Infection Control and Barrier Precautions

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Introduction   

Healthcare professionals have the responsibility to adhere to scientifically accepted principles and practices of infection control in all healthcare settings and to oversee and monitor those medical and ancillary personnel for whom the professional is responsible. 

The following sections explore the sources and definitions of standards of professional conduct as they apply to infection prevention and control.  

Element I 

Rules of the Board of Regents, Part 29.2 (a)(13) 

New York (NY) law clearly defines the responsibilities of health professionals in having access to products, using, and adhering to scientifically approved techniques for “. . . the cleaning and sterilization or disinfection of instruments, devices, materials and work surfaces, utilization of protective garb, use of covers for contamination-prone equipment and the handling of sharp instruments” (1).  

These guidelines and rules are laid out within the Rules of the Board of Regents, Part 29.2 (a)(13). It is the responsibility of nursing to review and execute these standards throughout the healthcare continuum as follows (1): 

1. Wearing appropriate protective gloves at all times when touching blood, saliva, other body fluids or secretions, mucous membranes, non-intact skin, blood-soiled items or bodily fluid-soiled items, contaminated surfaces, and sterile body areas, and during instrument cleaning and decontamination procedures. 
2. Discarding gloves used following treatment of a patient and changing to new gloves if torn or damaged during treatment of a patient; washing hands and donning new gloves before performing services for another patient; and washing hands and other skin surfaces immediately if contaminated with blood or other body fluids. 
3. Wearing appropriate masks, gowns or aprons, and protective eyewear or chin-length plastic face shields whenever splashing or spattering of blood or other body fluids is likely to occur. 
4. Sterilizing equipment and devices that enter the patient’s vascular system or other normally sterile areas of the body. 
5. Sterilizing equipment and devices that touch intact mucous membranes but do not penetrate the patient’s body or using high-level disinfection for equipment and devices that cannot be sterilized before use for a patient. 
6. Using appropriate agents, including but not limited to detergents for cleaning all equipment and devices before sterilization or disinfection. 
7. Cleaning, by the use of appropriate agents, including but not limited to detergents, equipment, and devices that do not touch the patient or that only touch the intact skin of the patient. 
8. Maintaining equipment and devices used for sterilization according to the manufacturer’s instructions. 
9. Adequately monitoring the performance of all personnel, licensed or unlicensed, for whom the licensee is responsible regarding infection control techniques. 
10. Placing disposable used syringes, needles, scalpel blades, and other sharp instruments in appropriate puncture-resistant containers for disposal; and placing reusable needles, scalpel blades, and other sharp instruments in appropriate puncture-resistant containers until appropriately cleaned and sterilized. 
11. Maintaining appropriate ventilation devices to minimize the need for emergency mouth-to-mouth resuscitation. 
12. Refraining from all direct patient care and handling of patient care equipment when the health care professional has exudative lesions or weeping dermatitis, and the condition has not been medically evaluated and determined to be safe or capable of being safely protected against in providing direct patient care or in handling patient care equipment; and 
13. Placing all specimens of blood and body fluids in well-constructed containers with secure lids to prevent leaking, and cleaning any spill of blood or other body fluid with an appropriate detergent and appropriate chemical germicide 
14. Part 92 of Title 10 (Health) of the Official Compilation of Codes, Rules, and Regulations of New York 

Under Part 92 of Title 10, it is the responsibility of healthcare professionals who are in a position of providing direct care or providing supervision over staff providing direct patient care to maintain competency in infection prevention and barrier precautions. The requirement is fulfilled via a New York board-approved coursework or training.  Coursework or training must be before initial licensing, subsequently renewed every four years, and maintained for six years after ceasing position or such work (2). 

Statements of Relevant Professional and National Organizations 

As the largest healthcare workforce in the nation, nurses are in a position to positively affect the rates of infection at the bedside. The Center for Disease Control asserts the minimum accepted practice of preventing infection is with the use of Standard Precautions, with the number one action in prevention being proper hand washing (3). 

The American Nurses Association refers to similar basic tenets of infection prevention: thorough hand washing; staying home when ill; ensuring vaccinations are complete and up to date; using appropriate personal protective equipment; and covering the face when coughing or sneezing (4). 

In 2017, the CDC, ANA, and 20 other professional nursing organizations collaborated to create the Nursing Infection Control Education (NICE) Network. This team effort is aimed at introducing clear obligations and competencies for nursing and all healthcare providers to stop the spread of microorganisms within healthcare systems. Within these cores is the responsibility of nurses as leaders within healthcare, “To be successful, infection prevention programs require visible and tangible support from all levels of the healthcare facility’s leadership” (5). 

Implications of Professional Conduct Standards 

As healthcare professionals who participate in and supervise the care of patients, nurses are responsible for being knowledgeable of the guidelines set by State and federal bodies. Several of these will be touched on throughout this course. 

The responsibility also applies to delegated activities. The nurse must ensure that the five rights of delegation are considered when assigning a task to unlicensed assistive personnel and that appropriate infection control policies and protocols are being followed appropriately. Always refer to facility policies and procedures to avoid potentially adverse outcomes. 

Failure to follow the accepted standards of infection prevention and control may have serious health consequences for patients, as well as healthcare workers. Hospital acquired infections (HAI) have increased overall from 2020 to 2021 in all infections including central line-associated bloodstream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), ventilator-associated infections, and methicillin-resistant staphylococcus aureus (MRSA). Only clostridium difficile (C-Diff) and surgical site infections (SSI) saw rates lower (6). 

In cases of nurses observing incompetent care or unprofessional conduct in relation to infection control standards, the chain of command should first be utilized. Taking consideration into the type of misconduct, the infection control violation should be addressed according to facility policy. Charge nurses and managers would be wise to first address the issue with the nurse involved to gather information and address any education deficits. 

In cases where clear misconduct is evident, the National Council of State Boards of Nursing provides advice, “A nurse’s practice and behavior is expected to be safe, competent, ethical and in compliance with applicable laws and rules. Any person who has knowledge of conduct by a licensed nurse that may violate a nursing law or rule, or related state or federal law may report the alleged violation to the board of nursing where the conduct occurred” (7). 

The New York Board of Nursing can be reached via its website or at (518) 474-3817. The mailing address is Education Bldg., 89 Washington Avenue, 2nd Floor West Wing, Albany, NY 12234. 

The consequences of failing to follow accepted standards of infection prevention and control may result in a complaint investigation from New York’s Professional Misconduct Enforcement System. Upon investigation, penalties include but are not limited to reprimand and censure, fines of up to $10,000 per violation, and probationary terms. 

Severe misconduct may result in the loss or revocation of a nursing license. Also, in cases where the neglect to follow appropriate conduct has resulted in harm to a patient or co-worker, there is potential for professional liability through a malpractice suit brought against the nurse. 

Methods of Compliance 

Nurses are responsible for being knowledgeable of the licensure guidelines, renewal CEs, and targeted education in their state of practice. Refer to the NY Board of Nursing for further guidance beyond the above-mentioned licensing requirements. 

Education of infection control best practices, complying with state requirements, and following the facility practices and policies will provide the best protection for self, patients, and staff in preventing and controlling infection during patient care. 

Element II 

Modes and mechanisms of transmission of pathogenic organisms in the healthcare setting and strategies for prevention control. 

Definitions 

Pathogen or infectious agent: A biological, physical, or chemical agent capable of causing disease. Biological agents may be bacteria, viruses, fungi, protozoa, helminths, or prions. 

Portal of entry: How an infectious agent enters the susceptible host. 

Portal of exit: The path by which an infectious agent leaves the reservoir. 

Reservoir: A place in which an infectious agent can survive but may or may not multiply or cause disease. Healthcare workers may be a reservoir for a number of nosocomial organisms spread in healthcare settings. 

Standard precautions: A group of infection prevention and control measures that combine the major features of Universal Precautions and Body Substance Isolation and are based on the principle that all blood, body fluids, secretions, excretions except sweat, non-intact skin, and mucous membranes may contain transmissible infectious agents. 

Susceptible host: A person or animal not possessing sufficient resistance to a particular infectious agent to prevent contracting infection or disease when exposed to the agent. 

Transmission: Any mechanism by which a pathogen is spread by a source or reservoir to a person. 

Common vehicle: Contaminated material, product, or substance that serves as a means of transmission of an infectious agent from a reservoir to one or more susceptible hosts through a suitable portal of entry. 

Component of the Infectious Disease Process 

The infectious disease process follows a particular sequence of events that is commonly described as the “Chain of Infection.” Nurses must have a solid understanding of this process in order to identify points in the chain where the spread of infection may be prevented or halted.  

The sequence involves six factors: pathogen, reservoir, portal of exit, portal of entry, mode of transmission, and a susceptible host. The cyclical and consistent nature of the chain provides many opportunities to utilize scientific, evidence-based measures in combating infection spread. 

Pathogens within healthcare are widespread and plentiful, putting patients and healthcare workers at particular risk for contamination. The manifestation of symptoms and mode of transmission varies depending upon the characteristics of the specific infectious agent.  

