The facility must establish an Infection Control Program under which it –

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Infection Control - F441483.65 The facility must establish and maintain an Infection Control Program designed to provide a safe, sanitary and comfortable environment and to help prevent the development and transmission of disease and infection. The facility must establish an Infection Control Program under which it – Investigates, controls, and prevents infections in the facility; Decides what procedures, such as isolation, should be applied to an individual resident; and Maintains a record of incidents and corrective actions related to infections.

Infection Control - F441 (b) Preventing Spread of Infection When the Infection Control Program determines that a resident needs isolation to prevent the spread of infection, the facility must isolate the resident. 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. The facility must require staff to wash their hands after each direct resident contact for which hand washing is indicated by accepted professional practice Personnel must handle, store, process and transport linens so as to prevent the spread of infection.

Infection Control - F441Overview Infections result in an estimated 150,000 to 200,000 hospital admissions per year. When a nursing home resident is hospitalized with a primary diagnosis of infection, the death rate can reach as high as 40%. An effective facility-wide infection prevention and control program can help contain costs and reduce adverse consequences. Critical aspects include: Recognizing and managing infections at the time of a resident’s admission to the facility and throughout their stay Following recognized infection control practices while providing care.

Infection Control - F441Program Development and Oversight Involves: Establishing goals and priorities for the program Planning and implementing strategies to achieve the goals Identify the staff’s roles and responsibilities Develop, train, and implement infection control policies and procedures Monitoring the implementation of the program – includes infection control practices Document the tracking/analyzing outbreaks of infection including the actions taken to resolve related problems Define and manage appropriate health initiative – influenza and pneumonia immunizations, tuberculosis screening Manage food safety, pest control, waste disposal and employee health and hygiene Responding to errors, problems or other identified issues

Infection Control - F441Policy and Procedures Policies and procedures are reviewed periodically and revised as needed to conform to current standards of practice or to address specific facility concerns. Establish the program’s expectations and parameters - i.e.; Specify the use of standard precautions facility-wide and use of transmission-based precautions when indicated Define the frequency and nature of surveillance activities Require staff to use accepted hand hygiene after each direct resident contact for which hand hygiene is indicated Prohibit direct resident contact by an employee who has an infected skin lesion or communicable disease. Procedures guide the implementation of the policies and performance of specific tasks – i.e.; How to identify and communicate information about residents with potentially transmissible infectious agents

Infection Control - F441Policy Policies and procedures are reviewed periodically and revised as needed to conform to current standards of practice or to address specific facility concerns. Establish the program’s expectations and parameters - i.e.; Specify the use of standard precautions facility-wide and use of transmission-based precautions when indicated Define the frequency and nature of surveillance activities Require staff to use accepted hand hygiene after each direct resident contact for which hand hygiene is indicated Prohibit direct resident contact by an employee who has an infected skin lesion or communicable disease.

Infection Control - F441 Procedures Procedures guide the implementation of the policies and performance of specific tasks – i.e.; How to identify and communicate information about residents with potentially transmissible infectious agents How to obtain vital signs for a resident on contact precautions and what to do with the equipment after its use Essential steps and considerations (including choosing agents) for performing hand hygiene

Infection Control - F441Surveillance Essential elements of a surveillance system include: Use of standardized definitions and listings of the symptoms of infection - http://www.apic.org/Professional-Practice/Practice-Resources/Definitions-Surveillance Use of surveillance tools such as infection surveys and data collection templates Walking rounds throughout the facility Identification of segments of the resident populations at risk for infection Identification of the processes or outcomes selected for surveillance Statistical analysis of data that can uncover an outbreak Feedback of results to the primary caregivers so they can assess the residents for signs of infection.

