Created by Jennifer Majeske, Mineral Area College

Created by Jennifer Majeske, Mineral Area College
Infection Control Chapter 10 Created by Jennifer Majeske, Mineral Area College

Learning Objectives Explain the role of pathogenic organisms in causing disease. Distinguish among bacteria, viruses, fungi, and protozoa. Discuss the advantages and disadvantages of various forms of sterilization. Identify common modes of contamination and preventive measures that can be taken to reduce or eliminate these risks. Discuss the guidelines set forth by the Centers for Disease Control and Prevention that address preventing the transmission of infectious agents in the hospital. Created by Jennifer Majeske, Mineral Area College

Learning Objectives Understand the distinction between hand-washing and hand-hygiene practices and the importance of these practices in infection control. Discuss the importance of vaccinations for healthcare workers. Discuss the USP Chapter <797> guidelines for sterile compounding and aseptic technique. Identify procedures to minimize airborne contamination during the compounding of sterile preparations. Created by Jennifer Majeske, Mineral Area College

Learning Objectives Contrast a manufactured sterile product with expiration dating vs. a compounded sterile preparation with beyond-use dating according to USP Chapter <797> guidelines. Apply contamination risk level designations and appropriate beyond-use dating for compounded sterile preparations. Identify the role of the Infection Control Committee within a hospital. List Universal Precautions that protect hospital employees. Created by Jennifer Majeske, Mineral Area College

Introduction Compounded sterile preparations (CSPs), or medications that are created by mixing one or more sterile products using aseptic technique. Microbiology – the study of microorganisms. General understanding of the germ theory of disease; various sources of contamination; and the process of sterilization and aseptic technique, is important by pharmacy personnel. Awareness of infection control procedures is critical during sterile compounding. Created by Jennifer Majeske, Mineral Area College

The Development of the Germ Theory of Disease
The cause of illnesses – until most recently – were not completely understood. What were diseases attributed to? Seventeenth-Century Scientists: Anton van Leeuwenhoek made the first crude microscope; 1673, confirmed the existence of a microculture of organisms. Microorganisms – “animalcules” (little animals). Robert Hooke, observed the walls of dead plant cells. Spontaneous generation – the belief that some forms of life could arise spontaneously from matter. Francesco Redi, maggots could not spontaneously arise. Created by Jennifer Majeske, Mineral Area College

Important Discoveries of Jenner and Pasteur
1798 Edward Jenner discovered the principle of immunization against disease. Louis Pasteur was instrumental is proving the connection between microorganisms and disease by demonstrating that the fermentation process is caused by the growth of microorganisms. Pasteurization – a process to kill most bacteria and mold in milk. Germ theory of disease – the idea that microorganisms cause diseases. Created by Jennifer Majeske, Mineral Area College

Medical Advances of Lister and Koch
Joseph Lister “Father of Modern Antisepsis”, began soaking dressings in carbolic acid, to kill bacteria. Lister later developed antiseptic methods in surgery, these are the basis of sterile technique; these techniques reduced postoperative infections and saved lives. 1876, German physician Robert Koch defined a series of steps known as Koch’s postulates. These postulates could be used to prove that a certain disease was caused by a specific microorganism. Created by Jennifer Majeske, Mineral Area College

Bacteria Bacterium: a small, single-celled microorganism. Bacteria exist in three main forms: Spherical (cocci) Rod shaped (bacilli) spirochettes Gram positive (blue or purple) Gram negative (red) Bacteria cause a variety of illnesses: Food poisoning, strep throat, ear infections, rheumatic fever, meningitis, pneumonia, tuberculosis, and conjunctivitis Created by Jennifer Majeske, Mineral Area College

Viruses Virus: a small microorganism that consists of little more than a bit of genetic material enclosed by a casing of protein. Viruses need a living host in order to reproduce. Viruses cause a variety of diseases: Colds, mumps, measles, chickenpox, influenza, hepatitis, and HIV Created by Jennifer Majeske, Mineral Area College

Fungi Fungus: a parasite on living organisms (by feeding on dead organic material) that reproduces by means of spores. Spores and some fungi are microscopic plants that can occur as mold, mildew, or mushrooms; they can also travel through the air. Penicillin is the result of a mold source. Fungal infections include: Athlete’s foot, ringworm, vaginal yeast infections, and serious systemic fungal infections Created by Jennifer Majeske, Mineral Area College Cryptococcosis

Protozoa Protozoan – a microscopic organism made up of a single cell or a group of more or less identical cells. Protozoa live in water or as parasites inside other creatures. Examples of protozoa: Paramecia Amoebas Illnesses caused by protozoa: Amoebic dysentery Malaria Sleeping sickness: Created by Jennifer Majeske, Mineral Area College