Healthcare workers are at a considerably higher risk for bloodborne pathogens such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus. Influenza, methicillin-resistant Staphylococcus aureus (MRSA), and Tuberculosis (TB) also pose a higher risk (1). Due to the immunocompromised systems of patients, these and many other pathogens cause a considerable risk and can result in HAIs such as Central Line-associated Bloodstream Infection (CLABSI), Catheter-associated Urinary Tract Infections (CAUTI), Surgical Site Infection (SSI), and Ventilator-associated Pneumonia (VAP) (1). 

Pathogens require a reservoir, which is typically a human or animal host; however, may also be from the environment, such as standing water or a surface. From the reservoir, the pathogen is spread via a mechanism such as body fluid, blood, and secretions.  

Common sites for contact within patient care include the respiratory, genitourinary, and gastrointestinal tracts, as well as skin/mucous membranes, transplacental, or blood. From here, the mechanism must come into contact with another portal of entry.  

Transmission may occur through respiratory, genitourinary, and gastrointestinal tracts, skin and/or mucous membranes, and parenteral pathways. Some of these sites may have become compromised during patient care due to percutaneous injury, invasive procedures or devices, or surgical incisions. 

In order to acquire a pathogen, a mode of transmission must be provided. These can be from contact, transmission via a common vehicle, or vector-borne. 

Contact with a pathogen may be categorized as direct, indirect, droplet, or airborne. Contact transmission is through direct or indirect contact with a patient or objects that have been in contact with the patient. Pathogens related to this include Clostridium difficile and multi-drug resistant organisms such as MRSA.  

Droplet transmission occurs when a pathogen is able to infect via droplets through the air by talking, sneezing, coughing, or breathing. The pathogen is able to travel three to six feet from the patient. Airborne transmission occurs when pathogens are 5 micrometers or smaller in size and are capable of being suspended in the air for long periods of time. These types of pathogens include tuberculosis, measles, chickenpox, disseminated herpes zoster, and anthrax (2). 

Transmission may also occur through a common vehicle which affects multiple hosts and can come from food, intravenous fluid, medication, biofilms, or equipment that is shared and often leads to widespread outbreaks. Vector-borne pathogens are derived from living vectors such as mosquitoes, fleas, or ticks. 

The last factor in the chain of infection is a susceptible host with a mode of entry. This is the reason that patients are at a much higher risk for developing secondary infections while within the healthcare system. 

Factors Influencing the Outcome of Exposures 

The human body provides several natural defenses against acquiring infection from a pathogen. The most prominent defense is the integumentary system, and the focus should be on maintaining skin integrity to prevent a mode of entry.  

Respiratory cilia function to move microbes and debris from the airway. Gastric acid is at a pH that prevents the growth of many pathogens. Bodily secretions provide defense through flushing out and preventing back-flow of potential infectious agent colonization.  

The normal flora within the gastrointestinal system also provides a layer of defense that must be protected from the action of antibiotics. Probiotics are commonly administered to patients on antibiotics to prevent a secondary infection due to the normal flora being disrupted (3). 

Host immunity is the secondary defense that utilizes the host’s own immune system to target invasive pathogens. There are four types of host immunity (3): 

1. Inflammatory response is pathogen detection by cells in a compromised area that then elicit an immune response that increases blood flow. This inflammatory provides delivery of phagocytes or white blood cells to the infected site response. Phagocytes are designed to expunge bacteria. 
2. Cell-mediated immunity uses B-cells and T-cells, specialized phagocytes, are cytotoxic cells that target pathogens. 
3. Humoral immunity is derived from serum antibodies produced by plasma cells. 
4. Immune memory is the ability of the immune system to recognize previously encountered antigens of pathogens and effectively initiate a targeted response. 

Pathogen or Infection Agent factors 

For each type of infectious agent, there are specific factors that determine the risk to the host. Infectivity refers to the number of exposed individuals that become infected. Pathogenicity is the number of infected individuals that develop clinical symptoms and virulence is the mortality rate of those infected. The probability of an infectious agent causing symptoms depends upon the size of the inoculum (amount of exposure), and the route and duration of exposure (4). 

The environment is another factor that warrants attention in limiting the probability of exposure in the healthcare setting. Fomites are materials, surfaces, or objects that are capable of harboring or transmitting pathogens. These can be bedside tables, scrubs, gowns, bedding, faucets, and any other number of items that are in contact with patients and healthcare providers (7). 

Equipment may factor into the spread of infection, especially portable medical equipment that can come into contact with numerous patients in a day. This can include vitals machines, IV pumps, wheelchairs, and computers on wheels, among numerous other care items frequently used.  

Care must be taken to ensure cleaning in between each patient’s use. For patients in isolation precautions, dedicated equipment for that patient should remain in the room for the duration of their stay. 

Methods to Prevent the Spread of Pathogenic Organisms  

Standard Precautions 

Standard precautions are the minimal amount of caution and procedure applied to typical patient care. According to the CDC, standard precautions are to be used in all patient care areas with critical thinking applied to “. . . common sense practices and personal protective equipment use” (5).  The primary of these is proper hand hygiene to be exercised by healthcare providers, patients, and visitors. This will be covered in detail further in this course. 

Standard precautions provide guidelines for respiratory hygiene and cough etiquette. The CDC recommends that the mouth and nose be covered with a tissue when coughing or sneezing, with appropriate disposal of the tissue in the nearest waste station. Hand hygiene is to be performed after contact with any respiratory secretions or potentially contaminated items (5). 

As mentioned, healthcare workers are at a higher risk for bloodborne infections due to the handling of sharps. Approximately 385,000 needle sticks and sharps injuries are reported by healthcare workers in hospital settings each year (5). Standard precautions can be applied to ensure safe injection practices and will be further covered in Element III. 

Certain spinal procedures that access the epidural or subdural space provide a means of transmission for infections such as bacterial meningitis. The CDC states (all from 6): 

• Face masks should always be used when injecting material or inserting a catheter into the epidural or subdural space. 

• Aseptic technique and other safe injection practices (e.g., using a single-dose vial of medication or contrast solution for only one patient) should always be followed for all spinal injection procedures. 

For Patients Infected with Organisms Other Than Bloodborne Pathogens 

Special considerations must be given to patient populations that are infected with organisms other than bloodborne pathogens. During the triage of a patient entering a facility, a thorough history should be obtained.  

This would include exposure to infectious agents, travel to certain countries in the world, and previous infections that are resistant to antibiotics (i.e., MRSA, VRE, or carbapenem-resistant Enterobacteriaceae). Patients who are identified with a risk or history of any of these pathogens may be placed on the appropriate precautions in an isolation room.  

Infection prevention and the attending physician should be consulted immediately for further orders and treatment. 

Control of Routes of Transmission 

Controlling the routes of transmission is a key factor in preventing infection spread. Hand hygiene has been established as the primary prevention method.  

Care must be taken to follow guidelines for proper hand washing including: 

• Use antibacterial soap and water when hands are visibly soiled or when a Clostridium difficile infection is known or suspected. 
• Hands should be lathered ensuring all surfaces, between fingers, and under nails are covered with scrubbing lasting at least 20 seconds. 
• Thoroughly rinse the soap from your hands with running water, pat dry with a paper towel, and use a paper towel to turn off the faucet. 
• Hand sanitizer that is at least 60% alcohol based may be used in between soap and water use. 
• A dime-sized amount of hand sanitizer should be rubbed over the surface of hands and fingers, then allowed to air dry. 

Barriers to proper hand hygiene include knowledge gaps and the availability of appropriate supplies. Training programs to educate healthcare providers on proper hand washing should be accompanied with ongoing assessment and feedback to ensure that compliance is met.  

Incorporating hand hygiene into the professional development plan of each nurse is also recommended (7). Healthcare facilities should be diligent in ensuring that hand washing stations are located in convenient areas and that hand cleaning product is frequently monitored and refilled (7,8). Signage and educational materials may be posted in high-traffic areas and at hand washing stations to encourage use by healthcare providers, patients, and visitors (7). 

Nurses and healthcare personnel must be aware of the potential of hand hygiene materials as being a potential source of contamination or cross-contamination. Hand hygiene dispensers are touched frequently with contaminated hands and must be frequently cleaned. Follow the manufacturer’s recommendations for cleaning. 

Hand hygiene systems that allow products to be refilled pose a risk of contaminating the contents. If refilling is a requirement, this should be accomplished using an aseptic technique as much as possible. Facilities should avoid purchasing this type of product and move to pre-filled dispensing units, if possible (10). 

Use of Appropriate Barriers 

Appropriate barriers are essential in keeping patients and healthcare providers safe from transmitting or contracting pathogens. The type of PPE chosen depends on certain variables such as the patient care being provided, standard precautions, and transmission-based precautions. The minimal amount of PPE recommended are as follows: 

Contact precautions require gloves and gowns. If bodily secretions may be contacted, a mask and eye protection are required. 

Droplet precautions require a surgical mask. 

Airborne precautions require the wearing of gloves and a gown as well as an approved N95 respirator mask that has been fit tested for the individual wearing. Negative pressure rooms that are able to filter 6 to 12 air exchanges per hour are also recommended (1). 

Be mindful that these are the minimal recommendations based solely on the identified transmission status of the patient. Selection of PPE should be made using critical thinking to identify potential risks depending on the type of patient care being performed, procedure, behavioral considerations, and other factors that may deviate from the standard. 

