious agents. Standard precautions include hand hygiene, proper selection and use of personal protective equipment, safe injection practices, respiratory hygiene/cough etiquette, environmental cleaning and disinfection, and reprocessing of reusable resident medical equipment.10, 11
• “Transmission-based precautions (a.k.a. “Isolation Precautions”)” refer to actions (precautions) implemented in addition to standard precautions that are based upon the means of transmission (airborne, contact, and droplet) in order to prevent or control infections. NOTE: Although the regulatory language refers to “isolation,” the nomenclature widely accepted by the healthcare community and used in this guidance will refer to “transmission-based precautions” instead of “isolation” as these terms can be used interchangeably.
NOTE: References to non-CMS sources are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services. CMS is not responsible for the content of pages found at these sites. URL addresses and referenced documents were current as of the date of this publication. Guidelines change, and facilities are responsible for following the most current standards.
GUIDANCE §§483.80(a)(1), (a)(2), (a)(4), (e), and (f)
Infection Prevention and Control Program
Healthcare-associated infections (HAIs) can cause significant pain and discomfort for residents in nursing homes and can have significant adverse consequences. The facility must establish and maintain an IPCP designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections. This program must include, at a minimum, a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, and visitors. The IPCP must follow accepted national standards and guidelines.
We expect facilities to tailor the emphasis of their IPCP for visitors and to work to prevent transmission of infection to the resident from the visitor using reasonable precautions and national standards.12 For example, “screening may be passive through the use of signs to alert family members and visitors with signs and symptoms of communicable diseases not to enter. More active screening may include the completion of a screening tool or questionnaire which elicits information related to recent exposures or current symptoms. That information is reviewed by the facility staff and the visitor is either permitted to visit or is excluded.”13
The Infection Prevention and Control Program must include, at a minimum, the following parts:
• A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases that:
o Covers all residents, staff, contractors, consultants, volunteers, visitors, others who provide care and services to residents on behalf of the facility, and students in the facility’s nurse aide training programs or from affiliated academic institutions;
o Is based on the individual facility assessment conducted under §483.71; and
o Follows accepted national standards.
• Written standards, policies and procedures in accordance with §483.80(a)(2);
• A system for recording incidents identified under the IPCP and corrective actions taken by the facility; and
• An antibiotic stewardship program (ASP) pursuant to §483.80(a)(3) (for more information on ASP requirements, see F881).
Facility Assessment
Pursuant to §483.71 (F838), the facility must conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies. The facility must review and update that assessment, as necessary, and at least annually. The facility must also review and update this assessment whenever there is, or the facility plans for, any change that would require a substantial modification to any part of this assessment. The facility assessment must address or include, among other things, a facility-based and community-based risk assessment, utilizing an all-hazards approach. See §483.71 (F838) for guidance on the facility assessment. The results of the facility assessment must be used, in part, to establish and update the IPCP, its policies and/or protocols to include a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for residents, staff, and visitors.
NOTE: A community-based risk assessment should include review for risk of infections (e.g., multidrug-resistant organisms/MDROs) and communicable diseases such as tuberculosis and influenza. Appropriate resident tuberculosis screening should be performed based on state requirements.
NOTE: While not required for compliance, a sample tool of an infection control risk assessment is available for adaptation.14
Infection Control Policies and Procedures
The facility must develop and implement written policies and procedures for the provision of infection prevention and control. The facility administration and medical director should ensure that current infection control standards of practice based on recognized guidelines and facility assessment are incorporated in the resident care policies and procedures. These IPCP policies and procedures must include, at a minimum, the following:
• As necessary, and at least annually, review and revision of the IPCP based upon the facility assessment (according to 483.71) which includes any facility and community risk;
• An ongoing system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;
• When and to whom possible incidents of communicable disease or infections should be reported within the facility;
• Which communicable diseases are reportable to local/state public health authorities;
• Define and explain standard precautions and their application during resident care activities. Define transmission-based precautions (i.e., contact precautions, droplet precautions, airborne precautions) and explain how and when they should be utilized, as consistent with accepted national standards. The areas listed below are examples of standard and/or transmission-based precautions15 which are further described under their respective sections:
o Hand hygiene (HH) (e.g., hand washing and/or ABHR): consistent with accepted standards of practice such as the preferential use of ABHR instead of soap and water in most clinical situations except when hands are visibly soiled 16 (e.g., blood, body fluids), or after caring for a resident with known or suspected C. difficile or norovirus infection during an outbreak, or if rates of C. difficile infection (CDI) are high; in these circumstances, soap and water should be used;17
NOTE: According to the Centers for Disease Control and Prevention (CDC),
strict adherence to glove use is the most effective means of preventing hand contamination with C. difficile spores as these spores are not killed by ABHR and may be difficult to remove even with thorough hand washing. Additional information on appropriate hand hygiene practices may be found in CDC’s Hand Hygiene in Healthcare Settings website at http://www.cdc.gov/handhygiene/providers/index.html;
o The selection and use of PPE (e.g., indications, donning/doffing procedures) and the clinical conditions for which specific PPE should be used (e.g., CDI, influenza);
o Addressing the provision of facemasks for residents with new respiratory symptoms;
o Addressing resident room assignment (e.g. single/private room/cohorted) as appropriate and/or available, based on a case by case analysis of the presence of risk factors for increased likelihood of transmission (e.g., uncontained drainage, stool incontinence);18
o The process to manage a resident on transmission-based precautions when a single/private room is not available;
o Limiting the movement of a resident who is on transmission-based precautions to medically necessary purposes only;19
o Respiratory Hygiene/Cough Etiquette: implementing policies and procedures would include providing resources and instructions for performing HH in or near lobby areas or entrances in accordance with accepted national standards. During times of increased prevalence of respiratory infections in the community, facilities should have facemasks available and offer them to visitors and others entering the facility. In addition, the facility should post signs with instructions on visitation restrictions for those with symptoms of respiratory infection or other communicable diseases;20 and
o Environmental cleaning and disinfection:
Routine cleaning and disinfection of frequently touched or visibly soiled surfaces in common areas, resident rooms, and at the time of discharge; and
NOTE: Privacy curtains should be changed when visibly dirty and should be laundered or disinfected with an Environmental Protection Agency (EPA)-registered disinfectant per the curtain and disinfectant manufacturer’s instructions.