Functions of Microorganisms
Microorganisms can be harmless or beneficial (nonpathogenic) or harmful (pathogenic). Nonpathogenic Microorganisms: Some microorganisms perform essential functions. Yogurt Pathogenic Microorganisms: lead to widespread illness and disease. Created by Jennifer Majeske, Mineral Area College

Functions of Microorganisms
Epidemics and Pandemics: Epidemic – increased incidence of a particular disease in a given area or among a certain group of people over a specific period. Pandemic – affects a sizable population of several countries (epidemic of world-wide proportions). See pg. 404 for notable pandemics Current Antimicrobial Medications: Antibiotics, antivirals, and antifungals Microorganisms can adapt and become resistant Resistance is caused by over prescribing or incorrect administration. Created by Jennifer Majeske, Mineral Area College

Sources of Contamination
Transmission of microbes can occur by touch, air, and water. Touch: the most common method of contamination and the easiest to prevent. Air: microorganisms are found in the air, dust particles and moisture droplets. Water: even tap water is not completely free of microorganisms; moisture droplets after a sneeze or a cough often contain harmful microbes. Created by Jennifer Majeske, Mineral Area College

Asepsis and Sterility Establishment of sterile practices in the 19th century. Asepsis – the absence of pathogenic microorganisms. Sterility – the absence of all microorganisms, brought about by sterilization – a process that destroys the microorganisms. Methods of Sterilization: Heat Dry heat Mechanical Gas Chemical Created by Jennifer Majeske, Mineral Area College

Heat Sterilization Heat is available, effective, economical and easily controlled. Boiling kills vegetative forms, viruses, and fungi in about 10 minutes; more time is required to kill other organisms like, fungus spores and hepatitis virus. Autoclave - a device that generates heat and pressure to sterilize. Heat sterilization is being used less because of space requirements, equipment expense, and personnel training. Created by Jennifer Majeske, Mineral Area College

Dry Heat Sterilization
Dry heat, like direct flaming, destroys all microorganisms. It is used for the disposal of contaminated objects, incineration. Proper sterilization using hot, dry air must be at a temperature of 170°C and maintained for approximately 2 hours. Why do you think a higher temperature is required for dry heat? Created by Jennifer Majeske, Mineral Area College

Mechanical Sterilization
Filtration is the means by which mechanical sterilization is achieved; the passage of a liquid or gas through a screen-like material with pores small enough to block microorganisms. This is used for the sterilization of heat-sensitive materials like: culture media, enzymes, vaccines, and antibiotic solutions. 0.22 micron filters are used for bacteria; 0.01 micron filters are used for viruses and some large proteins Phlebitis – inflammation of the veins is reduced by the use of inline filters in IV administration sets. Created by Jennifer Majeske, Mineral Area College

Gas Sterilization Gas sterilization, ethylene oxide, is used for objects that are labile, or subject, to destruction by heat. Special equipment and aeration of materials is required after application of the gas. The gas used is highly flammable and is used only in large institutions. Some prepackaged IV fluids and bandages are manufactured and sterilized in this manner. Ethylene oxide leaves only a slight, non-harmful residue, which is detectable as an odor. Created by Jennifer Majeske, Mineral Area College

Chemical Sterilization
Chemical sterilization involves the destruction of microorganisms on inanimate objects by chemical means. Chemicals rarely produce complete sterility, but can reduce microbial numbers to safe levels. Disinfectant: a chemical applied to an object or topically to the body for sterilization purposes. Topical disinfectants include: iodine, isopropyl alcohol (IPA) and bleach. Created by Jennifer Majeske, Mineral Area College

Organizations Overseeing Infection Control
Understanding disease transmission and asepsis practices is necessary to infection control. At the national level, the Centers for Disease Control and Prevention (CDC) and the United States Pharmacopeia (USP) set guidelines that must be followed by hospitals and healthcare workers. At the local level, a hospital’s infection control committee develops hospital specific policies and procedures. Created by Jennifer Majeske, Mineral Area College

The Centers for Disease Control and Prevention
Centers for Disease Control and Prevention (CDC) - is a government agency the provides guidelines and recommendations on infection control. The CDC publishes reports on the sensitivity and resistance of various bacteria, guidelines of drug choice, dosage, and duration of treatment for common infectious illnesses. The CDC’s major focus is on the prevention of transmission of infectious agents in the hospital. The CDC updates and publishes guidelines to protect the patient and the healthcare worker from infectious disease. Created by Jennifer Majeske, Mineral Area College

