Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care

Adhere to Standard Precautions

Standard Precautions are the minimum infection prevention practices that apply to all patient care, regardless of suspected or confirmed infection status of the patient, in any setting where healthcare is delivered. These practices are designed to both protect HCP and prevent HCP from spreading infections among patients. Standard Precautions include: 1) hand hygiene, 2) use of personal protective equipment (e.g., gloves, gowns, masks), 3) safe injection practices, 4) safe handling of potentially contaminated equipment or surfaces in the patient environment, and 5) respiratory hygiene/cough etiquette. Each of these elements of Standard Precautions are described in the sections that follow.

Education and training on the principles and rationale for recommended practices are critical elements of Standard Precautions because they facilitate appropriate decision-making and promote adherence. Further, at the facility level, an understanding of the specific procedures performed and typical patient interactions, as described above in Administrative Measures as part of policy and procedure development, will assure that necessary equipment is available.

The application of Standard Precautions and guidance on appropriate selection and an example of donning and removal of personal protective equipment is described in detail in the 2007 Guideline for Isolation Precautions [PDF - 3.80 MB].

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Hand Hygiene

Good hand hygiene, including use of alcohol-based hand rubs and handwashing with soap and water, is critical to reduce the risk of spreading infections in ambulatory care settings. Use of alcohol-based hand rub as the primary mode of hand hygiene in healthcare settings is recommended by the CDC and the World Health Organization (WHO) because of its activity against a broad spectrum of epidemiologically important pathogens, and because compared with soap and water, use of ABHR in healthcare settings can increase compliance with recommended hand hygiene practices by requiring less time, irritating hands less, and facilitating hand hygiene at the patient bedside. For these reasons, alcohol-based hand rub is the preferred method for hand hygiene except when hands are visibly soiled (e.g., dirt, blood, body fluids), or after caring for patients with known or suspected infectious diarrhea (e.g., Clostridium difficile, norovirus), in which case soap and water should be used.

Complete guidance on how and when hand hygiene should be performed, including recommendations regarding surgical hand antisepsis and artificial nails can be found in the Guideline for Hand Hygiene in Health-Care Settings [PDF - 495 KB].

Key recommendations for hand hygiene in ambulatory care settings:

1. Key situations where hand hygiene should be performed include:
   1. Before touching a patient, even if gloves will be worn
   2. Before exiting the patient’s care area after touching the patient or the patient’s immediate environment
   3. After contact with blood, body fluids or excretions, or wound dressings
   4. Prior to performing an aseptic task (e.g., placing an IV, preparing an injection)
   5. If hands will be moving from a contaminated-body site to a clean-body site during patient care
   6. After glove removal
2. Use soap and water when hands are visibly soiled (e.g., blood, body fluids), or after caring for patients with known or suspected infectious diarrhea (e.g., Clostridium difficile, norovirus). Otherwise, the preferred method of hand decontamination is with an alcohol-based hand rub.

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Personal Protective Equipment

Personal Protective Equipment (PPE) refers to wearable equipment that is intended to protect HCP from exposure to or contact with infectious agents. Examples include gloves, gowns, face masks, respirators, goggles and face shields. The selection of PPE is based on the nature of the patient interaction and potential for exposure to blood, body fluids or infectious agents. Examples of appropriate use of PPE for adherence to Standard Precautions include: use of gloves in situations involving possible contact with blood or body fluids, mucous membranes, non-intact skin or potentially infectious material; use of a gown to protect skin and clothing during procedures or activities where contact with blood or body fluids is anticipated; use of mouth, nose and eye protection during procedures that are likely to generate splashes or sprays of blood or other body fluids. Hand hygiene is always the final step after removing and disposing of PPE.

In addition to protection of HCP, face masks are also effective in limiting the dispersal of oropharyngeal droplets and are recommended when placing a catheter or injecting materials into epidural or subdural spaces, as during myelography or spinal or epidural anesthesia. Failure to wear face masks during these procedures has resulted in development of bacterial meningitis in patients undergoing these procedures[10]. Each ambulatory care facility/setting should evaluate the services they provide to determine specific needs and to assure that sufficient and appropriate PPE is available for adherence to Standard Precautions. All HCP at the facility should be educated regarding proper selection and use of PPE.