The following are current recommendations from the CDC for donning and doffing (11): 

How to Put On (Don) PPE Gear: More than one donning method may be acceptable. Training and practicing using your healthcare facility’s procedure is critical. Below is one example of donning. 

1. Identify and gather the proper PPE to wear. Ensure the choice of gown size is correct (based on training). 
2. Perform hand hygiene using hand sanitizer. 
3. Put on an isolation gown. Tie all of the ties on the gown. Assistance may be needed by other healthcare personnel. 
4. Put on NIOSH-approved N95 filtering face-piece respirator or higher (use a facemask if a respirator is not available). If the respirator has a nosepiece, it should be fitted to the nose with both hands, not bent or tented. Do not pinch the nosepiece with one hand. The respirator/facemask should be extended under the chin. Both your mouth and nose should be protected. Do not wear a respirator/facemask under your chin or store it in a scrubs pocket between patients.  
   1. Respirator: Respirator straps should be placed on the crown of the head (top strap) and base of the neck (bottom strap). Perform a user seal check each time you put on the respirator. 
   2. Face mask: Mask ties should be secured on the crown of the head (top tie) and base of the neck (bottom tie). If the mask has loops, hook them appropriately around your ears.
5. Put on a face shield or goggles. When wearing an N95 respirator or half face-piece elastomeric respirator, select the proper eye protection to ensure that the respirator does not interfere with the correct positioning of the eye protection and that the eye protection does not affect the fit or seal of the respirator. Face shields provide full face coverage. Goggles also provide excellent protection for eyes, but fogging is common. 
6. Put on gloves. Gloves should cover the cuff (wrist) of the gown. 
7. Healthcare personnel may now enter the patient’s room. 

How to Take Off (Doff) PPE Gear: More than one doffing method may be acceptable. Training and practicing using your healthcare facility’s procedure is critical. Below is one example of doffing. 

1. Remove gloves. Ensure glove removal does not cause additional contamination of hands. Gloves can be removed using more than one technique (e.g., glove-in-glove or bird beak). 
2. Remove gown. Untie all ties (or unsnap all buttons). Some gown ties can be broken rather than untied. Do so in a gentle manner, avoiding forceful movement. Reach up to the shoulders and carefully pull the gown down and away from the body. Rolling the gown down is an acceptable approach. Dispose of in a trash receptacle. 
3. Healthcare personnel may now exit the patient’s room. 
4. Perform hand hygiene. 
5. Remove face shields or goggles. Carefully remove face shields or goggles by grabbing the strap and pulling upwards and away from the head. Do not touch the front of your face shield or goggles. 
6. Remove and discard the respirator (or face mask if used instead of respirator). Do not touch the front of the respirator or face mask.  
   1. Respirator: Remove the bottom strap by touching only the strap and bring it carefully over the head. Grasp the top strap, bring it carefully over the head, and then pull the respirator away from the face without touching the front of the respirator. 
   2. Face mask: Carefully untie (or unhook from the ears) and pull away from the face without touching the front. Perform hand hygiene after removing the respirator/face mask and before putting it on again if your workplace is practicing reuse.
7. Perform hand hygiene after removing the respirator/face mask and before putting it on again if your workplace is practicing reuse.

Appropriate Isolation/Cohorting of Patients with Communicable Diseases 

Cohorting patients is a common practice within facilities, especially with limited rooms and an increasing number of patients with MDROs (12). In order to combat these issues, placing patients with the same type of pathogen in one room, when single rooms are not available is an option. The minimal standard for all patients is standard precautions. 

The CDC offers guidance for appropriately isolating or cohorting patients based on the type of precaution. 

Contact: Patients with a known or suspected pathogen that is transmitted via contact should be placed in a private room, if available. Cohorting can be achieved if the cohorted patients share the same type of pathogen (13). 

Droplet: Unless a single patient room is not available, patients in droplet precautions should only be cohorted if neither have an excessive cough or sputum production. The cohorts should be tested to ensure they are infected with the same type of pathogen. Immunocompromised patients are at an increased risk and should not be cohorted. Patients are to be separated at least three feet apart and a privacy curtain should remain drawn between their respective areas. Care providers must don and doff new PPE in between providing care to each respective patient (13). 

Airborne: An airborne infection isolation room (AIIR) with negative air pressure that exchanges air at least six to 12 changes per hour is required. The door must remain closed except for entry and exit. Cohorting of patients is not recommended except in the case of an outbreak or a large number of exposed patients (13). In these instances, the CDC recommends the following (13): 

• Consult infection control professionals before patient placement to determine the safety of alternative rooms that do not meet engineering requirements for AIIR. 
• Place together (cohort) patients who are presumed to have the same infection (based on clinical presentation and diagnosis when known) in areas of the facility that are away from other patients, especially patients who are at an increased risk for infection (e.g., immunocompromised patients). 
• Use temporary portable solutions (e.g., exhaust fan) to create a negative pressure environment in the converted area of the facility. Discharge air directly to the outside, away from people and air intakes, or direct all the air through HEPA filters before it is introduced to other air spaces. 

Host Support and Protection 

Vaccinations to prevent disease are highly recommended by numerous health organizations such as the CDC, the World Healthcare Organization, and the Office of Disease Prevention and Health Promotion. As stated by the U.S. Department of Health and Human Services, “The United States will be a place where vaccine-preventable diseases are eliminated through safe and effective vaccination over the lifespan.” (14).  

As healthcare providers, nurses are in a position to review the patient’s history for gaps in appropriate vaccination coverage and offer education to the patient. Additionally, healthcare providers hold an ethical responsibility to maintain current vaccinations and can prevent transmitting known communicable diseases by receiving an influenza vaccination each year. 

Pre- and/or post-prophylaxis may be recommended during certain types of exposures or for patients at an increased risk for infection. This is commonly used for emergent or planned procedures and surgeries that access areas that are at higher risk for becoming a portal of entry, such as the respiratory, gastrointestinal, and genitourinary tracts. Antibiotics may be ordered when it is known that the sterile field has been broken during a procedure or there has been a concern of contamination of a wound or incision site. 

In cases of exposure to an infectious pathogen, the decision to treat includes factors such as the type of exposure, source of the patient’s symptoms, time frame since exposure, the health status of the individual exposed, as well as the risks and benefits of the treatment. Pre-prophylaxis may be considered in the prevention of HIV for high-risk individuals. 

Typically, after exposure, the host’s blood is drawn to determine pathogen risk regardless of if there is a known pathogen. Post-exposure prophylactics are given within a short time frame from the exposure based on results. The individual who is exposed will have baseline testing for HIV, hepatitis B virus, and hepatitis C viral antibodies. Follow-up testing occurs six weeks, three months, and six months after initial exposure. 

Maintaining skin and immune system integrity is of the utmost importance to prevent the transmission of infectious pathogens.  

Nursing interventions to promote skin and immune system integrity are: 

• Perform a thorough skin assessment every shift and with changes in condition 
• Accurately document any wounds or incisions 
• Use gentle cleansers on the skin and pat dry 
• Use moisturizers and barrier creams on dry or tender skin 
• Prevent pressure ulcer development by turning and repositioning the patient every 2 hours 
• Maintain aseptic technique during wound care, dressing changes, IV manipulation or blood draws, and catheter care 
• Use neutropenic guidelines when providing care to immunocompromised patients 
• Encourage adequate nutritional intake 

Environmental Control Measures 

The cleaning, disinfection, and sterilization of patient care equipment should be performed per the recommendations of the manufacturer. Cleaning should be performed between multiple patients.  

For equipment that has been used in an isolation room, a terminal clean must be performed before being used in any other patient care. Additional information on this topic will be covered within Element V. 

Environmental cleaning personnel must be educated on the appropriate cleaning for all precautionary patient environments. The Material Safety Data Sheets for all chemicals are to be available to all healthcare personnel for reference as to the proper use and storage. These should be referred to in order to ensure that the correct cleaning product is effective in terminally cleaning isolation rooms based on pathogens. 

Ventilation should be thoroughly managed and maintained by the environmental operations team. Negative pressure rooms should be consistently monitored, and alarms investigated to ensure proper air exchange. Concerns from nursing regarding ventilation issues should be directed to the environmental team for follow-up. 

Regulated medical waste (RMW) within the healthcare system that must follow state guidelines for disposal includes: 

• Human pathological waste 
• Human blood and blood products 
• Needles and syringes (sharps) 
• Microbiological materials (cultures and stocks) 
• Other infection waste (16) 

According to the Department of Environmental Conservation in New York, “In accordance with both federal and state requirements, and to ensure containment, RMW (except medical waste sharps) is required to be placed in plastic bags and then packaged in single-use (e.g., corrugated boxes) or reusable rigid (e.g., plastic) or semi-rigid, leak-proof containers before transport. Once packaged, RMW is either transported to a designated secure storage, a collection area within the facility for third party pick-up, or a generator’s on-site treatment facility” (16). 

Bodily fluid (urine, vomit, and feces) may be safely disposed of in any utility sink, drain, toilet, or hopper that drains into a septic tank or sanitary sewer system. Healthcare personnel must don appropriate PPE during disposal. 

Linen and laundry management is governed by Title 10: Section 83-1.17 which states (17) shared health facilities shall: 

• Provide a sufficient quantity of clean linen to meet the requirements of patients. 
• Separately bag or enclose used linens from infectious patients in readily identified containers distinguishable from other laundry. 
• Transport and store clean linen in a manner to prevent contamination. 