Infection Control - F441Process Surveillance Determines whether the facility - Minimizes exposure to a potential source of infection Uses appropriate hand hygiene prior to and after all procedures Ensures that appropriate sterile techniques are followed when indicated Uses personal protective equipment when indicated Ensures that reusable equipment is appropriately cleaned, disinfected or reprocessed Uses single-use medication vials and other single use items appropriately

Infection Control - F441Outcome Surveillance Consists of – Collecting/documenting data on individual cases and comparing the collected data to standard written definitions (criteria) of infections. Reports describe the types of infections Descriptive documentation provides the facility with summaries of the observed staff practices and/or the investigation of the causes of an infection or trends The IP (Infection Preventionist) or other designated staff reviews data to detect clusters and trends such as antibiotic orders, antibiotic susceptibility profiles, medication regimen review reports, physician progress reports and transfer summaries of newly admitted residents. All residents are monitored for current infections and infection risks Review of outcome data helps the facility to identify the number of residents who develop infections within the nursing home.

Infection Control - F441Education Both initial and ongoing infection control education help staff comply with infection control practices. Essential topics of infection control training include: Routes of disease transmission Hand hygiene Sanitation procedures MDROs (multi-drug resistant organisms) Because of increases in MDROs, review of the use of antibiotics (including comparison of prescribed antibiotics with available susceptibility reports) is a vital aspect of the prevention and control program Transmission-based precaution techniques Federally required OSHA education

Infection Control - F441Preventing the Spread Modes of transmission include - Contact Droplet Airborne

Infection Control - F441Factors of the Spread Individual Corticosteroids and chemotherapy Decreased function of the heart, lungs and kidneys Decreased/absent cough reflex, thinning skin, decreased tear production, vascular insufficiency, impaired immune function Coexisting chronic diseases – diabetes, cancer, COPD, anemia Institutional Pathogen exposure in shared communal living space – handrails & equipment Common air circulation Transfer of residents to and from hospitals or other settings Improper hand hygiene, improper glove use, improper food handling

Infection Control - F441Factors of the Spread Direct transmission (Person to Person) Contaminated hands of staff are often implicated Examples include (but not limited to) - MRSA, VRE, and Influenza Indirect transmission Resident care devices – thermometers or glucose monitoring devices Clothing, uniforms, lab coats etc., i.e. – MRSA, VRE, Clostridium difficile Toilets and bedpans, i.e. – salmonella, shigella, E. coli, norovirus and C-diff. Reducing and/or preventing infections through indirect contact requires the decontamination (cleaning, sanitizing, or disinfecting) of resident equipment, medical devices, and the environment.

Infection Control - F441Factors of the Spread Critical items – equipment must be sterile when used such as needles, intravenous catheters, indwelling urinary catheter.s Semi-critical items – equipment that require meticulous cleaning followed by high-level disinfection tx or sterilized such as thermometers, podiatry equipment, electric razors. Non-critical items – equipment that require low level disinfection by cleaning periodically and after visible soiling with an EPA disinfectant detergent or germicide such as stethoscopes, blood pressure cuffs, over-bed tables. Single dose/single use equipment is an alternative to sterilizing medical instruments. They must be discarded after use and are never used for more than one resident.

Infection Control - F441Factors of the Spread Single dose/single use medications – must not be used for multiple residents due to the risk of spreading infections diseases. Medications labeled as single-use or single dose by manufacturers typically lack antimicrobial preservatives and once a SDV is entered, the contents can support the growth of micro-organisms. The risk of infection transmission associated with using SDVs for multiple residents is well documented, with evidence accumulated from the investigation of multiple outbreaks. Administering drugs from on SDV to multiple residents without adhering to USP standards is not acceptable.

Infection Control - F441Factors of the Spread Insulin Pens are designed to permit self-injection and are intended for single-person use, using a new needle for each injection. Insulin pens are designed to be used multiple times by a single resident only and must never be shared. Insulin pens must be clearly labeled with the resident’s name or other identifiers to verify that the correct pen is used for the correct resident. Policy and procedures and staff education should be provided when facility’s use insulin pens. If it is discovered that insulin pens are shared between residents, the facility’s plan of correction should include notification of the local health department.