Routine cleaning and disinfection of resident care equipment including equipment shared among residents (e.g., blood pressure cuffs, rehabilitation therapy equipment, blood glucose meters, etc.).
• Written occupational health policies that should address:
o Reporting of staff illnesses and following work restrictions per nationally recognized standards and guidelines;21, 22
o Prohibiting contact with residents or their food when staff have potentially communicable diseases or infected skin lesions;
o Assessing risks for tuberculosis (TB) based on exposure or cases of TB in the facility. Then screen staff for TB to the extent permitted under applicable federal guidelines23 and state law;
o Monitoring and evaluating for clusters or outbreaks of illness among staff; and
o Implementing an exposure control plan in order to address potential hazards posed by blood and body fluids (e.g., from dialysis, glucose monitoring or any other point of care testing).
• Facilities must ensure staff follow the IPCP’s standards, policies and procedures. Knowledge and skills pertaining to the IPCP’s standards, policies and procedures are needed by all staff in order to follow proper infection control practices (e.g., hand hygiene and appropriate use of PPE) while other needs are specific to particular roles, responsibilities, and situations (e.g., injection safety and point of care testing); and
• Residents and their representatives should receive education on the facility’s IPCP as it relates to them (e.g., hand hygiene, cough etiquette) and to the degree possible/consistent with the resident’s capacity. For example, residents should be advised of the IPCP’s standards, policies and procedures regarding hand hygiene before eating and after using the restroom.
Surveillance
The facility must establish a system for surveillance based upon national standards of practice and the facility assessment, including the resident population and the services and care provided. The facility must establish routine, ongoing, and systematic collection, analysis, interpretation, and dissemination of surveillance data to identify infections (i.e., HAI and community-acquired), infection risks, communicable disease outbreaks, and to maintain or improve resident health status. As part of the system of surveillance, the facility should determine how it will track the extent to which staff are following the facility’s IPCP policies and procedures, and facilities should address any areas that need corrective action.
The facility’s surveillance system must include a data collection tool and the use of nationally-recognized surveillance criteria, such as but not limited to, the CDC’s National Healthcare Safety Network (NHSN) Long Term Care Criteria to define infections or updated McGeer criteria.24 Furthermore, the facility must know when and to whom to report communicable diseases, healthcare-associated infections (as appropriate), and potential outbreaks (e.g., list of communicable diseases which are reportable to local/state public health authorities). The facility must document follow-up activity in response to
important surveillance findings (e.g., outbreaks).
In addition, the facility must establish and implement a system, including who to notify (e.g., infection preventionist), for early detection and management of a potentially infectious, symptomatic resident at the time of admission. This includes the identification and use of appropriate transmission-based precautions.25 This is important to incorporate into the resident’s baseline care plan that must be developed within 48 hours of admission and include the minimum healthcare information necessary to properly care for a resident, including physician orders (e.g., medication orders). See §483.21, Comprehensive Person-Centered Care Planning for further information.
Furthermore, the facility must have a process for communicating information at the time of transfer (e.g., CDC, state, or other standardized inter-facility infection transfer form) when a resident has an infection or is colonized.26 When a resident is transferred, the information provided to the receiving provider must include special instructions or precautions (e.g., transmission-based precautions, if applicable) for ongoing care and other necessary information including a discharge summary (if discharged). When a resident is discharged, the discharge summary must include the resident’s disease diagnoses and health conditions, course of illness/treatment or therapy, medications, and pertinent lab, radiology, consultation results, and instructions or precautions for ongoing care. See §483.21(c)(2)(iii), Discharge Process, Information provided to the receiving provider and §483.15(c)(2), Discharge Summary at (F628) T for further information on these requirements.
Additionally, as part of the overall IPCP for surveillance, the facility shall establish process and outcome surveillance.