Complete guidance on the appropriate selection of PPE, including one approach for donning and removing PPE is provided in the 2007 Guideline for Isolation Precautions [PDF - 3.80 MB].

Key recommendations for use of PPE in ambulatory care settings:

1. Facilities should assure that sufficient and appropriate PPE is available and readily accessible to HCP
2. Educate all HCP on proper selection and use of PPE
3. Remove and discard PPE before leaving the patient’s room or area
4. Wear gloves for potential contact with blood, body fluids, mucous membranes, non-intact skin or contaminated equipment
   1. Do not wear the same pair of gloves for the care of more than one patient
   2. Do not wash gloves for the purpose of reuse
   3. Perform hand hygiene immediately after removing gloves
5. Wear a gown to protect skin and clothing during procedures or activities where contact with blood or body fluids is anticipated
   1. Do not wear the same gown for the care of more than one patient
6. Wear mouth, nose and eye protection during procedures that are likely to generate splashes or sprays of blood or other body fluids
7. Wear a surgical mask when placing a catheter or injecting material into the spinal canal or subdural space

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Injection Safety

Injection safety includes practices intended to prevent transmission of infectious diseases between one patient and another, or between a patient and healthcare provider during preparation and administration of parenteral medications.

Implementation of the OSHA Bloodborne Pathogens Standard has helped increase the protection of HCP from blood exposure and sharps injuries, but there is room for improvement in ambulatory care settings. For example, efforts to increase uptake of hepatitis B vaccination and implementation of safety devices that are designed to decrease risks of sharps injury are needed.

Further attention to patient protection is also needed as evidenced by continued outbreaks in ambulatory settings resulting from unsafe injection practices. Unsafe practices that have led to patient harm include 1) use of a single syringe, with or without the same needle, to administer medication to multiple patients, 2) reinsertion of a used syringe, with or without the same needle, into a medication vial or solution container (e.g., saline bag) to obtain additional medication for a single patient and then using that vial or solution container for subsequent patients, 3) preparation of medications in close proximity to contaminated supplies or equipment.

Complete guidance on safe injection practices can be found in the 2007 Guideline for Isolation Precautions [PDF - 3.80 MB]. Additional materials including a list of frequently asked questions from providers as well as an injection safety training video are also available.

Key recommendations for safe injection practices in ambulatory care settings:

1. Use aseptic technique when preparing and administering medications
2. Cleanse the access diaphragms of medication vials with 70% alcohol before inserting a device into the vial
3. Never administer medications from the same syringe to multiple patients, even if the needle is changed or the injection is administered through an intervening length of intravenous tubing
4. Do not reuse a syringe to enter a medication vial or solution
5. Do not administer medications from single-dose or single-use vials, ampoules, or bags or bottles of intravenous solution to more than one patient
6. Do not use fluid infusion or administration sets (e.g., intravenous tubing) for more than one patient
7. Dedicate multidose vials to a single patient whenever possible. If multidose vials will be used for more than one patient, they should be restricted to a centralized medication area and should not enter the immediate patient treatment area (e.g., operating room, patient room/cubicle)
8. Dispose of used syringes and needles at the point of use in a sharps container that is closable, puncture-resistant, and leak-proof.
9. Adhere to federal and state requirements for protection of HCP from exposure to bloodborne pathogens.

Environmental Cleaning

Ambulatory care facilities should establish policies and procedures for routine cleaning and disinfection of environmental surfaces as part of their infection prevention plan. Cleaning refers to the removal of visible soil and organic contamination from a device or environmental surface using the physical action of scrubbing with a surfactant or detergent and water, or an energy-based process (e.g., ultrasonic cleaners) with appropriate chemical agents. This process removes large numbers of microorganisms from surfaces and must always precede disinfection. Disinfection is generally a less lethal process of microbial inactivation (compared to sterilization) that eliminates virtually all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores).

Emphasis for cleaning and disinfection should be placed on surfaces that are most likely to become contaminated with pathogens, including those in close proximity to the patient (e.g., bedrails) and frequently-touched surfaces in the patient-care environment (e.g., doorknobs). Facility policies and procedures should also address prompt and appropriate cleaning and decontamination of spills of blood or other potentially infectious materials.