Infection Control - F441Linens It is important that all potentially contaminated linen be handled with appropriate measures to prevent cross-transmission. If the facility handles all used linen as potentially contaminated (i.e., using standard precautions), no additional separating or special labeling of the linen is recommended. No special precautions (double bagging) or categorizing is recommended for linen originating in isolation rooms. Double bagging of linen is only recommended if the outside of the bag is visibly contaminated or is observed to be wet through to the outside of the bag. Leak-resistant bags are recommended for linens contaminated with blood or body substances. For the routine handling of contaminated laundry, minimum agitation is recommended to avoid the contamination of air, surfaces, and persons. It is important that laundry areas have hand washing facilities and products (PPE) available for workers to wear while sorting linens. It is recommended that damp linen is not left in machines overnight.

Infection Control - F441Linens The CDC recommends leaving washing machines open to air when not in use to allow the machine to dry completely and to prevent growth of microorganisms in wet, potentially warm environments. Laundry detergents used within facilities are not required to have state anti-microbial claims. Facilities should closely follow manufacturer’s instructions for laundry detergents used. CMS and CDC have determined that ozone cleaning systems are acceptable methods of processing laundry. Ozone cleaning systems also should be used per manufacturer’s instructions. An effective way to destroy microorganisms in laundry items is through hot water washing at temps about 160 degrees Fahrenheit (F) for 25 minutes. Alternatively, low temp washing at 71-77 degrees F plus a 125-part-per-million (ppm) chlorine bleach rinse has been found to be effective and comparable to high temperature wash cycles.

Infection Control - F441Linens Laundry washing within facilities typically occurs in a low water temperature environment. Many laundry items are composed of materials that cannot withstand a chlorine bleach rinse and remain intact. A chlorine beach rinse is not required for all laundry items processed in low temperature washing environments due to the availability of modern laundry detergents that are able to produce hygienically clean laundry without the presence of chlorine beach. However, a chlorine bleach rinse may still be used for laundry items composed of materials such as cottons.

Infection Control - F441Linens Hot water washing at temps greater than 160 degrees F for 25 minutes and low temp washing at 71 to 77 degrees F with a 125 ppm chlorine bleach rinse continue to be effective ways to wash laundry. If a facility chooses to process laundry using a hot water temp environment, the temp maintained for 25 minutes should be at or about 160 degrees F. Facilities are not required to maintain a record of water temps during laundry processing cycles. Facilities are required to follow manufacturer’s instructions for all material involved in laundry processing. Facilities should consider resident’s individual needs (allergies) when selecting methods for processing laundry.

Infection Control - F441Linens If linen is sent off to a professional laundry, the facility should obtain an initial agreement that stipulate the laundry will be hygienically cleaned and handled to prevent recontamination from dust and dirt during loading and transport. An ozone laundry cleaning system is a method which may require a professional laundry service. The facility will need to obtain such an agreement. Whether laundry processing is completed within or outside the facility, facilities should have written policies & procedures which should include training for staff who will handle linens and laundry.

Infection Control - F441Linens Regarding standard mattresses and pillows - patches for tears and holes in mattress covers do not provide an impermeable surface over a mattress – therefore it is recommended that mattress covers with tears/holes be replaced. - And it is recommended that moisture resistant mattress covers be cleansed and disinfected between residents with an EPA approved germicidal detergent to help prevent the spread of infections and fabric mattress covers be laundered in a hot water laundry cycle between residents.

Infection Control - F441Recognizing and Containing Outbreaks It is important that facilities know how to recognize and contain infectious outbreaks. An outbreak is typically one or more of the following: One case of an infection that is highly communicable; Trends that are 10% higher than the historical rate of infection for the facility that may reflect an outbreak or seasonal variation and therefore warrant further investigation; or Occurrence of three or more cases of the same infection over a specified length of time on the same unit or other defined areas.

