§484.70 Condition of participation: Infection prevention and control.

Interpretive Guidelines § 484.70

The home health setting presents unique challenges for infection control, because: care is delivered in the home environment, not a structured facility; sterile supplies are transported by staff and may need to be stored and protected in the home; and patients may not have access to basic hygiene necessities in their home. It is essential that HHAs have a comprehensive and effective infection control program, because the consequences of poor infection prevention and control can be very serious.

The manner and degree of noncompliance identified in relation to the standard level tags for §484.70 may result in substantial noncompliance with this CoP, requiring citation at the condition level.

Survey Procedures § 484.70

• Surveyors will focus their observation of infection control practices by the HHA during home visits. • Determine whether the policies and procedures of the HHA’s infection control program are implemented correctly based on observations of care. • Determine that there is an ongoing, documented program for the prevention and control of infections and communicable diseases among patients and HHA personnel.

Interpretive Guidelines §484.70(a)

Federal and state agencies such as the Centers for Disease Control and Prevention (CDC) and state departments of health, national professional organizations, have all developed infection prevention and control standards of practice. Examples of national organizations that promulgate nationally recognized infection and communicable disease control guidelines, and/or recommendations include: the CDC, the Association for Professionals in Infection Control and Epidemiology (APIC), and the Society for Healthcare Epidemiology of America (SHEA). An HHA should identify the source of the standards it selects and be capable of explaining why those standards were chosen for incorporation into the HHA’s infection prevention and control program (82 FR 4543).

Standard precautions must be used to prevent transmission of infectious agents. “Standard precautions” are a group of infection practices that apply to all patients regardless of suspected or confirmed infection status at the time health care is delivered. These practices protect healthcare personnel and prevent healthcare personnel or the environment from transmitting infections to patients.

For example, the following are six (6) core practices, identified by the CDC are based on the CDC’s “Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings –Recommendations of The Healthcare Infection Control Practices Advisory Committee (HICPAC), 1 which is periodically updated. These are a core set of infection prevention and control practices that are recommended in all healthcare settings, regardless of the type of healthcare provided. Also, refer to “Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care” published by the National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion, Version 2.3.

1. Hand Hygiene

HHAs and surveyors are advised to review the most current CDC’s hand hygiene recommendations for correct procedures. Hand Hygiene should be performed:

• Before and after contact with a patient; • Before performing an aseptic task (e.g., insertion of IV, preparing an injection, performing wound care); • After contact with blood, body fluids or contaminated surfaces; • After contact with the patient’s immediate environment; • When moving from a contaminated body site to a clean body site during patient care; and • After removal of personal protective equipment (e.g., gloves, gown, facemask).

1 https://www.cdc.gov/hicpac/pdf/core-practices.pdf.

The term “hand hygiene” includes both handwashing with either plain or antiseptic- containing soap and water, and use of alcohol-based products (gels, rinses, foams) that do not require the use of water. In the absence of visible soiling of hands, approved alcohol-based products for hand disinfection are preferred over antimicrobial or plain soap and water because of their superior microbiocidal activity, reduced drying of the skin, and convenience. The HHA must ensure that supplies necessary for adherence to hand hygiene are provided.

2. Environmental cleaning and disinfection

Environmental cleaning and disinfection presents a unique challenge for HHA personnel. The HHA staff have little control over the home environment but must protect their equipment and supplies during the home visit. Examples of how this might be accomplished include but are not limited to: Cleaning and disinfecting or placing a clean barrier on the surface in the home where clean equipment will be placed and/or preparation of injectable medications will be performed. Additionally, items that are taken from one home to another should be cleaned and disinfected in accordance with accepted standards of practice, which include manufacturer’s instructions for use.

3. Injection and Medication Safety

Safe injection practices include but are not limited to:

• Use of aseptic technique when preparing and administering medications; • Not reusing needles, lancets, lancet holding devices, or syringes for more than one use on one patient; using single-dose vials for parenteral medications whenever possible; • Not administering medications from a single-dose vial or ampule to multiple patients; • Use of fluid infusion and administration sets (i.e., intravenous bags, tubing and connectors) for one patient only and disposal appropriately after use; • Considering a syringe or needle/cannula contaminated once it has been used to enter or connect to patient’s intravenous infusion bag or administration set; • Entering medication containers with a new needle and a new syringe even when obtaining additional doses for the same patient; • Insulin pens are dedicated for a single patient and never shared even if the needle is changed; and, • Sharps disposal complies with applicable state and local laws and regulations.

4. Appropriate Use of Personal Protective Equipment

Appropriate Use of Personal Protective Equipment (PPE) is the use of specialized clothing or equipment worn for protection and as a barrier against infectious materials or any potential infectious exposure. PPE protects the caregiver’s skin, hands, face, respiratory tract, and/or clothing from exposure. Examples of PPE include: gloves, gowns, face protection (facemask and goggles or face shields). The selection and use of PPE is determined by the nature of patient interaction and potential for exposure to blood, body fluids and/or infectious materials.