Responsibility for routine cleaning and disinfection of environmental surfaces should be assigned to appropriately trained HCP. Cleaning procedures can be periodically monitored or assessed to ensure that they are consistently and correctly performed. EPA-registered disinfectants or detergents/disinfectants with label claims for use in healthcare should be selected for disinfection. Disinfectant products should not be used as cleaners unless the label indicates the product is suitable for such use. Healthcare professionals should follow manufacturer’s recommendations for use of products selected for cleaning and disinfection (e.g., amount, dilution, contact time, safe use, and disposal).

Complete guidance for the cleaning and disinfection of environmental surfaces, including for cleaning blood or body substance spills, is available in the Guidelines for Environmental Infection Control in Health-Care Facilities [PDF - 1.4 MB] and the Guideline for Disinfection and Sterilization in Healthcare Facilities [PDF - 948 KB]

Key recommendations for cleaning and disinfection of environmental surfaces in ambulatory care settings:

1. Establish policies and procedures for routine cleaning and disinfection of environmental surfaces in ambulatory care settings
   1. Focus on those surfaces in proximity to the patient and those that are frequently touched
2. Select EPA-registered disinfectants or detergents/disinfectants with label claims for use in healthcare
3. Follow manufacturer’s recommendations for use of cleaners and EPA-registered disinfectants (e.g., amount, dilution, contact time, safe use, and disposal)

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Medical Equipment

Medical equipment is labeled by the manufacturer as either reusable or single-use. Reusable medical equipment (e.g., endoscopes) should be accompanied by instructions for cleaning and disinfection or sterilization as appropriate. Single-use devices (SUDs) are labeled by the manufacturer for only a single use and do not have reprocessing instructions. They may not be reprocessed except by entities which have complied with FDA regulatory requirements and have received FDA clearance to reprocess specific SUDs as outlined in FDA Guidance for Industry and FDA Staff. Legally marketed SUDs are available from FDA-registered Third Party Reprocessors.

All reusable medical equipment must be cleaned and maintained according to the manufacturer’s instructions to prevent patient-to-patient transmission of infectious agents. The Spaulding Classification is a traditional approach that has been used to determine the level of disinfection or sterilization required for reusable medical devices, based upon the degree of risk for transmitting infections if the device is contaminated at the time of use.

• Critical items (e.g., surgical instruments) are objects that enter sterile tissue or the vascular system and must be sterile prior to use.
• Semi-critical items (e.g., endoscopes used for upper endoscopy and colonoscopy) contact mucous membranes or non-intact skin and require, at a minimum, high-level disinfection prior to reuse.
• Noncritical items (e.g., blood pressure cuffs) are those that may come in contact with intact skin but not mucous membranes and should undergo low- or intermediate-level disinfection depending on the nature and degree of contamination.
• Environmental surfaces (e.g., floors, walls) are those that generally do not contact the patient during delivery of care. Cleaning may be all that is needed for the management of these surfaces but if disinfection is indicated, low-level disinfection is appropriate.

Cleaning to remove organic material must always precede disinfection or sterilization because residual debris reduces the effectiveness of the disinfection and sterilization processes.

Facilities should establish policies and procedures for containing, transporting, and handling equipment that may be contaminated with blood or body fluids. Manufacturer’s instructions for reprocessing any reusable medical equipment in the facility (including point-of-care devices such as blood glucose meters) should be readily available and used to establish clear and appropriate policies and procedures. Instructions should be posted at the site where equipment reprocessing is performed. Responsibility for cleaning, disinfection and/or sterilization of medical equipment should be assigned to HCP with training in the required reprocessing steps and in the appropriate use of PPE necessary for handling of contaminated equipment. Competencies of HCP responsible for reprocessing of equipment should be documented initially upon assignment of those duties, whenever new equipment is introduced, and periodically (e.g., semi-annually).

Recommendations for the cleaning, disinfection, and sterilization of medical equipment, including general guidance on endoscope reprocessing are available in the Guideline for Disinfection and Sterilization in Healthcare Facilities [PDF - 948 KB]. Materials specific for the handling of blood glucose monitoring equipment are also available.