Process Surveillance
Process surveillance is the review of practices by staff directly related to resident care.27 The purpose is to identify whether staff implement and comply with the facility’s IPCP policies and procedures. Some areas that facilities may want to consider for process surveillance are the following:
• Hand hygiene;
• Appropriate use of personal protective equipment (e.g., gowns, gloves, facemask);
• Injection safety;
• Point-of-care testing (e.g., during assisted blood glucose monitoring);
• Implementation of infection control practices for resident care such as but not limited to urinary catheter care, wound care, injection/IV care, fecal/urinary incontinence care, skin care, respiratory care, dialysis care, and other invasive treatments;
• Managing a bloodborne pathogen exposure. NOTE: This may not lend itself to monitoring and feedback;
• Cleaning and disinfection products and procedures for environmental surfaces and equipment (e.g., objective methods for evaluation may include direct practice observation, fluorescent markers, adenosine triphosphate (ATP) bioluminescence
(a method for quantifying the concentration of environmental microorganisms), or swab cultures used primarily for outbreak investigation28);
• Appropriate use of transmission-based precautions; and
• Handling, storing, processing, and transporting linens so as to prevent the spread of infection.
Outcome Surveillance
Another component of a system of identification is outcome surveillance. For example, this addresses the criteria that staff would use to identify and report evidence of a suspected or confirmed HAI or communicable disease. This process consists of collecting/documenting data on individual resident cases and comparing the collected data to standard written definitions (criteria) of infections.
NOTE: Additional information related to examples of nationally accepted surveillance definitions may be found at the “CDC/SHEA Position Statement: Surveillance Definitions of Infections in Long-Term Care Facilities: Revisiting the McGeer Criteria29” or NHSN at https://www.cdc.gov/nhsn/.
The following are some sources of data that can be utilized in outcome surveillance for infections, and antibiotic use and susceptibility:
• Monitoring a resident(s) with fever or other signs or symptoms suspicious for infection;
• Laboratory cultures or other diagnostic test results consistent with potential infections to detect clusters, trends, or susceptibility patterns;
• Antibiotic orders;
• Medication regimen review reports;
• Documentation from the clinical record of residents with suspicion of an infection such as physician orders/progress notes; and/or
• Transfer/discharge summaries for new or readmitted residents for infections.30
System of Surveillance: Data Analysis, Documentation and Reporting
The facility’s policies and procedures for a system of surveillance must include data to properly identify possible communicable diseases or infections before they spread. Therefore, the policies and procedures would include identifying:
• Data to be collected, including how often and the type of data to be documented, including:
o The infection site (i.e., type of infection), pathogen (if available), signs and symptoms, and resident location, including summary and analysis of the number of residents (and staff, if applicable) who developed infections;
o Observations of staff including the identification of ineffective practices (e.g., not practicing hand hygiene and/or using PPE when indicated as well as
practices that do not follow the facility’s IPCP policies and procedures), if any; and
o The identification of unusual or unexpected outcomes (e.g. foodborne outbreak), infection trends and patterns.
• How the data will be used and shared with appropriate individuals (e.g., staff, medical director, director of nursing, quality assessment and assurance committee- QAA), when applicable, to ensure that staff minimize spread of the infection or disease (e.g., require revision of staff education and competency assessment).
The facility must identify how reports will be provided to staff and/or prescribing practitioners in order to revise interventions/approaches and/or re-evaluate medical interventions related to the infection rates and outcomes.
Recognizing, Containing and Reporting Communicable Disease Outbreaks
The facility must know how to recognize and contain infectious disease outbreaks. An outbreak is the occurrence of more cases of disease than expected in a given area or among a specific group of people over a particular period of time.31 If a condition is rare or has serious health implications, an outbreak may involve only one case. While a single case of a rare infectious condition or one that has serious health implications may or may not constitute an outbreak, facilities should not wait for the definition of an outbreak to act. For example, one case of laboratory confirmed influenza in a resident should alert the facility to begin an outbreak investigation. If an outbreak is identified, the facility must:
• Take the appropriate steps to diagnose and manage cases, implement appropriate precautions, and prevent further transmission of the disease as well as documentation of follow-up activity in response; and
• Comply with state and local public health authority requirements for identification, reporting, and containing communicable diseases and outbreaks.
NOTE: Some states have specific regulations regarding responding to and reporting outbreaks that must be included in the IPCP.
NOTE: If there are concerns that actions taken by the facility are not addressing public health authority instructions to contain and remedy the outbreak, the SA must notify the appropriate local/state public health authority. If surveyors cite this tag for an outbreak, utilize the guidelines in Appendix Q to determine if immediate jeopardy exists.
Water Management
The bacterium Legionella can cause a serious type of pneumonia called Legionnaires’ Disease in persons at risk, such as those who are at least 50 years old, smokers, or with
underlying medical conditions such as chronic lung disease or immunosuppression. Legionella can grow in parts of building water systems that are continually wet (e.g., pipes, faucets, water storage tanks, decorative fountains), and certain devices can spread contaminated water droplets via aerosolization.