The Centers for Disease Control and Prevention
The guidelines are known as Universal Precautions. The CDC estimates that hospital patients acquire 1.7 million infectious disease during their hospital stays. Failure to train hospital employees or healthcare personnel to follow proper infection control could produce a high incidence of HAIs (Healthcare-Associated Infections), or nosocomial infections. Some of the infection control procedures outlined include: hand hygiene, protective clothing, and vaccinations of personnel. Created by Jennifer Majeske, Mineral Area College

Hand Washing Simple hand washing and hand hygiene, according to the CDC, are the single most important practices for minimizing touch contamination and reducing the transmission of infectious agents. Hand washing – using plain or antiseptic soap and water. Plain detergent soaps with minimal anti-microbial activity must be used for 20 to 30 seconds. Adherence to proper hand-washing technique in the hospital remains less than 50%, according to the CDC. Created by Jennifer Majeske, Mineral Area College

Hand Hygiene Hand hygiene - using special alcohol-based rinses, gels, or foams that do not require water. Alcohol based products are preferred because of their superior antimicrobial activity, shorter contact time, quick drying effect, minimal skin irritation, and convenience. Table 10.1 Hand Washing and Hand Hygiene Guidelines Created by Jennifer Majeske, Mineral Area College

Personal Protective Equipment (PPE)
PPE is critical to infection control in a facility, protecting both healthcare workers and others from infectious diseases. Gown or Apron: worn over the required uniform or scrubs with the opening in the back; ties should be secure. Masks and Respirators: placed over the nose, mouth, and chin and secured to the back of the head using ties or elastic. Goggles and Face Shields: positioned over the eyes or face and secured to the head with earpieces or elastic. Created by Jennifer Majeske, Mineral Area College

Gloves The CDC recommends that healthcare workers use gloves, primarily to prevent the transmission of normal or pathogenic skin flora to patients. Aseptic hand washing alone may not prevent the transmission of microorganisms if hands are heavily contaminated. Gloves are made of latex or vinyl; both materials appear to offer comparable protection. Latex-free gloves should be available to those sensitive to latex. Used gloves should be discarded in a designated area. Gloves should never be washed or reused. Created by Jennifer Majeske, Mineral Area College

Vaccination More than 35,000 people die each year as a result of flu complications; 200,000 are hospitalized. The CDC recommends if you are working in a hospital setting that you receive an annual flu shot. Benefits of the Flu Vaccine: What are some of the benefits associated with getting the flu vaccine? Administration of the Flu Vaccine: 63% of healthcare workers get an annual flu shot; 60 to 70% effective. Administration of the Nasal Flu Vaccine: attenuated virus – live, present in the nasal flu vaccine. Created by Jennifer Majeske, Mineral Area College

USP Chapter 797 Standards The United States Pharmacopeia (USP) publishes guidelines on the preparation of sterile products with properly trained personnel and protective equipment. 2004, the USP developed the first official and enforceable requirements for sterile preparation compounding. Guidelines were modified and updated in 2007 and approved in 2008. USP Chapter <797> - focuses on sterility and stability of a compounded sterile preparation. Created by Jennifer Majeske, Mineral Area College

USP Chapter 797 Standards Compounded sterile preparation (CSP) - a sterile product that is prepared outside of the pharmaceutical manufacturer’s facility. Sterility refers to the CSP being free of microorganisms. Stability - refers to chemical and physical characteristics, such as pH, degradation, formation of precipitates, or unexpected color changes. Created by Jennifer Majeske, Mineral Area College

USP Chapter 797 Standards Requirements for sterile compounds differ from nonsterile compounds: Working in a defined clean-room environment Additional requirements for personnel garbing Personnel testing and training Environmental quality specifications Disinfection of gloves and surfaces Created by Jennifer Majeske, Mineral Area College

USP Chapter 797 Standards 797 standards apply to all personnel involved in the preparation, storage and transportation of CSP’s. CSP’s include: drugs, biologicals, diagnostics, nutrients, and radioactive pharmaceuticals 797 standards also apply to all practice settings: Compounding Nuclear Home health Long-term healthcare pharmacy Clinics and physician’s offices Created by Jennifer Majeske, Mineral Area College

Sterile Compounding Facility
Compounding facilities are designed to minimize airborne contamination. High-efficiency particulate airflow (HEPA) filter – minimizes airborne contamination. International Organization for Standardization (ISO) - define the amount of particulate matter allowed in room air where CSPs are prepared. The lower the ISO number, the less particulate matter is present in the air. Created by Jennifer Majeske, Mineral Area College