Food services are required to follow stringent standards under the New York State Department of Health’s Bureau of Community Environmental Health and Food Protection to ensure that food service establishments are maintained to reduce the incidence of food-borne illness. 

Environment controls include medical devices and systems that are put in place to isolate or remove the blood-borne pathogens hazard from the workplace. These include sharps disposal containers, self-sheathing needles, and safer medical devices, such as sharps with engineered sharps injury protections and needleless systems. Further information will be provided on this subject in Element III. 

Per facility specifications, continuous training and education should be provided to healthcare personnel on the various methods and modes of environmental control measures that are put in place to prevent and contain pathogen spread. 

ELEMENT III 

Use of engineering and work practice controls to reduce the opportunity for patient and healthcare worker exposure to potentially infectious material in all healthcare settings. 

Definitions 

Healthcare-associated infections (HAIs): Infections associated with healthcare delivery in any setting (e.g., hospitals, long-term care facilities, ambulatory settings, home care). 

Engineering Controls: Controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace. 

Injection safety (or safe injection practices): A set of measures taken to perform injections in an optimally safe manner for patients, healthcare personnel, and others. A safe injection does not harm the recipient, does not expose the provider to any avoidable risks, and does not result in waste that is dangerous for the community. Injection safety includes practices intended to prevent transmission of blood-borne pathogens between one patient and another, or between a healthcare worker and a patient, and also to prevent harm such as needlestick injuries. 

b A bottle of liquid medication that is given to a patient through a needle and syringe. Single-use vials contain only one dose of medication and should only be used once for one patient, using a new sterile needle and a new sterile syringe. 

Multi-dose medication vial: a bottle of liquid medication that contains more than one dose of medication and is often used by diabetic patients or for vaccinations. 

Work Practice Controls: Controls that reduce the likelihood of exposure to bloodborne pathogens by altering how a task is performed (e.g., prohibiting the recapping of needles by a two-handed technique). 

High-risk Practices and Procedures 

Percutaneous exposures are a work hazard within the healthcare industry. There are approximately 5.6 million healthcare workers at risk, with nurses ranking number one. Studies have shown that needlestick injuries occur most frequently within a patient room or the operating room (1). 

Exposures can occur through not following safe practices. The following practices in handling contaminated needles and other sharp objects, including blades, can increase the risk of percutaneous exposure and should be avoided: 

1. Manipulating contaminated needles and other sharp objects by hand (e.g., removing scalpel blades from holders, removing needles from syringes) 
2. Delaying or improperly disposing of sharps (e.g., leaving contaminated needles or sharp objects on counters/workspaces or disposing in non-puncture-resistant receptacles) 
3. Recapping contaminated needles and other sharp objects using a two-handed technique 
4. Performing procedures where there is poor visualization, such as: 

• • Blind suturing 
  • Non-dominant hand opposing or next to a sharp 
  • Performing procedures where bone spicules or metal fragments are produced 

Mucous membrane/non-intact skin exposures occur with direct blood or body fluids contact with the eyes, nose, mouth, or other mucous membranes via: 

• Contact with contaminated hands 
• Contact with open skin lesions/dermatitis 
• Splashes or sprays of blood or body fluids (e.g., during irrigation or suctioning) 

Parenteral exposure is the subcutaneous, intramuscular, or intravenous contact with blood or other body fluid. Injection with infectious material may occur during: 

• Administration of parenteral medication 
• Sharing of blood monitoring devices (e.g., glucometers, hemoglobinometers, lancets, lancet platforms/pens) 
• Infusion of contaminated blood products or fluids 
• Human bites, abrasions, or cuts 

According to the CDC, unsafe injection practices have resulted in more than 50 outbreaks of infectious disease transmission since 2001. As well, since that time over 150,000 patients were potentially exposed to HIV, hepatitis B virus, and hepatitis C virus solely due to unsafe practice (2). These deviations from best practice have resulted in one or more of the following consequences: 

• Transmission of blood-borne viruses, including hepatitis B and C viruses to patients 
• Notification of thousands of patients of possible exposure to blood-borne pathogens and recommendation that they be tested for hepatitis C virus, hepatitis B virus, and human immunodeficiency virus (HIV) 
• Referral of providers to licensing boards for disciplinary action 
• Malpractice suits filed by patients 

Pathogens including HCV, HBV, and human immunodeficiency virus (HIV) can be present in sufficient quantities to produce infection in the absence of visible blood. 

• Bacteria and other microbes can be present without clouding or other visible evidence of contamination. 
• The absence of visible blood or signs of contamination in a used syringe, IV tubing, multi- or single-dose medication vial, or blood glucose monitoring device does NOT mean the item is free from potentially infectious agents. 
• All used injection supplies and materials are potentially contaminated and should be discarded. 

Proper infection control techniques require that healthcare providers follow best practices to prevent injury and pathogen transfer. At all times, aseptic techniques should be used to prepare and administer an injection. The following are best practice guidelines: 

1. Medications should be drawn up in a designated “clean” medication area that is not adjacent to areas where potentially contaminated items are placed. 
2. Use a new sterile syringe and needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. 
3. Ensure proper hand hygiene (i.e., hand sanitizing or hand washing if hands are visibly soiled) before handling medications. 
4. If a medication vial has already been opened, the rubber septum should be disinfected with alcohol before piercing it. 
5. Never leave a needle or other device (e.g., “spikes”) inserted into a medication vial septum or IV bag/bottle for multiple uses. This provides a direct route for microorganisms to enter the vial and contaminate the fluid. 
6. Medication vials should be discarded upon expiration or any time there are concerns regarding the sterility of the medication. 

Never administer medications from the same syringe to more than one patient, even if the needle is changed. 

Never use the same syringe or needle to administer IV medications to more than one patient, even if the medication is administered into the IV tubing, regardless of the distance from the IV insertion site. 

1. All of the infusion components from the infusate to the patient’s catheter are a single interconnected unit. 
2. All of the components are directly or indirectly exposed to the patient’s blood and cannot be used for another patient. 
3. Syringes and needles that intersect through any port in the IV system also become contaminated and cannot be used for another patient or used to re-enter a non-patient-specific multidose medication vial. 
4. Separation from the patient’s IV by distance, gravity, and/or positive infusion pressure does not ensure that small amounts of blood are not present in these items. 
5. Never enter a vial with a syringe or needle that has been used for a patient if the same medication vial might be used for another patient. 

Dedicate vials of medication to a single patient, whenever possible. 

1. Medications packaged as single-use must never be used for more than one patient: 
2. Never combine leftover contents for later use 
3. Medications packaged as multi-use should be assigned to a single patient whenever possible. 
4. Never use bags or bottles of intravenous solution as a common source of supply for more than one patient. 
5. Never use peripheral capillary blood monitoring devices packaged for single-patient use on more than one patient: 
6. Restrict the use of peripheral capillary blood sampling devices to individual patients. 
7. Never reuse lancets. Use single-use lancets that permanently retract upon puncture whenever possible. 

Safe injection practices and procedures are designed to prevent disease transmission from patient to healthcare worker. A fact sheet from OHSA can be found here. 

Evaluation/Surveillance of Exposure Incidents 

A plan to evaluate and follow up on exposure incidents should be put into place at every facility. At a minimum, this plan should include the following elements: 

1. Identification of who is at risk for exposure 
2. Identification of what devices cause exposure 
3. Education for all healthcare employees who use sharps. This would include that ALL sharp devices can cause injury and disease transmission if not used and disposed of properly. Specific focus should be on the devices that are more likely to cause injury such as:  
   1. Devices with higher disease transmission risk (hollow bore), and
   2. Devices with higher injury rates (“butterfly”-type IV catheters, devices with recoil action), 
   3. Blood glucose monitoring devices (lancet platforms/pens). 
4. Identification of areas/settings where exposures occur, and 
5. Circumstances by which exposures occur, 
6. Post-exposure management (See Element VI).  

Engineer Controls

Engineer controls are implemented to provide healthcare workers with the safest equipment to complete their jobs. Safer devices should be identified and integrated into safety protocols whenever possible.  

When selecting engineer controls to be aimed at preventing sharps injuries the following should be considered: 

1. Evaluate and select safer devices 
2. Passive vs. active safety features 
3. Mechanisms that provide continuous protection immediately 
4. Integrated safety equipment vs. accessory devices: 
   1. Properly educate and train all staff on safer devices 
   2. Consider eliminating traditional or non-safety alternatives whenever possible 
   3. Explore engineering controls available for specific areas/settings 
5. Use puncture-resistant containers for the disposal and transport of needles and other sharp objects:   
   1. Refer to published guidelines for the selection, evaluation, and use (e.g., placement) of sharps disposal containers.  
   2. National Institute for Occupational Safety and Health (NIOSH) Guidelines 
   3. NYSDOH recommendations “Household Sharps-Dispose of Them Safely”  
   4. Use splatter shields on medical equipment associated with risk-prone procedures (e.g., locking centrifuge lids). 