Infection Control - F441MDRO’s MDRO’s found in facilities include (but not limited to) MRSA – Methicillin resistant staphylococcus aureus VRE – Vancomycin resistant enterococcus C. Diff - Clostridium difficile Transmission-based precautions are employed for residents who are actively infected with a MDRO.

Infection Control - F441MDRO’s Staphylococcus is a common cause of infections in hospitals and nursing homes and increasingly in the community. Common sites of MRSA colonization include the rectum, perineum, skin and nares. Colonization may precede or endure beyond an acute infection. MRSA is transmitted (most commonly) by person to person and on inanimate objects (i.e. stethoscopes etc) *MRSA infection is commonly treated with vancomycin – which, in turn can lead to increased enterococcus antibiotic resistance.

Infection Control - F441MDRO’s C. Difficile is an organism which normally lives benignly in the colon in spore form. When antibiotic use eradicates normal intestinal flora, the organism may become active and produce a toxin that causes symptoms such as diarrhea, abdominal pain, and fever. More severe cases can lead to additional complications such as intestinal damage and severe fluid loss. Treatment options include stopping the antibiotics and starting specific anticlostridial antibiotics such as metronidazole (flagyl) or oral vancomycin. Contact precautions are instituted for residents with symptomatic C. difficile infection.

Infection Control - F441Intravascular devices Devices such as central venous catheters, PICC lines, dialysis catheters etc. may increase the risk for local and systemic infections. Surveillance consistently includes all residents with vascular access to reduce risk for infection. What does this mean? Observation of the insertion sites Observation of the dressing changes Observation for use of appropriate PPE and hand hygiene during the care and tx of residents with venous catheters. Review of medical record for evidence of infection

Infection Control – F441Surveyor Investigative Protocol Observations Linens handled in manner to prevent contamination Employees with cold symptoms, infections or open lesions on hands are prohibited from contact with resident(s) & food Adherence to infection control practices – use of PPE Hand hygiene and use of gloves when indicated Availability of gloves and products to perform hand hygiene Residents with S&S of infections Cleaning and disinfecting practices

Infection Control – F441Surveyor Investigative Protocol Interview(s) of Direct care staff concerning; Whether they are aware of and have reported any signs/symptoms exhibited by the resident that may be associated with an infection Whether they have been instructed on any special precautions that are applicable to a resident on transmission based precautions How staff know which residents are covered by transmission-based precautions and, what specific actions are required for each type of transmission based precautions.

Infection Control – F441Surveyor Investigative Protocol Record Review Resident’s medical record reveals an evaluation of factors which may increase the risk of infection (i.e. – urinary catheters, trache tube etc.) and if an infection is present, documentation indicating potential causes/contributing factors Resident’s plan of care includes interventions to prevent transmission of infection when applicable Surveillance records reflect pertinent data – date of infection, sign/symptoms meet criteria of infection, treatment ordered, precautions implemented, date resolved, review of antibiotic appropriateness/effectiveness Infection control policies meet current professional standards of practice and are defined by departments i.e. – nursing, dietary, laundry

Infection Control - 441Criteria for Compliance This is determined if the program/facility demonstrates; Ongoing surveillance, recognition, investigation and control of infections to prevent the onset and the spread of infection; Practices to reduce the spread of infection and control of transmission-based precautions; Practices and process consistent with infection prevention and prevention of cross-contamination (i.e. -catheter care etc.); That it uses records of incidents to improve its infection control processes and outcomes by taking corrective action; Processes and procedures to identify and prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food; Consistent adherence with appropriate hand hygiene practices; Handling, storage, processing and transporting of linens so as to prevent the spread of infection.