Sterile Compounding Areas
Figure 10.2 pg. 413 Sterile Compounding IV Room Layout, is divided into two main areas: the anteroom and the clean room. Personnel are responsible for maintaining the overall cleanliness of these areas. Anteroom – where personnel perform aseptic hand washing and garbing procedures, gather supplies and check expiration dates, etc.; ISO Class 8. Clean room – IV room or buffer area, the inner most room within the pharmacy; houses the laminar airflow hoods; ISO Class 7. Created by Jennifer Majeske, Mineral Area College

Compounding Equipment and Supplies
Only furniture, equipment and supplies necessary for the preparation of CSPs should be allowed in defined compounding areas; long-term storage is not permitted. Laminar Airflow Hoods: HEPA-filtered air to create an ISO Class 5 environment in the direct compounding area (DCA) of the hood. Horizontal LAFW (positive-pressure) Vertical LAFW (negative-pressure) Created by Jennifer Majeske, Mineral Area College

Horizontal LAFW Air flows from the back of the hood, across the work surface, and out into the room. As air passes through the hood it is prefiltered by a high-efficiency particulate air (HEPA) filter. The HEPA filter removes 99.97% of all particles 0.5 micron or larger. When working in the hood it is necessary to work at least 6 inches inside the hood. Created by Jennifer Majeske, Mineral Area College

Horizontal LAFW Placement of supplies should not impede the sterile airflow that moves across the work surface and around and over supplies. Created by Jennifer Majeske, Mineral Area College

Vertical LAFW Vertical laminar airflow workbench (LAFW) is used for the preparation of hazardous CSPs. Air flows from the top of the hood down, through a pre-filter and a HEPA filter onto the work area. The air is then recirculated through another HEPA filter, and vented 100% to outside air minimize human exposure. When working in and cleaning a vertical LAFW a technician should wear: Eye protection, a mask, and proper apparel – gown, gloves, and hair covering Created by Jennifer Majeske, Mineral Area College

Cleaning the Horizontal LAFW
Horizontal and vertical laminar airflow hoods are regularly cleaned according to USP Chapter <797> guidelines. The hood must be cleaned at the beginning of each shift, before each batch compounding session, and every 30 minutes during continuous sterile compounding. The hood should run for at least 30 minutes after being turned off, before being used to prepare CSPs. The entire LAFW should be cleaned first with sterile water and then with 70% isopropyl alcohol. During cleaning the blower should remain on, and the technician should be in full protective garb. Created by Jennifer Majeske, Mineral Area College

Start with the hood’s hang bar and hooks; hood’s ceiling – overlapping, side-to-side strokes; both sides of the hood – overlapping, down-and-up strokes, from the innermost part of the hood to the exterior ; and the work surface. Created by Jennifer Majeske, Mineral Area College

Cleaning the Vertical LAFW
Clean the entire hood with sterile water, then by 70% isopropyl alcohol; the vertical hood must be allowed to run continuously during cleaning and decontamination. Biological safety cabinet (BSC) is one of the most commonly used vertical hoods. The HEPA-filter is located in the ceiling of the hood rather than the back, with the air flow downward toward the hood’s work surface, changing the cleaning order as well as direction of cleaning strokes. Prefilter and HEPA Filter Maintenance: the prefilter must be replaced every 30 days; the HEPA filter must be recertified every 6 months. Created by Jennifer Majeske, Mineral Area College

Sterile Compounding Personnel
Clean room access is limited to those personnel trained to prepare CSPs. No cosmetics, perfume, hair spray, artificial nails, or nail polish can be worn while performing sterile compounding procedures. Individuals with certain medical conditions (respiratory infections, weeping sores, rashes, and sunburn) are banned from the sterile compounding area. No food or beverages in the anteroom or clean room; no horseplay and no gum. Created by Jennifer Majeske, Mineral Area College

Garbing of Sterile Compounding Personnel
Strict sequence, moving from the most dirtiest (shoe covers on shoes) to the cleanest item (donning sterile gloves). Personnel must remove all outwear (coats, sweaters, hats, etc.), prior to entering the ante area. Shoe Covers: placed over the technician’s closed-toed shoes to keep dirt and other substances from contaminating the floor of the clean room. Created by Jennifer Majeske, Mineral Area College

Garbing of Sterile Compounding Personnel
Hair Cover: secured to the head; avoids contamination of the hood or CSP. Face Mask: covers nose and mouth during compounding; catches bacteria contained in the liquid droplets and aerosols that emanate from the nose and mouth. Created by Jennifer Majeske, Mineral Area College