Legionellosis outbreaks are generally linked to locations where water is held or accumulates and pathogens can reproduce, including those found in long-term care facilities. Transmission from these water systems to humans occurs when the water is aerosolized (i.e., converted into a spray/mist in the air). Legionella is less commonly spread by aspiration of drinking water or ice.
Facilities must be able to demonstrate its measures to minimize the risk of Legionella and other opportunistic pathogens in building water systems such as by having a documented water management program. Water management must be based on nationally accepted standards (e.g., ASHRAE (formerly the American Society of Heating, Refrigerating, and Air Conditioning Engineers), CDC, U.S. Environmental Protection Agency or EPA) and include:
• An assessment to identify where Legionella and other opportunistic waterborne pathogens (e.g., Pseudomonas, Acinetobacter) could grow and spread; and
• Measures to prevent the growth of opportunistic waterborne pathogens (also known as control measures), and how to monitor them.
Examples of an assessment include a description of the building water systems using text and flow diagrams for identification. Additionally, control measures may include visible inspections, use of disinfectant, and temperature (that may require mixing valves to prevent scalding). Monitoring such controls include testing protocols for control measures, acceptable ranges, and documenting the results of testing. Water management should also include established ways to intervene when control limits are not met.
An industry standard calling for the development and implementation of water management programs in large or complex building water systems to reduce the risk of legionellosis was published by ASHRAE. The CDC and its partners developed a toolkit to facilitate implementation of this ASHRAE Standard.
Resources are available to develop and implement a water management program, such as:
• “The ASHRAE Standard 188- Legionellosis: Risk Management for Building Water Systems” https://www.ashrae.org;
• The CDC toolkit to facilitate implementation of the ASHRAE Standard titled “Developing a Water Management Program to Reduce Legionella Growth & Spread in Buildings: A Practical Guide to Implementing Industry Standards” https://www.cdc.gov/legionella/wmp/toolkit/index.html; and
• The EPA's “Technologies for Legionella Control in Premise Plumbing Systems: Scientific Literature Review” is available at https://www.epa.gov/ground-water-and-drinking-water/technologies-legionella-control-premise-plumbing-systems.
At this time, CMS does not require water cultures for Legionella or other opportunistic waterborne pathogens as part of routine program validation, although there may be instances when it is needed (e.g., a case of healthcare-associated legionellosis or a potential outbreak of legionellosis in the facility).
The facility should contact the local/state public health authority if there is a case of healthcare-associated legionellosis or an outbreak of an opportunistic waterborne pathogen causing disease. The facility must follow public health authority recommendations which may include, but is not limited to, remediating the pathogen reservoir and adjusting control measures as necessary. The SA should work with local/state public health authorities, if possible, to determine if the water management program was inadequate to prevent the growth of Legionella or other opportunistic waterborne pathogens and whether the facility implemented adequate prevention and control measures once the issue was identified.
Prevention and Control of Transmission of Infection
Infectious organisms (e.g., bacteria, viruses, or parasites) may be transmitted by direct contact (e.g., skin-to-skin) or indirect contact (e.g., inanimate objects). Healthcare staff and resident care equipment often move from resident to resident and therefore may serve as a vehicle for transferring infectious organisms.
Direct Contact Transmission (Person-to-Person) occurs when microorganisms such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), carbapenem-resistant Enterobacteriaceae (CRE), influenza, or mites from a scabies-infected resident are transferred from an infected or colonized person to another person. In nursing homes, resident-to-resident direct contact transmission may occur in common areas of the facility such as the recreation room, rehabilitation area, and/or dining room.
Indirect Contact Transmission involves the transfer of an infectious agent through a contaminated inanimate object or person.
The following are examples of opportunities for indirect contact transmission:
• Clothing, uniforms, laboratory coats, or isolation gowns used as PPE may become contaminated with potential pathogens after care of a resident colonized or infected with an infectious agent, (e.g., MRSA, VRE, and C. difficile); and
• Contamination of high touch environmental surfaces (e.g., bedside table, bed rails, toilets, sinks, and handrails), contributes to transmission of pathogens including C. difficile and norovirus.
Certain pathogens may contaminate and survive on equipment and environmental surfaces for long periods of time. Examples include, but are not limited to:
• C. difficile spores can live on inanimate surfaces for up to 5 months;32
• The hepatitis B virus can last up to a week on inanimate surfaces;33 and
• The influenza virus can survive on fomites (e.g., any inanimate object or substance capable of carrying infectious organisms and transferring them from one individual to another) for up to 8 hours.34
Mechanisms to prevent and control transmission of infectious organisms through direct and indirect contact include standard and transmission-based precautions and are described in their subsequent sections.