Work Practice Controls 

1. General practices:  
   1. Hand hygiene including the appropriate circumstances in which alcohol-based hand sanitizers and soap and water hand washing should be used (see Element II) 
   2. Proper procedures for cleaning of blood and body fluid spills 
   3. Initial removal of bulk material followed by disinfection with an appropriate disinfectant 
2. Proper handling/disposal of blood and body fluids, including contaminated patient care items 
3. Proper selection, donning, doffing, and disposal of personal protective equipment (PPE) as trained (see Element IV) 
4. Proper protection of work surfaces in direct proximity to patient procedure treatment area with appropriate barriers to prevent instruments from becoming contaminated with blood-borne pathogens 
5. Preventing percutaneous exposures:  
   1. Avoid unnecessary use of needles and other sharp objects 
   2. Use care in the handling and disposing of needles and other sharp objects:  
   3. Avoid recapping unless medically necessary 
   4. When recapping, use only a one-hand technique or safety device 
   5. Pass sharp instruments by the use of designated “safe zones” 
   6. Disassemble sharp equipment by use of forceps or other devices 
   7. Discard used sharps into a puncture-resistant sharps container immediately after use 

Modify Procedures to Avoid Injury: 

1. Use forceps, suture holders, or other instruments for suturing 
2. Avoid holding tissue with fingers when suturing or cutting 
3. Avoid leaving exposed sharps of any kind on patient procedure/treatment work surfaces 
4. Appropriately use safety devices whenever available:  

• • Always activate safety features 
  • Never circumvent safety features 

ELEMENT IV 

Selection and use of barriers and/or personal protective equipment for preventing patient and healthcare worker contact with potentially infectious material. 

Definitions 

Personal protective equipment (PPE): Specialized clothing or equipment worn by an employee for protection against a hazard. 

Barriers: Equipment such as gloves, gowns, aprons, masks, or protective eyewear, which when worn, can reduce the risk of exposure of the health care worker’s skin or mucous membranes to potentially infective materials. 

Types of PPE/Barriers and Criteria for Selection 

Per OSHA guidelines, employers must provide employees with appropriate PPE that protects them from any potential infectious pathogen exposure (1). PPE includes gloves, cover garb, masks, face shields and eye protection. All PPE is intended to provide a barrier between the healthcare worker and potential contamination, whether from a patient, object, or surface. 

Gloves are intended to provide coverage and protection for hands. There are several types of gloves to choose from and the type of patient care or activity should guide choice. 

• Sterile – to be utilized when performing sterile procedures and aseptic technique 
• Non-sterile – medical grade, non-sterile gloves may be used for general patient care and clean procedures (such as NG tube insertion) 
• Utility – not medical grade and should not be used in patient care 

Choice of material glove is made from is often dictated by cost and facility preference. When given a choice, considerations should be made as to the types of material being handled. 

• Natural rubber latex – rarely used in facilities due to allergen risk 
• Vinyl – made from PVC, lower in cost, provides protection in non-hazardous and low-infection environments 
• Nitrile – more durable, able to withstand chemical and bio-medical exposure (2) 

An appropriately sized glove fits securely to the fingertips and palm without tightness or extra room. If a glove develops a tear or is heavily soiled, it should be replaced immediately. 

Cover garb is a protective layer to wear over scrubs or clothes to protect garments and skin. These include laboratory coats, gowns, and aprons. As with gloves, consideration should be given to size, sterility, type of patient care involved, and material characteristics of the gown. 

• Fluid impervious – does not allow passage of fluids 
• Fluid resistant – resists penetration of fluids, but fluid may seep with pressure 
• Permeable – does not offer protection against fluids 

Masks are intended to provide protection to the wearer’s mouth and nose, with respirators providing an extra layer of protection to the respiratory tract against airborne infection pathogens (1). Goggles are designed to protect the eyes from splashes and droplet exposure, while face shields offer additional protection to the entire face. It is important to note that face shields are not designed to be a replacement for masks. 

The choice of PPE is based on the factors that are reasonably anticipated to occur during the patient care encounter. Potential contact with blood or other potentially infectious material can occur via splashes, respiratory droplets, and/or airborne pathogens.  

The type of PPE chosen will be based on standard or transmission-based precaution recommendations. Follow your facility policy and procedures for guidance on the appropriate choice.  

The nurse will also need to anticipate whether fluid will be encountered, such as emptying a drain or foley collection device. In situations where a large amount of fluid is likely to be encountered, it would be wise to choose a higher level of protection, such as an impermeable gown, if available, and to wear eye protection to ward off splashes. 

Choosing Barriers/PPE Based on Intended Need 

Barriers and PPE are aimed at keeping patients and healthcare providers safe. There are certain circumstances where specific PPE is selected based on patient care or circumstances. 

Patient Safety 

During invasive procedures, such as inserting a central line or during a surgery, staff directly involved in performing the procedure or surgery must maintain sterility. Appropriate sterile PPE will be selected based on the type of procedure and the patient will be draped in a sterile fashion according to recommended guidelines (1). 

Patients in droplet precautions pose a significant risk to healthcare workers and visitors. The patient, as well as anyone inside the patient’s room, should wear a mask for the most effective prevention of transmission (1). 

Employee Safety 

Employees must ensure that they are evaluating the types of exposure that is likely to occur during patient care. Selection of PPE and appropriate barriers should consider the following: 

Barriers for contamination prevention: Per the CDC, “use of PPE is recommended based on the anticipated exposure to blood, body fluids, secretions, or excretions” (3). The following are CDC guidelines based on the expected type of exposure or precaution; however, clinical judgment should be used based on the situation (all from 5): 

• Standard precautions are to be used with any potential exposure to blood, mucous membranes, compromised skin, contaminated equipment or surfaces, and body fluids. Barriers may include gloves, gowns, and eye and face protection. 
• Employees must be judicious in identifying any precautions that are placed on a patient (i.e., Contact, droplet, airborne) and following recommended PPE guidelines for protecting themselves and other patients.  

• PPE should be donned prior to going into a patient room and doffed upon exit. PPE must never be worn in the halls or when going from one patient’s room to the next. All gloves must be changed in between use and hands washed or sanitized upon removal of gloves. 
• Additionally, whenever possible, social distancing of 6 feet should occur within the work environment. When not possible, adherence to mask guidelines is sufficient.  

Masks for prevention of exposure to communicable diseases: With the onset of COVID-19 across the globe, masks are an essential tool in preventing the transmission of communicable diseases. At a minimum, a medical mask is to be donned during all patient care. During procedures or surgery, surgical masks are to be utilized.  

N-95 masks are reserved for patient care with known or suspected Covid-19, if airborne precautions are ordered, or during procedures that may aerosolize (such as during intubations and certain endoscopy procedures).  

The CDC recommends reserving surgical N-95 masks for healthcare providers “who are working in a sterile field or who may be exposed to high-velocity splashes, sprays, or splatters of blood or body fluids”.  Standard N95 respirators are recommended for all other care involving confirmed or suspected Covid-19 patients (5). 

Guidance on Proper Utilization of PPE/Barriers 

Proper fit is required for PPE to be effective. Gowns and gloves chosen should fit well, allow movement, and neither be too baggy or too tight. For particulate respirators, the CDC recommends the following regarding proper fit and use of particulate respirators: 

All workers who are required to wear tight-fitting respirators (e.g., N95 respirators, elastomerics) must have a medical evaluation to determine the worker’s ability to wear a respirator, and if medically cleared, a respirator fit test needs to be performed using the same model available in the workplace (3, 4). 

Prior to donning PPE, it should be inspected for any anomalies, tears, or vulnerable spots. PPE that is compromised should be disposed of and a new garment selected. Nurses must consider the selection of PPE to ensure that it is the correct type for the job and anticipate any circumstances where splashes or saturation of fabric is likely to occur. 

The PPE provided by the employer may be single-use or reusable. Always verify with the manufacturer’s guidelines and facility policy on the correct usage and processing of worn garments. It is the facility’s responsibility to ensure that re-usable gowns are laundered according to State guidelines. 

In order to prevent cross-contamination, OSHA offers the following guidelines: 

• Personal protective equipment must be removed prior to leaving a work area 
• Garment penetrated by blood or other potentially infectious material must be removed immediately or as soon as possible 
• PPE must be discarded in “. . . an appropriately designated area or container for storage, washing, decontamination, or disposal” 
• Employers must ensure that proper hand washing is taking place after the removal of PPE 

Healthcare facilities have a legal duty to protect their workers. Per OSHA, “One way the employer can protect workers against exposure to bloodborne pathogens, such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), the virus that causes AIDS, is by providing and ensuring they use personal protective equipment or PPE. Wearing appropriate PPE can significantly reduce risk since it acts as a barrier against exposure. Employers are required to provide, clean, repair, and replace this equipment as needed, and at no cost to workers” (5). 

Employers and healthcare workers must understand the balance of cost versus benefit ratio in PPE selection and use. While it is important to be good stewards with resources, always erring on the side of caution and choosing PPE based on anticipated exposure risk is the most effective way to protect yourself and your patients. 

Selection, donning, doffing, and disposal. See Element II 

ELEMENT V 

Creation and maintenance of a safe environment for patient care in all healthcare settings through the application of infection control principles and practices for cleaning, disinfection, and sterilization. 

Definitions 

Contamination: The presence of microorganisms on an item or surface. 