Infection Control - 441Deficiency Categorization Severity Level 2 - indicates noncompliance that results in a resident outcome of no more than minimal discomfort and/or has the potential to compromise the resident’s ability to maintain or reach his or her highest practicable level of well being. The potential exists for greater harm to occur if interventions are not provided. The facility failed to ensure that their staff demonstrates proper hand hygiene between residents to prevent the spread of infections. The staff administered medications to a resident via a gastric tube and while wearing the same gloves, proceeded to administer oral medications to another resident. The staff did not remove the used gloves and wash or sanitized their hands between residents. The facility failed to implement a surveillance program including the investigation of infections or attempt to distinguish facility-acquired infections from community-acquired infections. The facility identified issues related to staff infection control practice but failed to identify the cause and institute measures to correct the problem

Infection Control - 441Deficiency Categorization Severity Level 3 - indicates noncompliance that results in actual harm that is not immediate jeopardy. The facility routinely sent urine cultures of asymptomatic residents with indwelling catheters, putting residents with positive cultures on antibiotics, resulting in two residents acquiring antibiotic-related colitis and significant weight loss. The facility failed to institute internal surveillance for adherence to hand washing procedures or pertinent reminders to staff regarding appropriate respiratory precautions during an influenza outbreak resulting in additional cases of influenza in residents on another, previously unaffected unit or section of the facility.

Infection Control - 441Deficiency Categorization Severity Level 4 – immediate jeopardy is a situation… likely to result in serious injury, harm, impairment, or death to a resident AND requires immediate correctionetc. The facility failed to restrict a staff member with a documented open, draining and infected skin lesion that was colonized with MRSA from working without adequately covering the area, resulting in MRSA transmission and infection of one or more residents under that staff person’s care. The facility failed to investigate, document surveillance of and try to contain an outbreak of gastrointestinal illness among residents; as a result, additional resident became ill.

Infection Control - 441Summary Statement of Deficiency On …. at 4:06pm, facility staff nurse (A) was observed using an ultra trak ultimate glucometer to place a blood tinged test strip into the device for a serum blood glucose reading for resident #20. Upon leaving resident #20’s room, staff nurse (A) failed to disinfect the glucometer and placed it back into the treatment cart. Then staff nurse (A) went to resident #21’s room. Taking out the same glucometer used for resident #20 serum glucose measurement from the treatment cart, staff nurse (A) then inserted a blood tinged test strip into the glucometer for a serum glucose measurement. After use of the glucometer, staff nurse (A) then placed the glucometer into the top right drawer of the treatment care without disinfecting it. At 4:25pm (same date), staff nurse (A) removed the same ultra trak ultimate glucometer from the treatment cart use for resident #21 and place a blood tinged test strip into it for measuring resident #3’s serum glucose level. Staff nurse (A) failed to sanitize this glucometer prior to and after use on resident #3.

Infection Control - 441Summary Statement of Deficiency An observation of pericare for Resident #X on x/xx/xx at 3:00pm Certified Nurse Aide (CNA) entered with Resident #X into her room. CNA did not wash hands prior to applying gloves before transferring Resident #X into her bed. When Resident #X was in bed, CNA, with same gloves on, checked Resident #X’s brief to check if Resident #X was soiled. CNA stated that Resident #X would need to be changed. CNA then with same gloved hands, proceeded to Resident #X’s closet to retrieve a clean brief. CNA removed gloves and left the room without washing hands to get washcloths. CNA returned to room without washing hand to and applied clean gloves, filled wash basin, and retrieved Resident#4’s body wash from her bedside stand. CNA placed the wash basin directly on Resident #X’s bedside table….CNA removed gloves, and without washing hands, applied clean gloves and proceeded to clean Resident #X back side. Once Resident #X pericare was complete and a clean brief applied, CNA went across room and with gloved hand turned on air conditioner for room….

Infection Control - 441Summary Statement of Deficiency …during an observation of the dressing change to Resident #x’s right heel on X/XX/XX at X:XX pm, Assistant Director of Nursing was observed with gloved hands to remove the dressing from Resident #X’s right heel, then, with her right gloved hand, reached into her left pocket to get a measuring tool to measure Resident #X’s heel ulcer.