Standard Precautions
Standard precautions represent the infection prevention measures that apply to all resident care, regardless of suspected or confirmed infection status of the resident, in any setting where healthcare is being delivered. These evidence-based practices are designed to protect healthcare staff and residents by preventing the spread of infections among residents, staff, and visitors, and ensuring staff do not carry infectious pathogens on their hands or via equipment during resident care. As mentioned above in the definitions section, standard precautions include hand hygiene, selection and use of PPE (e.g., gloves, gowns, facemasks, respirators, eye protection), respiratory hygiene and cough etiquette, safe injection practices, environmental cleaning and disinfection, and reprocessing of reusable resident medical equipment. 35, 36
In order to perform hand hygiene appropriately, soap, water, ABHR, and a sink should be readily accessible in appropriate locations including, but not limited to, resident care areas and food and medication preparation areas. Staff involved in direct resident contact must perform hand hygiene (even if gloves are used). Hand hygiene is performed37:
• Before and after contact with the resident;
• Before performing an aseptic task;
• After contact with blood, body fluids, visibly contaminated surfaces or after contact with objects in the resident’s room;
• After removing personal protective equipment (e.g., gloves, gown, facemask);
• After using the restroom; and
• Before meals.
If residents need assistance with hand hygiene, staff should assist with washing hands after toileting, before meals, and use of ABHR or soap and water at other times when indicated.
Certain PPE may be required when working in the facility, such as use of facemasks or eye protection during a respiratory virus pandemic. Additionally, the use of PPE during resident care is determined by the nature of staff interaction and the extent of anticipated blood, body fluid, or pathogen exposure to include contamination of environmental surfaces. Furthermore, appropriate use of PPE includes, but is not limited to, the following:
• Gloves worn before and removed after contact with blood or body fluid, mucous membranes, or non-intact skin;
• Gloves changed and hand hygiene performed before moving from a contaminated-body site to a clean-body site during resident care;
• Gown worn for direct resident contact if the resident has uncontained secretions or excretions or with contaminated or potentially contaminated items;
• Appropriate mouth, nose, and eye protection (e.g., facemasks, face shield) is worn for resident care or procedures that are likely to contaminate mucous membranes, or generate splashes or sprays of blood, body fluids, secretions or excretions;
• PPE appropriately discarded after resident care prior to leaving room followed by hand hygiene; and
• Supplies necessary for adherence to proper PPE use (e.g., gloves, gowns, masks) are readily accessible in resident care areas (i.e., nursing units, therapy rooms) although, equipment supply carts should not be brought into the resident’s room.
The facility must prevent infections through indirect contact transmission. This requires the decontamination (i.e., cleaning and/or disinfecting an object to render it safe for handling) of resident equipment, medical devices, and the environment. Alternatively, the facility may also consider using single-use disposable devices or designating reusable equipment for only an individual resident. NOTE: Additional information related to environmental cleaning may be found in CDC and the Healthcare Infection Control Practices Advisory Committee’s (HICPAC) “Guidelines for Environmental Infection Control in Health-Care Facilities (2003)”at https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html.
Equipment or items in the resident environment likely to have been contaminated with infectious fluids or other potentially infectious matter must be handled in a manner so as to prevent transmission of infectious agents (e.g., wear gloves for handling soiled equipment and properly clean and disinfect or sterilize reusable equipment before use on another resident).38
The CDC has adopted the Spaulding classification system that identifies three risk levels associated with medical and surgical instruments: critical, semi-critical, and noncritical items.
• Critical items (e.g., needles, intravenous catheters, indwelling urinary catheters) enter sterile tissue or the vascular system. These items or equipment must be sterile when used, based on one of several accepted sterilization procedures. Sterilization destroys all viable microorganisms to prevent disease transmission associated with the use of that item. Most of the items in this category should be purchased as sterile or be sterilized;
• Semi-critical items (e.g., dental, podiatry equipment, electric razors) contact mucous membranes or non-intact skin. Such items require meticulous cleaning followed by high-level disinfection treatment using an FDA-approved high-level chemical disinfectant, or they may be sterilized. High-level disinfection is
traditionally defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores. Refer to the specific disinfectant label claim to determine effectiveness; and
• Non-critical items are those that come in contact with intact skin but not mucous membranes. Noncritical items are divided into noncritical resident care items (e.g., blood pressure cuffs, stethoscopes, wheelchairs, therapy equipment) and noncritical environmental surfaces (e.g., bed rails, bedside tables). Non-critical items require cleaning followed by either low- or intermediate-level disinfection following manufacturers’ instructions. Disinfection should be performed with an EPA-registered disinfectant labeled for use in healthcare settings. All applicable label instructions on EPA-registered disinfectant products must be followed (e.g., use-dilution, shelf life, storage, material compatibility, safe use and disposal). 39
• Low-level disinfection is traditionally defined as the destruction of all vegetative bacteria (except tubercle bacilli) and most viruses, some fungi, but not bacterial spores. Examples of low-level disinfectants include EPA-registered hospital disinfectants with an HBV and HIV label claim. Low-level disinfection is generally appropriate for most non-critical equipment.