Cleaning: The process of removing all foreign material (i.e., dirt, body fluids, lubricants) from objects by using water and detergents or soaps and washing or scrubbing the object 

Critical device: An item that enters sterile tissue or the vascular system (e.g., intravenous catheters, needles for injections). These must be sterile prior to contact with tissue. 

Decontamination: The use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles. 

Disinfection: The use of a chemical procedure that eliminates virtually all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial endospores) on inanimate objects. 

High-level disinfection: Disinfection that kills all organisms, except high levels of bacterial spores, and is affected with a chemical germicide cleared for marketing as a sterilant by the U.S. Food and Drug Administration (FDA). 

Intermediate level disinfection: Disinfection that kills mycobacteria, most viruses, and bacteria with a chemical germicide registered as a “tuberculocide” by the U.S. Environmental Protection Agency (EPA). 

Low-level disinfection: Disinfection that kills some viruses and bacteria with a chemical germicide registered as a hospital disinfectant by the EPA. 

Non-critical device: An item that contacts intact skin but not mucous membranes (e.g., blood pressure cuffs, oximeters). It requires low-level disinfection. 

Semi-critical device: An item that comes in contact with mucous membranes or non-intact skin and minimally requires high-level disinfection (e.g., oral thermometers, vaginal specula). 

Sterilization: The use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial endospores. 

Universal Principles 

Instruments, medical devices, and equipment should be managed and reprocessed according to the recommended and appropriate methods regardless of a patient’s diagnosis, except for cases of suspected prion disease. 

Due to the infective nature and steam-resistant properties of prion diseases, special procedures are required for handling brain, spinal, or nerve tissue from patients with known or suspected prion disease (e.g., Creutzfeldt-Jakob disease [CJD] or Bovine spongiform encephalopathy [BSE]). Consultation with infection control experts before performing procedures on such patients is warranted. 

Industry guidelines as well as equipment and chemical manufacturer recommendations should be used to develop and update reprocessing policies and procedures. Written instructions must be made available for each instrument, medical device, and equipment reprocessed.  

The CDC recommends that critical medical and surgical devices and instruments that would be expected to enter a system through which sterile body fluids, blood, or sterile tissue be sterilized prior to use on each patient. (1). 

Potential for Contamination  

The type of instrument, medical device, equipment, or environmental surface cause variables that are more likely to be a source of contamination. External contamination may be caused by the presence of hinges, crevices, or multiple interconnecting pieces.  

If able, these devices should be disassembled. Endoscopes provide a particular challenge for both internal and external contamination, due to their lumens as well as the crevices and joints present.  

The disinfectant must reach all surfaces and assurance that there are no air pockets or bubbles to impede penetration (2). As well, these devices may be made of material that is not heat resistant, which prevents the ability to sterilize. In these instances, chemicals must be utilized to provide disinfection. 

Once rendered sterile, there are multiple opportunities for potential contamination due to the frequency of hand contact with the device or surface. Packaging may be overhandled and breached, or the item may come into contact with potential contaminants via poor storage, improper opening, or environmental factors. 

The efficacy of sterilization and disinfection is dependent upon the number and type of microorganisms present. Several types of pathogens carry an innate resistance, making successful decontamination more challenging (2).  

Most infections are caused by bacteria, followed by viruses, fungi, protozoa, and prions (3).  Due to the nature of their outer membranes, spores, and gram-negative bacteria have a natural barrier that prevents the absorption of disinfectants.  

Bacterial spores are especially resistant to chemical germicides, as are the following pathogenic organism types (all from 2): 

• Coccidia – i.e. Cryptosporidium 
• Mycobacteria – i.e. M. tuberculosis 
• Nonlipid or small viruses – i.e. poliovirus, coxsackievirus 
• Fungi – i.e. Aspergillus, Candida 
• Vegetative bacteria – i.e. Staphylococcus, Pseudomonas 
• Lipid or medium-size viruses – i.e. herpes, HIV 

The number of microorganisms that are present on a medical instrument, device or surface affects the time that must be factored into disinfection and sterilization efficacy. As stated by the CDC, “Reducing the number of microorganisms that must be inactivated through meticulous cleaning, increases the margin of safety when the germicide is used according to the labeling and shortens the exposure time required to kill the entire microbial load” (2) 

In general, used medical devices are contaminated with a relatively low bioburden of organisms. Inconsistencies or incorrect methods of reprocessing can easily lead to the potential for cross-contamination (1). 

Steps of Reprocessing 

Reprocessing medical instruments and equipment is completed sequentially depending upon the instrument and the process chosen. 

Pre-cleaning is the process of removing soil, debris, and lubricants from internal and external surfaces through mopping, wiping, or soaking. It must be done as soon as possible after use to lower the number of microorganisms present on the object. 

Cleaning may be accomplished manually or mechanically. Manual cleaning relies upon friction and fluidics (fluids under pressure) to remove debris and soil from the inner and outer surfaces of the instrument. There are several different machines used in mechanical cleaning including ultrasonic cleaners, washer-disinfectors, washer-sterilizers, and washer-decontaminators. Studies have shown that automated cleaning is more effective than manual; however, the frequency of fluid changes must follow the manufacturer’s guidelines to eliminate the risk of contaminating debris (1). 

Disinfection involves the use of disinfectants, either alone or in combination, to reduce the microbial count to near insignificant. Common disinfectants used in the healthcare setting include chlorine and chlorine compounds, hydrogen peroxide, alcohols, iodophors, and quaternary ammonium compounds, among others. These products are formulated and then approved by the Environmental Protection Agency and Food and Drug Administration for specific uses. 

Sterilization is used on most medical and surgical devices that are utilized in healthcare facilities. This requires sufficient exposure time to heat, chemicals, or gases to ensure that all microorganisms are destroyed. 

Choice/Level of reprocessing sequence 

The choice or level of reprocessing is based on the intended use: 

• Critical instruments and medical devices require sterilization 
• Semi-critical instruments and medical devices minimally require high-level disinfection 
• Noncritical instruments and medical devices minimally require cleaning and low-level disinfection 

Manufacturer’s recommendations must always be consulted to ensure that appropriate methods, actions, and solutions are used. There is a wide variability of compatibility among equipment components, materials, and chemicals used. Rigorous training is required to appropriately understand the various equipment heat and pressure tolerance as well as the time and temperature requirements for reprocessing.  

Failure to follow the manufacturer’s recommendations may lead to equipment damage, elevated microbial counts on instruments after reprocessing, increased risk for infections, and possibly patient death. 

Effectiveness of reprocessing instruments, medical devices, and equipment 

Pre-cleaning and cleaning before disinfection is one of the most effective ways to reduce the microbial count. This is only effective when completed prior to disinfection.  

Disinfection relies upon the action of products to eliminate microbial count. Depending on the medical instrument or device design, the product may only be required to cover the surface. However, due to the lumens of scopes, crevices, or hinges on certain instruments, immersion products and dwell times are required (4). 

The presence of organic matter, such as blood, serum, exudate, lubricant, or fecal material can drastically reduce the efficacy of a disinfectant. This may occur due to the presence of organic material acting as a barrier.  It may also occur from a chemical reaction between the organic material and the disinfectant being utilized. 

Biofilms pose a particular challenge and offer protection from the action of disinfectants. Biofilms are composed of microbes that build adhesive layers onto the inner and outer surfaces of objects, including instruments and medical devices, rendering certain disinfectants ineffective. Chlorine and Monochloramines remain effective against inactivating biofilm bacteria (1). 

Per the CDC, “. . . a given product is designed for a specific purpose and is to be used in a certain manner. Therefore, users should read labels carefully to ensure the correct product is selected for the intended use and applied efficiently” (1). The label will indicate sufficient contact time with the chemical solution to achieve adequate disinfection. 

After disinfection, staff and management must adopt a system of record keeping and tracking of instrument usage and reprocessing. Reprocessing equipment must be on a schedule to be maintained and regularly cleaned, according to the manufacturer’s guidelines. 

There are several methods of sterilization used such as steam sterilization (autoclaves), flash sterilization, and more recently, low-temperature sterilization techniques created for medical devices that are heat sensitive. Selection depends upon the type of instrument, material, ability to withstand heat or humidity, and targeted microbes. 

There are several methods of ensuring that sterilized instruments are processed and tracked appropriately. Indicators or monitors are test systems that provide a way of verifying that the sterilization methods were sufficient to eradicate the regulated number of microbes during the process. These safeguards include: 

• Biologic monitors 
• Process monitors (tape, indicator strips, etc.) 
• Physical monitors (pressure, temperature gauges) 
• Record keeping and recall/ tracking system for each sterilization processing batch/item 

Studies have shown that the best practice of handling and storage of reprocessed medical equipment and instruments uses a system of event-related shelf life, rather than time-related. The rationale for this lies in the theory that the sterile items remain sterile as long as the packaging is not compromised (2).  

Factors that are considered event-related include internal or external contamination such as damage to the packaging, humidity, insects, vermin, open shelving, temperature fluctuations, flooding, location, and the composition of packaging material. 

Standards for handling must also focus on the protection of workers from health issues. 