Aseptic Hand Washing Aseptic hand washing must be performed using an acceptable cleansing agent such as chlorhexidine gluconate. Aseptic hand washing procedures are rigorous and require personnel to follow a specific sequence; the sequence lasts 2-4 minutes. Gowning and Gloving: last two procedures before beginning sterile compounding. Gowning: sterile, disposable, nonshedding gown. Created by Jennifer Majeske, Mineral Area College

Aseptic Hand Washing Gowning and Gloving: last two procedures before beginning sterile compounding. Gowning: sterile, disposable, nonshedding gown. Gloving: sterile, powder-free gloves; disinfect the gloves with 70% isopropyl alcohol every time gloves touch a nonsterile surface. Created by Jennifer Majeske, Mineral Area College

Other Garbing Regulations
Specific situations regarding garbing, address by USP Chapter <797> guidelines. Repeating the entire garbing and hand-washing process after leaving the clean room, but the same gown can be worn again upon return to the clean room. Double gloving – wearing a second pair of gloves, is done when a technician is working with hazardous drugs. Created by Jennifer Majeske, Mineral Area College

Contamination Risk Levels
Risk levels are assigned based on the probability of microbial, chemical, or physical contamination. Expiration date: shelf life. Beyond-use date is for a compounded product. Low-risk CSPs: sterile products that have been manipulated using aseptic technique for a single-volume transfer. Medium-risk CSPs: multiple sterile products combined using automated devices. High-risk CSPs: products that have been compounded from nonsterile ingredients and sterile products w/o preservatives. Immediate-use CSPs: any CSPs made outside of a Class 5 ISO. Created by Jennifer Majeske, Mineral Area College

Training Required to Work with CSPs
Technicians working in the hospital pharmacy IV are hold important and responsible position. Skills and experience are necessary to practice in a clean-room environment. Written tests and skill assessments must be passed to meet USP guidelines and Joint Commission accreditation standards. Additional certifications and experience for technicians if often rewarded in salary. Created by Jennifer Majeske, Mineral Area College

Infection Control Committee
Infection control is the responsibility of all healthcare workers. Infection Control Committee (ICC) – is responsible for implementing CDC and USP guidelines and oversees training of all healthcare workers. The ICC monitors the incidence of HAIs and the proper use of antibiotics within the hospital. The ICC plays a major role in ensuring that the hospital is in compliance with the Joint Commission. Generally made up of physicians, nursing staff, infection control practitioners, and many others. Created by Jennifer Majeske, Mineral Area College

Role and Responsibilities of the ICC
The primary role of the ICC is to prevent, identify, and control healthcare associated infections (HAIs). Nosocomial infection: healthcare-associated infection occurs when bacteria found in the hospital from any sources can cause a patient to develop an infectious disease. 2 million patients develop new infections in the hospital each year, according to the CDC. HAIs result in additional costs from extended hospital stays to antibiotics. Created by Jennifer Majeske, Mineral Area College

Roles and Responsibilities of the ICC
Infection control policy include: Surveillance of nosocomial infections, antibiotic and other product evaluations, investigation of infection outbreaks and infection clusters, development of infection control procedures, patient education The committee may evaluate which disinfectant should be used. Educational programs are conducted for hospital employees including proper handling and disposal of medical waste, and discarding of sharps into a special container. Created by Jennifer Majeske, Mineral Area College

Implementation of Universal Precautions
Due to exposure to blood and bodily fluids the ICC oversees the implementation and training of personnel in universal precautions. Universal precautions: procedures to prevent such infection as a result of exposure to blood or other bodily fluids. Table 10.4 Universal Precautions Following procedures outlined in this chapter protects personnel and patients from unnecessary risk of infection. Created by Jennifer Majeske, Mineral Area College

This workforce solution was funded by a grant awarded by the U.S. Department of Labor’s Employment and Training Administration. The solution was created by the grantee and does not necessarily reflect the official position of the U.S. Department of Labor. The Department of Labor makes not guarantees, warranties, or assurances of any kind, express or implied, with respect to such information, including any information on linked sites and including, but not limited to, accuracy of the information or tis completeness, timeliness, usefulness, adequacy, continued availability, or ownership. This work by Mineral Area College is licensed under the Creative Commons Attribution 4.0 International License. Created by Jennifer Majeske, Mineral Area College

Resources Slide 9 Five second rule by Greg Williams licensed under CC BY Slide 12 Cryptococcosis by Pulmonary Pathology licensed under CC BY Slide 13 Protozoa by Picturepest licensed under CC BY Slide 27 Hand washing sign with soap by Simon Berry licensed under CC BY Hand Hygiene Saves Lives by Centers for Disease Control and Prevention (CDC) Created by Jennifer Majeske, Mineral Area College

Created by Jennifer Majeske, Mineral Area College

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