• Intermediate-level disinfection is traditionally defined as destruction of all vegetative bacteria, including tubercle bacilli, lipid and some nonlipid viruses, and fungi, but not bacterial spores. EPA-registered hospital disinfectants with a tuberculocidal claim are intermediate-level disinfectants. Given the broader spectrum of activity, intermediate-level disinfection should be considered for non-critical equipment that is visibly contaminated with blood. However, a low-level disinfectant with a label claim against HBV and HIV could also be used.40,41
Single-use disposable equipment is an alternative to reprocessing reusable medical instruments. Single-use devices must be discarded after use and are never used for more than one resident. Nursing homes may purchase reprocessed single-use devices when these devices are reprocessed by an entity or a third party reprocessor that is registered with the FDA. The nursing home must have documentation from the third party reprocessor that indicates that it has been cleared by the FDA to reprocess the specific device in question.
NOTE: Additional information related to disinfection and sterilization may be found in CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)” at
https://www.cdc.gov/infectioncontrol/guidelines/Disinfection/index.html.
Enhanced Barrier Precautions (EBP)
EBP are used in conjunction with standard precautions and expands the use of PPE to donning of gown and gloves during high-contact resident care activities that provide opportunities for transfer of MDROs to staff hands and clothing.
EBP are indicated for residents with any of the following:
• Infection or colonization with a CDC-targeted MDRO when Contact Precautions do not otherwise apply; or
• Wounds and/or indwelling medical devices even if the resident is not known to be infected or colonized with a MDRO.
Wounds generally include chronic wounds, not shorter-lasting wounds, such as skin breaks or skin tears covered with an adhesive bandage (e.g., Band-Aid®) or similar dressing. Examples of chronic wounds include, but are not limited to, pressure ulcers, diabetic foot ulcers, unhealed surgical wounds, and venous stasis ulcers.
Indwelling medical device examples include central lines, urinary catheters, feeding tubes, and tracheostomies. A peripheral intravenous line (not a peripherally inserted central catheter) is not considered an indwelling medical device for the purpose of EBP.
EBP should be used for any residents who meet the above criteria, wherever they reside in the facility.
Facilities have discretion in using EBP for residents who do not have a chronic wound or indwelling medical device and are infected or colonized with an MDRO that is not currently targeted by CDC.
Implementing Contact versus Enhanced Barrier Precautions
This table only applies to MDROs not all pathogens that may require use of transmission-based precautions.
| Resident Status | Contact Precautions | Use EBP |
| Infected or colonized with any MDRO & has secretions or excretions that are unable to be covered or contained | Yes | No |
| Infected or colonized with a CDC-targeted MDRO without a wound, indwelling medical device or secretions or excretions that are unable to be covered or contained | No | Yes |
|
Infected or colonized with a non-CDC targeted MDRO without a wound, indwelling medical device, or secretions or excretions that are unable to be covered or contained. |
No | At the discretion of the facility |
| Has a wound or indwelling medical device, and secretions or excretions that are unable to be covered or contained and are not known to be infected or colonized with any MDRO. | Yes, unless/until a specific organism is identified |
Yes, if they do not meet the criteria for contact precautions. |
|
Has a wound or indwelling medical device, without secretions or excretions that are unable to be covered or contained and are not known to be infected or colonized with any MDRO. |
No | Yes |
Examples of secretions or excretions include wound drainage, fecal incontinence or diarrhea, or other discharges from the body that cannot be contained and pose an increased potential for extensive environmental contamination and risk of transmission of a pathogen.
For residents whom EBP are indicated, EBP is employed when performing the following high-contact resident care activities:
• Dressing
• Bathing/showering
• Transferring
• Providing hygiene
• Changing linens
• Changing briefs or assisting with toileting
• Device care or use: central line, urinary catheter, feeding tube, tracheostomy/ventilator
• Wound care: any skin opening requiring a dressing
Note: In general, gowns and gloves would not be recommended when performing transfers in common areas such as dining or activity rooms, where contact is anticipated to be shorter in duration. Outside the resident’s room, EBP should be followed when performing transfers or assisting during bathing in a shared/common shower room and when working with residents in the therapy gym, specifically when anticipating close physical contact while assisting with transfers and mobility.
Residents are not restricted to their rooms or limited from participation in group activities. Because EBP do not impose the same activity and room placement restrictions as Contact Precautions, they are intended to be in place for the duration of a resident’s stay in the facility or until resolution of the wound or discontinuation of the indwelling medical device that placed them at higher risk.
Facilities have discretion on how to communicate to staff which residents require the use of EBP. CMS supports facilities in using creative (e.g., subtle) ways to alert staff when EBP use is necessary to help maintain a home-like environment, as long as staff are aware of which residents require the use of EBP prior to providing high-contact care activities.
Facilities should ensure PPE and alcohol-based hand rub are readily accessible to staff. Discretion may be used in the placement of supplies which may include placement near or outside the resident’s room. PPE for enhanced barrier precautions is only necessary when performing high-contact care activities and may not need to be donned prior to entering the resident’s room. For example, staff entering the resident’s room to answer a call light, converse with a resident or provide medications and who do not engage in a high-contact resident care activity would likely not need to employ EBP while interacting with the resident.
Information regarding CDC-targeted MDROs and current recommendations on Enhanced Barrier Precautions are available on the CDC’s Implementation of Personal Protective Equipment (PPE) Use in Nursing Homes to Prevent Spread of Multidrugresistant Organisms (MDROs) webpage at https://www.cdc.gov/hai/containment/PPENursing-Homes.html.