Recognizing Potential Sources of Cross-Contamination in The Healthcare Environment  

1. Surfaces or equipment which require cleaning between patient procedures/treatments 
2. Practices that contribute to hand contamination and the potential for cross-contamination 
3. Consequences of reuse of single-use/disposable instruments, medical devices, or equipment 

Factors That Have Contributed to Contamination in Reported Disease Transmission Cases 

At any point in reprocessing or handling, breaks in infection control practices can compromise the integrity of instruments, medical devices, or equipment. Specific factors include: 

• Failure to reprocess or dispose of items between patients 
• Inadequate cleaning 
• Inadequate disinfection or sterilization 
• Contamination of disinfectant or rinse solutions 
• Improper packaging, storage, and handling 
• Inadequate/inaccurate record keeping of reprocessing requirements. 

Expectations Regarding Differing Levels of Disinfection and Sterilization Methods 

Professionals who practice in settings where handling, cleaning, and reprocessing equipment, instruments, or medical devices is performed elsewhere (e.g., in a dedicated Sterile Processing Department) are responsible for ensuring understanding of the core concepts and principles: 

• Standard and Universal Precautions (e.g., wearing of personal protective equipment) 
• Cleaning, disinfection, and sterilization (Sections III and IV above) 
• Appropriate application of safe practices for handling instruments, medical devices, and equipment in the area of professional practice 
• Designation and physical separation of patient care areas from cleaning and reprocessing areas is strongly recommended by NYSDOH. 
• Verify with those responsible for reprocessing what steps are necessary prior to submission of pre-cleaning and soaking 

Professionals who have primary or supervisory responsibilities for equipment, instruments, or medical device reprocessing (e.g., Sterile Processing Department staff or clinics and physician practices where medical equipment is reprocessed on-site) are responsible for understanding core concepts and principles: 

• Standard and Universal Precaution 
• Cleaning, disinfection, and sterilization described in Sections III and IV above 
• Appropriate application of safe practices for handling instruments, medical devices, and equipment in the area of professional practice 
• Designation and physical separation of patient care areas from cleaning and reprocessing areas is strongly recommended by NYSDOH 

Facilities must be fastidious in developing appropriate reprocessing practices that follow regulatory guidelines. When selecting appropriate methods, consideration must be given to the antimicrobial efficacy, time constraints, and requirements of these methods, as well as compatibility. Compatibility among equipment/materials includes corrosiveness, penetrability, leaching, disintegration, heat tolerance, and moisture sensitivity. 

The toxicity of the products used can pose occupational and environmental hazards to staff and patients. Facilities must adopt procedures and policies to reduce exposure to harmful substances, monitor for harmful exposures, and train staff using reprocessing cleaning and chemicals.  

To reduce potential exposure to harmful substances, OSHA mandates that training for workers before use include (all from 5): 

• Health and physical hazards of the cleaning chemicals 
• Proper handling, use, and storage of all cleaning chemicals being used, including dilution procedures when a cleaning product must be diluted before use 
• Proper procedures to follow when a spill occurs 
• Personal protective equipment required for using the cleaning product, such as gloves, safety goggles and respirators 
• How to obtain and use hazard information, including an explanation of labels and SDSs 

Other considerations in developing a safety plan for appropriate reprocessing practices include: 

• Potential for patient toxicity/allergy 
• Residual effects including antibacterial residual and patient toxicity/allergy 
• Ease of use 
• Stability of products, including concentration, potency, efficacy of use, and effects of organic material 
• Odor 
• Cost 
• Monitoring requirements and regulations 
• Specific labeling requirements for reprocessing single-use devices 

ELEMENT VI 

Prevention and control of infectious and communicable diseases in healthcare workers. 

Definitions 

Infectious Disease: A clinically manifest disease of humans or animals resulting from an infection. 

Communicable Disease: An illness due to a specific infectious agent or its toxic products that arises through transmission of that agent from an infected person, animal, or inanimate source to a susceptible host. 

Occupational Health Strategies: As applied to infection control, a set of activities intended to assess, prevent, and control infections and communicable diseases in healthcare workers. 

Pre-Placement and Periodic Health Assessments  

Occupational health strategies are aimed at ensuring employees are healthy and keeping them healthy. Upon hiring, employees should undergo an initial health screening that reviews immunization records.  

The CDC suggests that healthcare workers are screened when newly hired and periodically ongoing to (all from 1): 

• Ensure sufficient immunity to vaccine-preventable diseases such as measles, mumps, rubella, varicella, hepatitis B, annual influenza and any other recommended or mandated requirements 
• Assess for and manage underlying conditions and illnesses that may affect workplace safety 
• Prevent, assess, and treat any potential infectious exposures or illnesses that may be acquired or transmitted within the healthcare setting 
• Initiate and continue personalized health counseling 
• Thorough history and physical 

A tuberculosis screening should be completed before a new employee provides patient care and upon possible exposure for an existing employee. A thorough assessment should include an evaluation of the following symptoms: 

• Fever 
• Cough 
• Chest pain, or pain with breathing or coughing 
• Night sweats 
• Chills 

A Mantoux tuberculin skin test (TST) must also be completed. The test is performed by injecting a small amount of tuberculin into the epidermis of the forearm. The test is then evaluated for a reaction in 48 to 72 hours.  

If there is no reaction, the test result is negative. If reactive, a scale is used to interpret the measurement of induration and to direct further testing or treatment (2). 

When working in healthcare, nursing staff must be healthy to provide optimal care. This is especially true in the care of vulnerable patients who have weakened immune symptoms.  

The following symptoms require immediate evaluation by a licensed medical professional: 

• Fever 
• Cough 
• Rash 
• Vesicular lesions 
• Draining wounds 
• Vomiting 
• Diarrhea 

Upon evaluation, there may be possible restrictions from patient care activities and work clearance must be completed prior to return. 

Management Strategies for Potentially Communicable Conditions  

Management and the Infection Prevention department should collaborate and strategize to ensure that employees who have had an exposure or possible exposure are protected and have support in seeking treatment without fear of retaliation or job loss (3). Managerial support should prioritize: 

• Appropriate evaluation and treatment 
• Limiting contact with susceptible patients and staff  
• Placement in a non-clinical setting 
• Depending on the severity of symptoms or potential transmission, a furlough until no symptoms are present may be necessary 

Prevention and Control Strategies for Bloodborne Pathogen Transmission 

Robust training and educational programs are essential for the prevention of healthcare worker exposure and transmission. Prevention strategies should include education, training, and availability of the following: 

• Information on potential agents such as HBV, HCV, and HIV 
• HBV vaccination (including safety, efficacy, components, and recommendations for use) 
• Hand hygiene 
• Appropriate PPE and barrier precautions (see Element II) 
• Sharps safety (see Element III) 
• Standard and Universal Precautions 
• Education on the availability of confidential and anonymous testing for bloodborne pathogens (4) 

Post-Exposure Evaluation and Management.  

Each facility must plan for post-exposure evaluation and management in the case that any employee or patient experiences a potential or actual bloodborne exposure. The plan should incorporate the following: 

• Prompt evaluation by a licensed medical professional 
• Risk assessment in occupational exposures 
• Recommendations for approaching source patient and healthcare worker evaluations 
• Recommendations for post-exposure prophylaxis emphasizing the most current NYSDOH and CDC guidelines 
• Post-exposure management of patients or other healthcare workers when the exposure source is a healthcare worker obligates the patient to be informed of the type of exposure, whether it is the healthcare worker’s blood or other potentially infectious material. 

Airborne or droplet pathogens require several special considerations. The above guidelines should be applied appropriately. As well, New York requires mandatory reporting of certain communicable diseases is required, including tuberculosis. The New York State Department of Health (NYSDOH) states: 

Reporting of suspected or confirmed communicable diseases is mandated under the New York State Sanitary Code (10NYCRR 2.10,2.14). The primary responsibility for reporting rests with the physician; moreover, laboratories (PHL 2102), school nurses (10NYCRR 2.12), daycare center directors, nursing homes/hospitals (10NYCRR 405.3d), and state institutions (10NYCRR 2.10a) or other locations providing health services (10NYCRR 2.12) are also required to report (5). 

NYSDOH follows the CDC’s recommended guidelines when exposure to TB occurs. The HCW should be retested for TB using TST and be monitored for symptoms of disease progression. If found to have a TST reaction of 10 or more millimeters, the patient would be given high priority to receive drug treatment under the criteria of working within a high-risk setting (6). Drug treatment typically consists of 3 months of isoniazid once weekly in addition to rifapentine in adults and children over 2 years old. 

Post-exposure of other Airborne pathogens such as varicella, measles, mumps, rubella, and pertussis should be directed toward the most current federal, state, or local requirement for post-exposure evaluation and management. As with tuberculosis, mandatory reporting may be required. The Communicable Disease Reporting Requirements form may be found here. 

For additional, up-to-date information and guidance, the New York State Department of Health Bureau of Communicable Disease Control can be reached at (518) 473-4439 or (866) 881-2809 after hours. 

All patients and health care workers who have been potentially exposed to any pathogens should be educated and counseled about (all from 7): 

• Risk of exposure or illness 
• Testing 
• Options for and risks and benefits of post-exposure prophylaxis or treatment 
• Need for specialty care 
• Follow-up testing and treatment 
• Work restrictions, if indicated 
• Risk of transmitting infections to others and methods to prevent transmission, and 
• Signs and symptoms of illness to report after exposure, including side effects such as prophylaxis. 