Infection Control - 441Summary Statement of Deficiency …An interview was conducted with the Director of Nursing (DON) on 7/23/14 at 9:00am, pertaining to the Infection Control Program. A review of the Infection Control Program documentation from April 2013 through July XX, 2014 revealed: No “Employee Infection Logs” No documentation showing employee illnesses were monitored and compared with resident infections in the monthly summaries No monthly summaries showing infection control information gathered had been analyzed with appropriate recommendations to prevent the potential spread of infectious organisms. The maps of the facility showing the locations of residents with infections by color-coding was not consistently completed to include all of the infections…

Let’s take a pause here for any questions or comments regarding the Infection Control tag – F441

Accidents – F323483.25 (h)(1)(2) The facility must ensure that the resident remains as free from accident hazards as is possible; and each resident receives adequate supervision and assistance devices to prevent accidents. The intent of this requirement is to ensure the facility provides an environment that is free from accident hazards over which the facility has control and provides supervision and assistive devices to each resident to prevent avoidable accidents. This includes: Identifying, evaluating and analyzing hazards and risks Implementing interventions to reduce the hazards and risks Monitoring for effectiveness and modifying interventions as necessary

Accidents – F323Definitions “Accident” – refers to any unexpected or unintentional incident which may result in injury or illness to a resident. (This does not include adverse outcomes that are a direct consequence of treatment or care that is provided in in accordance with current standards of practice, i.e. drug side effects). “Avoidable Accident” – means that an accident occurred because the facility failed to identify environmental hazards and individual resident risk of an accident including the need for supervision, and/or failed to implement intervention, including adequate supervision, consistent with a resident’s needs, goals, plan of care and current standards of practice in order to reduce the risk of an accident and/orfailed to monitor for effectiveness and modify interventions as necessary. “Unavoidable Accident” – means that an accident occurred despite facility efforts to identify, evaluate and analyze the hazards and risks, and to implement interventions to reduce the hazards and risks, andto monitor for effectiveness and modify interventions as necessary.

Accidents – F323 “Assistance Device” or “Assistive Device” – refers to any item (handrails, grab bars, transfer lifts, canes, wheelchairs etc.) that is used by, or in the care of a resident to promote, supplement, or enhance the resident’s function and/or safety. “Fall” – refers to unintentionally coming to rest on the ground, floor, or other lower level, but not as a result of an overwhelming external force i.e. – resident pushes another resident. An episode where a resident lost their balance and would have fallen, if not for staff intervention, is considered a fall. A fall without injury is still a fall. Unless there is evidence suggesting otherwise, when a resident is found on the floor, a fall is considered to have occurred. “Hazards” – refer to element of the resident environment that have the potential to cause injury or illness.

Accidents – F323Definitions “Free of accident hazards as is possible” – refers to being free of accident hazards over which the facility has control. “Supervision/Adequate Supervision” – refers to an intervention and means of mitigating the risk of an accident. Facilities are obligated to provide adequate supervision to prevent accidents.

Accidents – F323Overview Numerous and varied accident hazards exist in everyday life. It is important that all facility staff understand the facility’s responsibility, as well as their own, to ensure the safest environment possible for residents. The facility is responsible for providing care to residents in a manner that helps promote quality of life. This includes respecting residents’ rights to privacy, dignity and self determination, and their right to make choices about significant aspects of their life in the facility. The responsibility to respect resident’s choices is balanced by considering the potential impact of these choices on other individuals and the facility’s obligation to protect the residents from harm.

Accidents – F323Identification of Hazards and Risks Identification of Hazards and Risks - sources may include; Quality assurance activities Environmental rounds MDS/CAAs data Medical history and physical exam Individual observation This information is to be documented and communicated across all disciplines.

Accidents – F323Evaluation and Analysis Evaluation and Analysis - may include; Considering the severity of hazards The immediacy of risk Trends such as time of day, location etc.

The facility must establish an Infection Control Program under which it –