5. Minimizing Potential Exposures

Minimizing Potential Exposures in the home health setting focuses on prevention of reducing the exposure and transmission of respiratory infections. HHA staff should also be careful to minimize potential exposures to infectious agents while transporting medical specimens and medical waste, such as sharps.

6. Reprocessing, Storage, Transport, and Usage/Operation of Equipment or Devices Used for Patient Care

Cleaning and disinfecting of medical equipment is essential. Staff should follow the manufacturer’s instructions for reprocessing (i.e., cleaning and disinfection or cleaning and sterilization) and use and current standards of practice for transport and storage of patient care equipment. Single-use equipment is discarded after use according to the manufacturer’s instructions for proper disposal. Reusable medical equipment (e.g., blood glucose meters and other point-of-care meters, blood pressure cuffs, oximeter probes) are reprocessed prior to use on another patient and when soiled. The HHA must ensure that HHA staff are trained to maintain separation between clean and soiled equipment to prevent cross contamination in the patient care environment and during transport.

Interpretive Guidelines §484.70(b)

The HHA should have a program for the surveillance, identification, prevention, control and investigation of infectious and communicable diseases specific to care and services provided in the home setting. The CDC defines surveillance as “the ongoing, systematic collection, analysis, interpretation and evaluation of health data closely integrated with the timely dissemination of this data to those who need it.”

As part of its infection control program the HHA should: (1) observe and evaluate services from all disciplines to identify sources or causative factors of infection, track patterns and trends of infections; and (2) establish a corrective plan for infection control (if appropriate) and monitor the effectiveness of the corrective plan. Cross Reference to §484.65(a), QAPI Program Scope.

Interpretive Guidelines §484.70(b)(1)

The HHA must develop a procedure for the identification of infections or risk of infections among patients. It is the prerogative of the HHA to determine the methodology to be used for such identification. Example methodologies include, but are not limited to:

• Clinical record review; • Staff reporting procedures; • Review of laboratory results; • Data analysis of physician or allowed practitioner and emergency room visits for symptoms of infection; and • Identification of root cause of infection through evaluation of HHA personnel technique and self-care technique by patients or caregivers.

Analysis of surveillance data should be used to improve care practices and control infections and transmission of communicable diseases.

While not required by the regulation, CMS suggests HHAs have a way to receive alerts from the CDC Health Alert Network or local public health network as a means of staying up to date with alerts and information related to public health incidents (as seen with the 2019 Novel Coronavirus public health emergency).

Interpretive Guidelines §484.70(b)(2)

The HHA must develop an action plan to address or prevent infections or transmission of communicable diseases. Such plan should be based on surveillance findings, any identified root cause of infection or disease transmission, tracking data and analysis of data findings.

Actions to facilitate improvements and disease prevention may include the following: • Policy, procedure or practice changes to improve care; • Education for patients, caregivers, and HHA personnel to prevent infections and transmission of communicable diseases; and • The development of process or outcome measures which could be used to monitor and address identified issues (e.g., infection prevention and control observations for technique).

The HHA must evaluate and revise the plan as needed.

Interpretive Guidelines §484.70(c)

The regulation does not specify the form or content of education regarding infection prevention and control. However, in accordance with requirements under §484.60, patients and caregivers must be provided with education and training specific to the individualized plan of care. HHAs should also take into consideration the patient’s and caregiver(s)’ health conditions and individual learning needs. The HHA should review training information with the patient and his or her representative (if any), including information on how to clean and care for equipment (e.g., blood glucose meters or reusable catheters), at sufficient intervals to reinforce comprehension of the training.

Additionally, HHAs must provide infection control education to staff.

HHA staff infection control education should include the following:

• Information on appropriate use, transport, storage, and cleaning methods of patient care equipment according to manufacturer guidelines/instructions for use; • Job-specific, infection prevention education and training to all health care personnel for all of their respective tasks; • Processes to ensure that all health care personnel understand and are competent to adhere to infection prevention requirements as they perform their roles and responsibilities; • Written infection prevention policies and procedures that are widely available, current, and based on current standards of practice; • Training before individuals are allowed to perform their duties and periodic refresher training as designated by HHA policy; • Additional training in response to recognized lapses in adherence and to address newly recognized infection transmission threats (e.g., introduction of new equipment or procedures); • Infection control education provided to staff at periodic intervals consistent with accepted standards of practice. Such education must be provided at orientation, annually, and as needed to meet the staff’s learning needs to provide adequate care; identify infection signs and symptoms; identify routes of infection transmission; appropriately disinfect/sanitize/transport equipment and devices used for patient care; and use proper medical waste disposal techniques. Such education must include instructions on how to implement current infection prevention/treatment practices in the home setting.

Survey Procedures §484.70(c)

• Review the clinical record for evidence of patient/caregiver infection control education pertinent to the patient’s condition and per the plan of care (see also §484.60).

• Ask the staff what training they received in infection control. Based on interview responses, follow up through HHA policy review and training records to ensure evidence of compliance.