FDA regulations on reprocessing of single-use devices are available.

Key recommendations for cleaning, disinfection, and/or sterilization of medical equipment in ambulatory care settings:

1. Facilities should ensure that reusable medical equipment (e.g., blood glucose meters and other point-of-care devices, surgical instruments, endoscopes) is cleaned and reprocessed appropriately prior to use on another patient
2. Reusable medical equipment must be cleaned and reprocessed (disinfection or sterilization) and maintained according to the manufacturer’s instructions. If the manufacturer does not provide such instructions, the device may not be suitable for multi-patient use
3. Assign responsibilities for reprocessing of medical equipment to HCP with appropriate training
   1. Maintain copies of the manufacturer’s instructions for reprocessing of equipment in use at the facility; post instructions at locations where reprocessing is performed
   2. Observe procedures to document competencies of HCP responsible for equipment reprocessing upon assignment of those duties, whenever new equipment is introduced, and on an ongoing periodic basis (e.g., quarterly)
4. Assure HCP have access to and wear appropriate PPE when handling and reprocessing contaminated patient equipment

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Respiratory Hygiene/Cough Etiquette

Respiratory Hygiene/Cough Etiquette is an element of Standard Precautions that highlights the need for prompt implementation of infection prevention measures at the first point of encounter with the facility/ambulatory settings (e.g., reception and triage areas). This strategy is targeted primarily at patients and accompanying family members or friends with undiagnosed transmissible respiratory infections, and applies to any person with signs of illness including cough, congestion, rhinorrhea, or increased production of respiratory secretions when entering the facility.

Additional information related to respiratory hygiene/cough etiquette can be found in the 2007 Guideline for Isolation Precautions [PDF - 3.80 MB]. Recommendations for preventing the spread of influenza are also available.

Key recommendations for Respiratory Hygiene/Cough Etiquette in ambulatory care settings:

1. Implement measures to contain respiratory secretions in patients and accompanying individuals who have signs and symptoms of a respiratory infection, beginning at point of entry to the facility and continuing throughout the duration of the visit.
   1. Post signs at entrances with instructions to patients with symptoms of respiratory infection to:
      1. Cover their mouths/noses when coughing or sneezing
      2. Use and dispose of tissues
      3. Perform hand hygiene after hands have been in contact with respiratory
      secretions
   2. Provide tissues and no-touch receptacles for disposal of tissues
   3. Provide resources for performing hand hygiene in or near waiting areas
   4. Offer masks to coughing patients and other symptomatic persons upon entry to the facility
   5. Provide space and encourage persons with symptoms of respiratory infections to sit as far away from others as possible. If available, facilities may wish to place these patients in a separate area while waiting for care
2. Educate HCP on the importance of infection prevention measures to contain respiratory secretions to prevent the spread of respiratory pathogens when examining and caring for patients with signs and symptoms of a respiratory infection.

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Additional Considerations

The majority of ambulatory care settings are not designed to implement all of the isolation practices and other Transmission-Based Precautions (e.g., Airborne Precautions for patients with suspected tuberculosis, measles or chicken pox) that are recommended for hospital settings. Nonetheless, specific syndromes involving diagnostic uncertainty (e.g., diarrhea, febrile respiratory illness, febrile rash) are routinely encountered in ambulatory settings and deserve appropriate triage. Facilities should develop and implement systems for early detection and management of potentially infectious patients at initial points of entry to the facility. To the extent possible, this includes prompt placement of such patients into a single-patient room and a systematic approach to transfer when appropriate. When arranging for patient transfer, facilities should inform the transporting agency and the accepting facility of the suspected infection type.

Additional information related to Transmission-Based Precautions (contact precautions, droplet precautions and airborne precautions) can be found in the 2007 Guideline for Isolation Precautions [PDF - 3.80 MB]. Recommendations regarding management of multidrug-resistant organisms can be found in the Guideline for the Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006 [PDF - 233 KB].

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Conclusions

The recommendations described in the preceding document represent the absolute minimum infection prevention expectations for safe care in outpatient (ambulatory care) settings. This guidance is not all-encompassing. Facilities and HCP are encouraged to refer to the original source documents, which provide more detailed guidance and references for the information included in this document.