Evaluation of Healthcare Workers Infected with Bloodborne Pathogens 

The NYSDOH provides the following rules and recommendations based on scientific evidence-based practice in relation to policies to prevent infected healthcare personnel-related blood-borne pathogen transmission (HIV, HBV, HCV) (all from 4): 

• Strict adherence to Standard Precautions 
• Voluntary testing without fear of disclosure or discrimination 
• Mandatory screening of New York HCW for blood-borne pathogens is not recommended. Such a program would cost millions of dollars and would not produce any appreciable gain in public safety. Negative antibody tests for HIV, HBV, and HCV do not rule out the presence of infection since it can take some time for measurable antibodies to appear. 
• Employer notification of a blood-borne pathogen is not a requirement for employment 

Criteria must be followed when evaluating infected healthcare workers for the risk of transmission in order to adhere to laws protecting workers from discrimination and disability laws. The following outlines a general assessment to determine the risks posed: 

1. Nature and scope of professional practice 
2. Techniques used in the performance of procedures that may pose a transmission risk to patients 
3. Assessed compliance with infection control standards 
4. Presence of weeping dermatitis, draining, or open skin wounds 
5. Ability to carry out duties with Cognitive status examination 

Expert Panels for Evaluating Healthcare Workers Infected with Bloodborne Pathogens 

Upon request, a blood-borne pathogen-infected HCW may seek advice from the NYSDOH regarding potential risk during patient care of blood-borne disease transmission. A state advisory panel would convene with, at minimum, representation by a state or local public officer, an epidemiologist, and an infectious disease expert (4).  

The purpose of the panel is to provide consultation to the MCW regarding the risk of blood-borne disease transmission related to occupation and to give recommendations on best practices, needs for limitations, modifications, or restrictions if there is an identified risk to patient care. Confidentiality is maintained with the restriction that recommendations are followed, and any restrictions are disclosed to the facilities where the HCW is currently employed or seeks future employment (4)

ELEMENT VII 

Sepsis awareness and education 

Definitions 

Sepsis: Sepsis is a life-threatening condition caused by a host’s extreme response to infection. The Surviving Sepsis Campaign 2016 International Guidelines define sepsis as life-threatening organ dysfunction caused by a dysregulated host response to infection. Earlier definitions defined sepsis as an inflammatory response to infection, while sepsis associated with organ dysfunction was identified as severe sepsis. Septic shock is a subset of sepsis that manifests with circulatory and cellular/metabolic dysfunction; it is associated with a higher mortality risk. 

Scope of the Problem 

Over 1.7 million Americans are diagnosed with sepsis each year, with the incidence rising by approximately 8% annually. In New York, there are approximately 50,000 patients treated for severe sepsis and septic shock, resulting in just under 30% of patients dying each year (1).  

Sepsis is a life-threatening medical emergency that requires early recognition and intervention. Sepsis occurs when the body overcompensates in response to an infection, resulting in multiple organ dysfunction and damage.  

Most sepsis cases are community-acquired. Seven in 10 patients with sepsis had recently used healthcare services or had chronic conditions requiring frequent medical care (1).  Early recognition and treatment are the most effective ways to combat sepsis. 

In 2013, New York State became the first in the U.S. to develop a state mandate that requires all hospitals to develop and adopt sepsis protocols. The mandate is dubbed “Rory’s Regulations,” after Rory Staunton, a 12-year-old boy whose death was attributed to lack of sepsis recognition. These protocols were required to adopt the following practices (2): 

• A process for the screening and early recognition of patients with sepsis, severe sepsis, and septic shock. 
• A process to identify and document individuals appropriate for treatment through severe sepsis protocols, including explicit criteria defining those patients who should be excluded from the protocols, such as patients with certain clinical conditions or who have elected palliative care. 
• Guidelines for hemodynamic support with explicit physiologic and biomarker treatment goals, methodology for invasive or non-invasive hemodynamic monitoring, and time frame goals. 
• For infants and children, guidelines for fluid resuscitation with explicit time frames for vascular access and fluid delivery are consistent with current evidence-based guidelines for severe sepsis and septic shock with defined therapeutic goals for children. 
• A procedure for identification of infection source and delivery of early antibiotics with time frame goals; and 
• Criteria for use, where appropriate, of an invasive protocol and for use of vasoactive agents. 
• Medical staff also gained responsibility for the collection, use, and report quality measures and for the mortality data of peers, including national, hospital, and expert stakeholders (2). 

This led to The New York State Sepsis Care Improvement Initiative, started in 2014, to increase early recognition of suspected sepsis and competence in implementing the new sepsis protocols by all healthcare professionals.  

This was to be achieved through mandatory training or coursework on sepsis (3). The goal was to stress the importance of timely initiation of evidence-based protocols to improve sepsis outcomes. 

Causes of Sepsis  

As stated by the Sepsis Alliance, “Sepsis is the body’s overwhelming and life-threatening response to infection that can lead to tissue damage, organ failure, and death” (4).  

Bacterial infections commonly trigger sepsis, although other microbial infections (e.g., fungal or viral) can also trigger sepsis. The triggering infection most commonly originates from the lungs, urinary tract, skin, and/or gastrointestinal tract. 

Certain populations are at an increased risk of developing sepsis including: 

• Babies (under 1 year), and individuals 65 years of age and older. 
• People with chronic conditions such as diabetes, lung disease, kidney disease, or cancer; and 
• People with impaired immune systems. 

Early Recognition of Sepsis  

• Manifestations of sepsis vary based on the type of infection and host factors. 
• Some people may have subtle sepsis presentations. 
• Signs and symptoms that may be associated with sepsis in persons with confirmed or suspected infection can include: 
• Altered mental state 
• shortness of breath 
• fever 
• clammy or sweaty skin 
• extreme pain or discomfort 
• high heart rate 

Signs and symptoms in children and the elderly may not present the same. In children and the elderly sepsis symptoms may present as above or any of the following: decreased temperature; pallor or bluish tone to skin; non-blanching rash; high respiratory rate; lethargy; and seizure. 

Sepsis can progress to more severe forms of sepsis, including septic shock. When septic shock occurs, the body’s inflammatory response causes extensive vasodilation throughout the body. This results in a sudden drop in blood pressure that can quickly lead to organ failure and damage (5). 

If a person presents with suspected or confirmed infection, healthcare professionals should assess for signs of, and risk factors for sepsis following facility sepsis protocols. 

Principles of Sepsis Treatment  

Sepsis treatment starts with prompt recognition and diagnosis. The diagnosis of sepsis starts with the assessment of a patient with a known or suspected infection. For adults, sepsis is defined as having two or more symptoms of systemic inflammatory response syndrome, which includes (6): 

• Temperature (>38 o C or <36 o C) 
• Elevated heart rate > 90 bpm 
• WBC (<4×109/L or >12×109/L) 
• Respiratory rate (>20 breaths/min, PACO2<32 mm Hg 

Severe sepsis has traditionally been defined as having sepsis plus organ failure, while septic shock involves sepsis along with refractory hypotension after fluid resuscitation or requiring vasopressors to maintain hemodynamics (6). The standard changed in 2016 with the elimination of severe sepsis; however, most facilities still adhere to the above criteria. Follow sepsis protocol and bundles per facility. 

With the recognition of sepsis and/or septic shock, previously state law mandated that one- and three-hour care bundles be created. While these may vary slightly per facility, Surviving Sepsis promotes a one-hour bundle that incorporates all the recommendations of the other bundles yet decreases the time to treat (7): 

One Hour Bundle 

1. Obtain lactate level. Reorder if initial lactate is > 2 mmol/L 
2. Obtain blood cultures before administering antibiotics 
3. Administer broad-spectrum antibiotics 
4. Rapidly infuse crystalloids at a rate of 30 mL/kg for hypotension or lactate ≥ 4 mmol/L 
5. If hypotensive post fluid resuscitation, administer vasopressors to maintain a mean arterial pressure ≥ 65 mm Hg. 

In addition to blood cultures, type and screens may be ordered for urine, wound exudate, or respiratory secretions depending upon where the suspected infection originates from. Blood tests may also include a complete blood count and a basic metabolic panel to assess for any damage to the kidneys or liver. Other diagnostic imaging may include chest X-rays, CTs, ultrasounds, and MRIs (8). 

Fluid resuscitation and vasopressors, if needed, will continue until the patient is hemodynamically stable. Physicians should be notified when blood cultures result in order to ensure that the ordered antibiotic is effective against the identified organism (8). 

Patient Education and Prevention  

Patient education should strive to provide memorable and simple ways to stay free of infection. The number one method of preventing infection is adequate hand hygiene. The CDC also suggests that patients keep wounds and cuts clean and covered until healed. 

Patients at higher risk should be notified of their risk factors, including (9): 

• Adults 65 or older 
• People with chronic medical conditions, such as diabetes, lung disease, cancer, and kidney disease 
• People with weakened immune systems 
• Sepsis survivors 
• Children younger than one 

Patients should be educated on warning signs and symptoms of sepsis that are easy to remember. The Sepsis Alliance suggests the following acronym and verbiage for seeking immediate care (4): 

Patients should be encouraged to give relevant history and information to clinicians, including if they have had a recent infection, sepsis in the past, or are immunocompromised. 

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