Surveyors will evaluate the use of EBP when reviewing sampled residents for whom EBP are indicated and focus their evaluation of EBP use as it relates to CDC-targeted MDROs.
Transmission-based Precautions
There are three categories of transmission-based precautions: contact precautions, droplet precautions, and airborne precautions. Transmission-based precautions are used when the route(s) of transmission is (are) not completely interrupted using standard precautions alone. For some diseases that have multiple routes of transmission, more than one
transmission-based precautions category may be required. Whether used singly or in combination, they must always be used in addition to standard precautions. The type of PPE and precautions used depends on the potential for exposure, route of transmission, and infectious organism/pathogen (or clinical syndrome if an organism is not yet identified).
The diagnosis of many infections is based on clinical signs and symptoms, but often requires laboratory confirmation. However, since laboratory tests (especially those that depend on culture techniques) may require two or more days to complete, transmission-based precautions may need to be implemented while test results are pending, based on the clinical presentation and the likely category of pathogens.42,43
The facility should initiate transmission-based precautions for a constellation of new symptoms consistent with a communicable disease. Empirically initiated transmission-based precautions may be adjusted or discontinued when additional clinical information becomes available (e.g., confirmatory laboratory results).
Facility policies must identify the type (i.e., contact, droplet, airborne) and duration of the transmission-based precautions required, depending upon the infectious pathogen involved. Residents on transmission-based precautions should remain in their rooms except for medically necessary care.44 Furthermore, transmission-based precautions should be the least restrictive possible for the resident based on his/her clinical situation and used for the least amount of time. When used appropriately, transmission-based precautions are not to be considered involuntary seclusion. However, once the resident is no longer a risk for transmitting the pathogen (e.g., duration of the illness and/or can contain secretions), removing transmission-based precautions is required in order to avoid unnecessary involuntary seclusion.
Facility staff should take measures to reduce or minimize any potential psychosocial negative effects of isolation for whom transmission-based precautions are being used. Boredom, anger, withdrawal or depression are just some of the mood changes that could occur. The facility must pro-actively ensure that individualized needs (e.g., activities) are met.
Implementation of Transmission-Based Precautions
When implementing transmission-based precautions, consideration should be given to the following:
• The identification of resident risk factors that increase the likelihood of transmission (such as uncontained secretions or excretions, non-compliance, cognition deficits, incontinence, etc.);
• The provision of a private room as available/appropriate;
• Cohorting residents with the same pathogen; and
• Sharing a room with a roommate with limited risk factors (e.g., without indwelling or invasive devices, without open wounds, and not immunocompromised) as appropriate based on the pathogen and method of transmission.45
When a resident is placed on transmission-based precautions, facility staff should implement the following:
• Clearly identify the type of precautions and the appropriate PPE to be used;
• Place signage that includes instructions for use of specific PPE in a conspicuous location outside the resident’s room (e.g., on the door or on the wall next to the doorway), wing, or facility-wide. Additionally, either the CDC category of transmission-based precautions (e.g., contact, droplet, or airborne) or instructions to see the nurse before entering should be included in signage. Ensure that signage also complies with residents’ rights to confidentiality and privacy;
• Make PPE readily available near the entrance to the resident’s room;
• Don appropriate PPE before or upon entry into the environment (e.g., room or cubicle) of a resident on transmission-based precautions (e.g., contact precautions);
• Use disposable or dedicated noncritical resident-care equipment (e.g., blood pressure cuff, bedside commode). If noncritical equipment is shared between residents, it will be cleaned and disinfected following manufacturer’s instructions with an EPA-registered disinfectant after use; 46
• Clean and disinfect objects and environmental surfaces that are touched frequently (e.g., bed rails, over-bed table, bedside commode, lavatory surfaces in resident bathrooms) with an EPA-registered disinfectant for healthcare use at least daily and when visibly soiled; 47 and
• Provide education to residents (to the degree possible/consistent with the resident’s capacity) and their representatives or visitors on the use of transmission-based precautions.
Resources are available for current recommendations on standard and transmission-based precautions, such as:
• “Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007)” https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html; and
• “Management of Multidrug-resistant Organisms In Healthcare Settings (2006)” https://www.cdc.gov/infectioncontrol/guidelines/mdro/index.html.
Contact Precautions
Contact precautions are intended to prevent transmission of pathogens that are spread by direct (e.g., person-to-person) or indirect contact with the resident or environment (e.g., C. difficile, norovirus, scabies), and requires the use of appropriate PPE, including a gown and gloves before or upon entering (i.e., before making contact with the resident or resident’s environment) the room or cubicle. Prior to leaving the resident’s room or cubicle, the PPE is removed and hand hygiene is performed.
Contact precautions should also be used in situations when a resident is experiencing wound drainage, fecal incontinence or diarrhea, or other discharges from the body that cannot be contained and suggest an increased potential for extensive environmental contamination and risk of transmission of a pathogen, even before a specific organism has been identified.
MDRO Colonization and Infection
Contact precautions are used for residents infected or colonized with MDROs in the following situations:
• Presence of acute diarrhea, draining wounds or other sites of secretions or excretions that are unable to be covered or contained;
• Co-infection with another organism for which Contact Precautions is recommended (e.g., norovirus);
• For a limited time period, as determined in consultation with public health authorities, on units or in facilities during the investigation of a suspected or confirmed MDRO outbreak
-
When otherwise directed by public health authorities.
PPE should be used for residents who do not meet criteria above for contact precautions but are infected or colonized with MDROs (or have risk factors for MDRO acquisition). See the section on EBP in this guidance.
NOTE: Additional information related to MDROs may be found in CDC’s “Implementation of Personal Protective Equipment in Nursing Homes to Prevent Spread of Novel or Targeted Multidrug-resistant Organisms (MDROs)” at https://www.cdc.gov/hai/containment/PPE-Nursing-Homes.html.
Droplet Precautions
The use of droplet precautions applies when respiratory droplets contain pathogens which may be spread to another susceptible individual. Respiratory pathogens can enter the body via the nasal mucosa, conjunctivae and less frequently the mouth.48 Examples of droplet-borne organisms that may cause infections include, but are not limited to Mycoplasma pneumoniae, influenza, and other respiratory viruses.
Respiratory droplets are generated when an infected person coughs, sneezes, talks, or during procedures such as suctioning, endotracheal intubation, cough induction by chest physiotherapy, and cardiopulmonary resuscitation.49 The maximum distance for droplet transmission is currently unresolved, but the area of defined risk based on epidemiological findings is approximately 3-10 feet.50 In contrast to airborne pathogens, droplet-borne pathogens are generally not transmitted through the air over long distances.
Facemasks should be used upon entry into a resident’s room or cubicle with respiratory droplet precautions.51 Based upon the pathogen or clinical syndrome, if there is risk of exposure of mucous membranes or substantial spraying of respiratory secretions is anticipated, gloves and gown as well as goggles (or face shield in place of goggles) should be worn.52 The preference for a resident on droplet precautions would be to place the resident in a private room.53 If a private room is not available, the resident could be cohorted with a resident with the same infectious agent. If it becomes necessary for a resident who requires droplet precautions to share a room with a resident who does not have the same infection, the facility should make decisions regarding resident placement on a case-by-case basis after considering infection risks to other residents in the room and available alternatives.54 Spatial separation and drawing the curtain between resident beds is especially important for residents in multi-bed rooms with infections transmitted by the droplet route.55 A resident who is on droplet precautions for the duration of the illness (e.g., influenza), should wear a facemask (e.g., surgical or procedure facemask) when leaving his/her room.
Airborne Precautions
Airborne transmission occurs when pathogens are so small that they can be easily dispersed in the air, and because of this, there is a risk of transmitting the disease through inhalation. These small particles containing infectious agents may be dispersed over long distances by air currents and may be inhaled by individuals who have not had face-to-face contact with (or been in the same room with) the infectious individual. Staff caring for residents on airborne precautions should wear a fit-tested N95 or higher level respirator that is donned prior to room entry.56
NOTE: According to the CDC, preventing the spread of pathogens that are transmitted by the airborne route requires the use of special air handling and ventilation systems such as an airborne infection isolation room (AIIR) to contain and then safely remove the infectious agent.57
Residents with infections requiring an AIIR must be transported to an acute care setting unless the facility can place the resident in a private AIIR room with the door closed. In cases when AIIR is required, such as for a resident with TB, it is important for the facility to have a plan (e.g., public health notification and exposure workup) in place to effectively manage a situation involving a resident with suspected or active TB while awaiting the resident’s transfer to an acute care setting.58
Medical Device Safety
Medical devices may be used for administration of medications, point-of-care testing, or for other medical uses.
Point-of-Care Testing
Point-of-care testing is diagnostic testing that is performed at or near the site of resident care. This may be accomplished through use of portable, handheld instruments such as blood glucose meters or prothrombin time meters. This testing may involve obtaining a blood specimen from the resident using a fingerstick device. The guidance regarding fingerstick devices and blood glucose meters is applicable to other point-of-care devices where a blood specimen is obtained (e.g., prothrombin time meters).
Fingerstick Devices
CDC recommends the use of single-use, auto-disabling fingerstick devices in settings where assisted blood glucose monitoring is performed. This practice prevents inadvertent reuse of fingerstick devices for more than one person. Additionally, the use of single-use, auto-disabling fingerstick devices protects healthcare staff from needlestick injuries. If reusable fingerstick devices are used for assisted monitoring of blood glucose, then they must never be used for more than one resident. Although the package instructions for some fingerstick devices may indicate or imply the potential for multiple resident use, CMS guidance, based upon nationally recognized standards of practice from the CDC and FDA, prohibits the use of fingerstick devices for more than one resident.
NOTE: If fingerstick devices are used on more than one resident, surveyors must cite at this tag and utilize the guidelines in Appendix Q for immediate jeopardy. Furthermore, the SA must notify the appropriate local/state public health authority of the deficient practice.
Resources are available on fingerstick safety, such as:
