Infection Control and Prevention

Healthcare-associated infections (HAIs) pose significant risks to both patients and healthcare personnel� Healthcare organizations must adhere to current Centers for Disease Control and Prevention (CDC) guidelines concerning infection prevention and control� The Occupational Safety and Health Administration (OSHA) mandates organizations take specific actions to minimize employee exposures to bloodborne pathogens� Healthcare safety personnel should work closely with the infection control and prevention staff on issues of joint concern such as compliance with the OSHA Bloodborne Pathogens Standard (29 CFR 1910�1030)� Healthcare personnel must strive to minimize their exposure risks to blood, sputum, aerosols, and other body fluids by following proper work practices and using personal protective equipment (PPE)/clothing� The use of appropriate PPE, along with relevant education and training, provides the foundation for infection prevention� Any effective infection control and prevention function should stress personal hygiene, individual responsibility, surveillance monitoring, and investigation of infectious diseases and pathogens� Efforts should emphasize identifying infection risks, instituting preventive measures, eliminating unnecessary procedures, and preventing the spread of infectious diseases through the healthcare facility� Facilities should develop and implement plans to prevent and control infections by focusing on

• Integrating infection control into safety and performance improvement efforts • Assessing risks for the acquisition or transmission of infectious agents within the facility • Using an epidemiological approach to focus on surveillance and data collection data • Implementing infection prevention and control processes based on sound data • Coordinating plan design and implementation with key leaders • Establishing coordinated processes to reduce the risks of organization-acquired infections • Appointing one or more qualified individuals to lead facility efforts • Reporting information about infections both internally and to public health agencies

BOX 7.1 INFECTION CONTROL PLAN DEVELOPMENT CONSIDERATIONS

• Device-related, intravascular devices, ventilators, and tube-feeding infections • Surgical-site infections and HAIs in special care units • Infections caused by organisms that are antibiotic resistant • Tuberculosis and other communicable diseases • Infections in the neonate population • Geographic location of the facility • Volume of patient or resident encounters • Patient populations served • Clinical focus of the facility • Number of employees and staff

• Designing processes to reduce rates or trends of epidemiologically significant infections • Implementing strategies to reduce risks and prevent transmission of infections • Adopting strategies that consider scientific knowledge, practice guidelines, laws, or

regulations • Considering endemic rates and epidemic rates when analyzing data • Ensuring management systems support infection control objectives • Stressing risk identification using surveillance, prevention, and control activities • Coordinating with external organizations to reduce infections from the environment

Healthcare organizations should establish a comprehensive written policy regarding immunizing personnel, develop a listing of all required and recommended immunizations, and refer all staff to the employee health function to receive education about needed immunizations appropriate for their positions� The employee health function should consider medical history and job position exposure risk to determine needed vaccinations�

Healthcare personnel should meet the Advisory Committee for Immunization Practice (ACIP) guidelines for immunization against mumps, rubella, diphtheria, and measles� Consider the need for the following vaccinations:

• Rubella: Require for individuals considered at risk, including those with direct contact with pregnant patients�

• Hepatitis B: Offer all staff members with any potential exposure to bloodborne pathogens the vaccine within 10 days of their job assignment as mandated by OSHA�

• Measles: Consider immunization for persons susceptible by history or serology� • Influenza: Healthcare personnel should receive flu immunization to help prevent spread

of influenza�

Healthcare organizations must develop comprehensive policies and protocols for management and control of outbreaks of vaccine preventable diseases as described in the ACIP Guidelines� Healthcare employees working abroad should consider vaccinations for diseases such as hepatitis A, poliomyelitis, encephalitis, meningitis, plague, rabies, typhoid, and yellow fever� Healthcare organizations should develop written policies regarding work restrictions or exclusion from duty for immunization and infection control reasons� Require healthcare staff members to report any illnesses, medical conditions, or treatments that could make them susceptible to opportunistic infections�

BOX 7.2 HEALTHCARE VACCINE CATEGORIES

• Strongly Recommended: Diseases posing special risks including hepatitis B, influenza, measles, mumps, rubella, and varicella�

• Recommended in Some Situations: Active and/or passive immunizations as indicated by job circumstances to prevent occurrences of tuberculosis, hepatitis A, meningitis, and typhoid fever�

• Recommended for All Adults: Immunization for tetanus, diphtheria, and pneumonia disease�

The CDC publishes guidelines, advisories, and recommendations that do not carry the force of law� The CDC bases their guidance and recommendations on scientific studies� However, some infection control practices applicable to one setting may not apply in all healthcare situations� The guidance offered by the CDC gives healthcare infection control personnel the information necessary to make informed decisions� Organizations must provide proper education and training on current infection control and prevention practices including the latest OSHA requirements and CDC recommendations�

The continuous evaluation of care practices under the supervision of the infection control staff can help ensure continued adherence to correct practices� The Association for Professionals in Infection Control and Epidemiology (APIC) publishes up-to-date articles and guidelines on healthcare infection control�

CDC guidelines highly recommend the placement of alcohol-based hand-rub solutions in convenient locations of patient care areas of healthcare organizations� Clinical studies indicate that the frequency of handwashing relates to the accessibility of hand-hygiene facilities� Installing hand-rub dispensers immediately outside patient or resident rooms or within suites of rooms improves the overall efficacy of staff use by over 20%�

The guidelines provide excellent information on maintaining a safe healthcare environment and include infection control tips to follow during inspection, construction, or renovation activities in patient care and treatment areas� The guidelines provide a comprehensive review of the relevant literature with a focus on conducting a risk assessment before undertaking any activities that could generate dust or water aerosols� The guidelines also review infection control measures for catastrophic events such as flooding, sewage spills, and loss of utilities, including ventilation� Environmental infection control procedures must consider disease transmission via surfaces, laundry, plants, animals, medical wastes, cloth furnishings, and carpeting� These guidelines do not apply to sick buildings, terrorism, or food safety� Key suggestions include

• Evaluating the impact of activities on ventilation and water systems • Creating a multidisciplinary team to conduct infection control risk assessment • Using dust-control procedures and barriers during construction activities • Implementing special control measures in any areas with patients at high risk • Using air sampling to monitor air filtration and dust-control measures • Controlling tuberculosis risks in operating rooms when infectious patients require surgery • Culturing water as part of a control plan for Legionella if appropriate • Recovering from water system disruptions, leaks, and natural disasters • Disinfecting surfaces to control antibiotic-resistant microorganisms • Developing specific infection-control procedures for laundries • Establishing control procedures for using animals in activities and therapy • Managing the use of all service animals in healthcare facilities • Developing strategies for animals receiving treatment in human facilities • Measuring water use from main lines for dialysis, ice machines, hydrotherapy, dental

water lines, and automated endoscope reprocessing equipment

Other CDC Infection Control Guidelines include

• CDC Position Statement on Reuse of Single Dose Vials (2012) • Basic Infection Control and Prevention Plan for Outpatient Oncology Settings (October 2011)

• Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care (July 2011)

• CDC Issues Checklist for Infection Prevention in Out-Patient Settings to Accompany New Guide (July 2011)

• Guideline for the Prevention and Control of Norovirus Gastroenteritis Outbreaks in Healthcare Settings (2011)

• Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) • Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in

Healthcare Settings (2007) • Guideline-Management of Multidrug-Resistant Organisms in Healthcare Settings (2006) • Public Reporting of Healthcare-Associated Infections (2005) • Bloodstream Infection: Guideline for the Prevention of Intravascular Catheter-Related

Infections (2011) • Dialysis-Multi-Dose Vials Infection Control (2008) • Environmental Infection Control (2003) • Hand Hygiene (2002) • Infection Control-Healthcare Personnel (1998) • Occupational Exposures (2005) • Pneumonia (2003) • Surgical Site Infection (1999) • Guidelines for Preventing Transmission of Mycobacterium Tuberculosis in Healthcare

Facilities (2005) • Urinary Tract Infection (2009)

Consider handwashing as the first line of defense in preventing exposures to diseases, bloodborne pathogens, and infections� The CDC’s Standard Precautions provide the major features of blood and body fluid precautions designed to reduce the risk of transmission of bloodborne pathogens� Use the Standard Precautions to reduce the risk of transmission of microorganisms from both recognized and unrecognized sources of infection in hospitals� After using the Standard Precautions, facilities should then apply the appropriate Tiered Precautions for airborne, droplet, and contact routes of infection� Facilities should learn to recognize the pathogenic risk of body fluids, secretions, and excretions and should take precautions against the various routes of transmission by designing processes that eliminate confusion with regard to infection control or isolation requirements� Facilities should refer to the guidelines for information on clinical syndromes and empiric precautions� They should also adhere to specific transmission precautions for patients colonized with pathogens� CDC’s tier precautions provide guidelines with regard to

• Handwashing, glove use, and patient placement procedures, including transport • Use of masks, gowns, and other protective apparel • Procedures for patient care equipment, linen, and laundry • Cleaning dishes, glasses, cups, and eating utensils

Federal, state, and local health agencies publish rules and guidelines that define isolation procedures� Healthcare organizations should follow these guidelines because several routes can transmit infectious agents:

• Contact: Contamination due to close proximity with persons with a contagious disease • Indirect contact: Contamination by contacting an object contaminated by an infected person

• Droplet: Contamination caused by a person sneezing, coughing, or talking • Common vehicle: Disease spread by food, water, drugs, devices, or equipment • Airborne: Air-suspended infectious nuclei or dust that could be inhaled or digested • Vector-borne: Organisms carried by animals or insects

3. Airborne Precautions Airborne precautions reduce the risk of airborne transmission of infectious agents disseminated by airborne droplet nuclei (small-particle residue 5 micrometers or smaller), evaporated droplets that may remain suspended in the air for long periods of time, or dust particles containing the infectious agent� Microorganisms disperse widely by air currents and may become inhaled or deposited on a susceptible host within the same room� Depending on environmental factors, use special air handling and ventilation to prevent airborne transmission� Airborne precautions apply to patients with known or suspected pathogens such as measles, varicella, and tuberculosis�

4. Droplet Precautions Droplet precautions reduce the risk of droplet transmission of infectious agents� Droplet transmission involves contact of the conjunctive or mucous membranes of the nose or mouth of a susceptible person with large-particle droplets (larger than 5 micrometers)� The droplets contain microorganisms generated from a person with a clinical disease or who serves as a carrier of the microorganism� Droplets generated from the source person during coughing, sneezing, or talking and during performance of certain procedures such as suctioning and bronchoscopy can result in exposure risks� Transmission of a disease via large-particle droplets requires close contact between the source and recipient� Droplets do not remain suspended in the air and generally travel only short distances (3 feet or less)� Special air handling and ventilation is not required to prevent droplet transmission� Droplet precautions apply to any patient with known or suspected infections such as meningitis, pneumonia, sepsis, pharyngeal diphtheria, Mycoplasma pneumonia, pertussis, streptococcal group A pharyngitis, scarlet fever, Rubella, and pneumonic plague�

5. Contact Precautions Contact precautions reduce the risk of transmission of epidemiologically important microorganisms by direct or indirect contact� Direct contact transmission involves skin-to-skin contact or the physical transfer of microorganisms to a susceptible host� This can occur when caregivers turn patients, bathe patients, or perform other patient-related activities with physical contact� Direct contact transmission can also occur between patients� Indirect contact transmission involves contact of a susceptible host with a contaminated object or surface in the patient environment� Contact precautions apply to specific patients with a known or suspected infection with epidemiologically important microorganisms transmitted by contact via gastrointestinal tracts, respiratory systems, skin surfaces, wounds, and multidrug-resistant bacteria� Use contact precautions for hepatitis A, contagious skin infections, herpes simplex viruses, scabies, and viral or hemorrhagic infections�

The CDC recently released information that four percent of U�S� hospitals and 18 percent of nursing homes had treated at least one patient with the bacteria called carbapenem-resistant Enterobacteriaceae (CRE) during the first six months of 2012� CRE are in a family of more than 70 bacteria called enterobacteriaceae, including Klebsiella pneumoniae and E. coli, that normally live in the digestive system� In recent years, some of these bacteria became resistant to last-resort antibiotics known as carbapenems� Most CRE infections occur in patients with prolonged stays in hospitals, long-term facilities, and nursing homes� These bacteria can kill up to 50 percent of infected patients� According to the CDC, these bacteria can easily spread from patient to patient on the hands of caregivers� CRE bacteria can transfer their antibiotic resistance to other bacteria of

the same type� To reduce spread of these bacteria, the CDC wants hospitals and other healthcare facilities to take the following steps:

• Enforce infection-control precautions • Group together patients with CRE • Segregate staff, rooms, and equipment with CRE patients • Inform facilities about the transfer of patients with CRE • Use antibiotics carefully

On February 8, 2006 the President signed the Deficit Reduction Act (DRA) of 2005, which required there be an adjustment in Medicare Diagnosis Related Group (DRG) payments for certain hospitalacquired conditions (HACs) with a component that addresses new Present on Admission (POA) coding� Section 5001(c) of the DRA required the Secretary to identify, by October 1, 2007, at least two conditions for which hospitals under the Inpatient Prospective Payment System (IPPS) would not receive additional payment beginning on October 1, 2008, if the condition was not POA� The conditions must involve high cost or high volume or both and result in the assignment of a case to a DRG with a higher payment when present as a secondary diagnosis� Preventing the incident could reasonably occur through the use of evidence-based guidelines� For discharges occurring on or after October 1, 2008, hospitals would not receive additional payment for cases in which one of the selected HACs was not POA� HACs for potential reduced payment include the following infections:

• Catheter-associated urinary tract infections� Note: ICD-9 coding does not distinguish between catheter-associated infection and inflammation�

• Vascular catheter-associated blood stream infection (BSI)� The Centers for Medicare & Medicaid Services (CMS) developed a specific code for central-line vascular catheters (CVC) and CVC-BSI is not limited to the intensive care unit (ICU)�

• Surgical-site infection mediastinitis occurring after coronary artery bypass grating (CABG) surgery�

• Orthopedic surgeries involving spinal fusion and other surgeries of the shoulder and elbow • Bariatric surgery for morbid obesity including laparoscopic gastric bypass and gastro-

enterostomy

We can divide chemical germicides into three general categories:

• Sterilizing agents, used to eliminate all microbial life on objects or surfaces, including bacterial spores that can survive other germicides

• Disinfectants, classified as high, medium, or low, depending on the strength required, and which can destroy nearly all microbial life on objects or surfaces except for bacterial spores

• Antiseptics, used to inactivate or destroy organisms on skin or living tissue

Bacterial spores exhibit the most resistance to germicides, followed by myco-bacteria, nonlipid viruses, fungi, and vegetative bacteria� Lipid viruses exhibit the least resistance� Facilities

should use Food and Drug Administration (FDA)- or EPA-approved cleaning agents and should read and follow the manufacturer’s instructions to ensure proper use� Their effectiveness depends on

• Shape and texture of surface • Amount of contamination on the surface • Resistance of contaminants to the germicide • Amount of soil buildup, including blood, mucous, or tissue • Chemical composition of the germicide • Time of exposure to the germicide • Temperature of the germicide

The EPA oversees the manufacture, distribution, and use of disinfectants� Manufacturers must use pre-established test procedures to ensure product stability, determine toxicity to humans, and assess microbial activity� If the product passes these requirements, the EPA registers the substance for use� The EPA regulates disinfectants under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)� The FDA regulates liquid chemical sterilants and high-level disinfectants such as hydrogen peroxide and peracetic acid under the authority of the Medical Devices Amendment to the Food, Drug, and Cosmetic Act of 1976� The FDA regulates the chemical germicides if marketed for use on specific medical devices� Regulatory authority requires the manufacturer to provide instructions for the safe and effective use of substances with that device� The FDA uses the same basic terminology and classification scheme as does the CDC, which categorizes medical devices as critical, semicritical, and noncritical� The scheme classifies antimicrobial effectiveness or sterilization as high, intermediate, and low level�

The EPA registers environmental surface disinfectants based on the manufacturer’s microbiological activity claims� The EPA does not use the terms “intermediate level” and “low level” when classifying disinfectants� The CDC designates any EPA-registered hospital disinfectant without a tuberculocidal claim as a low-level disinfectant� Consider an EPA-registered hospital disinfectant effective against tuberculosis as an intermediate-level disinfectant� The EPA also lists disinfectant products according to their labeled use against certain organisms� OSHA requires the use of EPAregistered hospital tuberculocidal disinfectants or EPA-registered hospital disinfectants labeled effective against human immunodeficiency virus (HIV) and hepatitis B virus (HBV) for decontaminating work surfaces� Hospitals can use disinfectants with HIV and HBV claims if surfaces contain no contamination requiring the use of a higher-level disinfectant�

All of EPA’s registered pesticides must possess an assigned EPA Product Registration Number� Alternative brand names possess the same EPA Product Registration Number as the primary product name� The EPA Product Registration Number remains the key way to identity the substance� An EPA Establishment Number refers to the production location� A formulation or device uses a set of codes that consist of the registrant’s ID Number followed by the state where produced and Facility Number� The EPA updates their registered disinfectant lists periodically to reflect label changes, cancellations, and transfers of product registrations� Information on the following list does not constitute a label replacement� Inclusion of products in these lists does not constitute an endorsement of one product over another� The EPA organizes the lists alphabetically by product names and by numerical order of their EPA Registration Numbers�

The CDC does not test, evaluate, or otherwise recommend specific brand-name products of chemical germicides� The CDC recommends disinfecting environmental surfaces or sterilizing or disinfecting medical equipment with products approved by the EPA and FDA� When no registered or approved products are available for a specific pathogen or use situation, the CDC suggests following specific guidance regarding unregistered uses for various chemical germicides� No antimicrobial products hold registered status for use against severe acute respiratory syndrome (SARS), Norwalk virus, or Creutzfeldt-Jakob disease agents�

Healthcare facilities use a number of disinfectants, including alcohol, chlorine, chlorine compounds, hydrogen peroxide, phenolic substances, and quaternary ammonium compounds� Never routinely interchange disinfectants� Proper selection and use of disinfectants provide the key to effective safety and quality control� Alcohols demonstrate variable effectiveness against some bacteria and fungi� Alcohols act fast, leave no residue, and can compatibly combine with other disinfectants such as quaternaries, phenolic substances, and iodine to form tinctures� Aldehydes can prove effective against a wide spectrum of bacteria and viruses, including spores, when used properly� They also

BOX 7.3 EPA REGISTRATION CATEGORIES

• List A: EPA’s Registered Antimicrobial Products as Sterilizers • List B: EPA’s Registered Tuberculocide Products Effective Against Mycobacterium

tuberculosis (TB) • List C: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1

Virus • List D: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1

and HBV • List E: EPA’s Registered Antimicrobial Products Effective Against TB, HIV-1, and

HBV • List F: EPA’s Registered Antimicrobial Products Effective Against Hepatitis C Virus

(HCV) • List G: EPA’s Registered Antimicrobial Products Effective Against Norovirus • List H: EPA’s Registered Antimicrobial Products Effective Against Methicillin-

Resistant Staphylococcus aureus (MRSA) and Vancomycin-Resistant Enterococcus faecalis or faecium (VRE)

• List J: EPA’s Registered Antimicrobial Products for Medical Waste Treatment • List K: EPA’s Registered Antimicrobial Products Effective Against Clostridium

difficile Spores

BOX 7.4 CDC DISINFECTING LEVELS

• High-level disinfection processes can expect to destroy all microorganisms with the exception of high numbers of bacterial spores�

• Intermediate-level disinfection inactivates Mycobacterium tuberculosis, vegetative bacteria, most viruses, and most fungi but does not necessarily kill bacterial spores�

• Low-level disinfection can kill most bacteria, some viruses, and some fungi but does not kill resistant microorganisms such as tubercle bacilli or bacterial spores�

demonstrate activity against other pathogens, including vegetative bacteria and viruses� Chlorine works very well for cleaning up blood or body-fluid spills� Chlorine compounds work as effective biocides on tuberculosis and vegetative bacteria� Chlorine compounds prove effective against HIV after 10 to 20 minutes and demonstrate effectiveness at a 1:5 dilution against bacterial spores and mycobacteria� Diluted chlorine neutralizes rapidly in the presence of organic matter� Chlorine compounds work very well for the decontamination of HBV, HCV, and cleanup of biohazardous spills�

On November 6, 2000, the President signed the Needlestick Safety and Prevention Act (Pub� L� 106-430)� The Act required OSHA to revise the OSHA Bloodborne Pathogens standard within six months of enactment of the Act� To facilitate expeditious completion of this directive, Congress explicitly exempted OSHA from procedural requirements generally required under the rule-making provision of the act (paragraph 6(b)) and from the procedural requirements of the Administrative Procedure Act (5 U�S�C� 500 et seq�)� The Bloodborne Pathogens standard sets forth requirements for employers with employees exposed to blood or other potentially infectious materials� In order to reduce or eliminate the hazards of occupational exposure, an employer must implement an exposure control plan for the worksite with details on employee protection measures� The plan must also describe how an employer will use a combination of engineering and work practice controls, ensure the use of personal protective clothing and equipment, and provide training, medical surveillance, hepatitis B vaccinations, and signs and labels, among other provisions�

Engineering controls provide the primary means of eliminating or minimizing employee exposure and include the use of safer medical devices, such as needleless devices, shielded needle devices, and plastic capillary tubes� Many different medical devices can now reduce the risk of needle sticks and other sharps injuries� These devices replace sharps with nonneedle devices or incorporate safety features designed to reduce injury� Despite advances in technology, needle sticks and other sharps injuries continue to occur at high rates� The revised OSHA standard became effective April 18, 2001, adding new requirements for employers, including additions to the exposure control plan and keeping a sharps injury log� It did not impose any new requirements for employers to protect employees from sharps injuries� The original standard already required employers to adopt engineering and work practice controls that would eliminate or minimize employee exposure from hazards associated with bloodborne pathogens� The revision requires organizations to implement engineering controls such as using safer medical devices to reduce or eliminate exposure risks� Exposure control plan requirements must make clear that employers must implement safer medical devices proven appropriate, commercially available, and effective� Organizations must get input on selecting devices from those responsible for direct patient care� The updated standard also requires employers to maintain a log of injuries occurring from contaminated sharps�

The revision included new requirements regarding the employer’s exposure control plan, including an annual review and update to reflect changes in technology that eliminate or reduce exposures to bloodborne pathogens� The employer must

• Consider new innovations in medical procedures and technology that reduce the risk of exposure to needle sticks

• Consider and document use of appropriate, commercially available, and effective safer needles

• Realize that no single medical device can prove effective for all circumstances • Identify devices used, the method in place to evaluate those devices, and justification for

the eventual selection

• Select devices based on reasonable judgment, but never jeopardize patient or employee safety

• Select devices that will make an exposure incident involving a contaminated sharp less likely to occur

The OSHA Bloodborne Pathogen Standard requires that personnel wash their hands immediately or as soon as feasible after removal of gloves or other PPE� OSHA requires that employees wash their hands and any other skin with soap and water or flush mucous membranes with water immediately or as soon as feasible following contact of such body areas with blood or other potentially infectious materials� Personnel removing gloves after exposure to blood or other potentially infectious materials must wash their hands using an appropriate soap and running water� Staff members with no access to a readily available sink after an exposure may decontaminate hands with a hand cleanser or towelette� However, staff must wash their hands with soap and running water as soon as feasible� If no exposure or contact occurs with blood or other potentially infectious materials, consider use of alcohol-based hand cleansers as appropriate� Use alcohol based sanitizing solutions when the location does not support handwashing facilities� Use a sanitizer with an alcohol concentration of 62% or greater� It is important to note the hand sanitizers are effective against common diseases, but they are ineffective against certain organisms such as bacterial spores� Never use sanitizers as a substitute for soap and water� Research shows that with just three applications of an alcohol-based sanitizer, the effectiveness of the sanitizer decreases� The reason for the decreased effectiveness is alcohol in the sanitizers can remove natural oils from your hands, which will cause your hands to dry out and crack�

Employers must solicit input from nonmanagerial employees responsible for direct patient care regarding the identification, evaluation, and selection of effective engineering controls, including safer medical devices� Employees selected should represent the range of exposure situations encountered in the workplace, such as those in geriatric, pediatric, or nuclear medicine and others involved in the direct care of patients� OSHA will check for compliance with this provision during inspections by questioning a representative number of employees to determine if and how their input was requested� Employers must document in the exposure control plan how they received input from employees� Organizations can meet this obligation by listing the employees involved and describing the process used to obtain their input� Employers can also present other documentation, including references to the minutes of meetings, copies of documents used to request employee participation, or records of responses received from employees�

Employers with employees experiencing occupational exposure to blood or other potentially infectious materials must maintain a log of occupational injuries and illnesses under existing recordkeeping rules, but must also maintain a sharps injury log� Maintain this log in a manner that protects the privacy of employees� The sharps injury log may include additional information that the employer must protect due to privacy requirements� Employers can determine the format of the log� At a minimum, the log must contain the following:

• Type and brand of device involved in the incident • Location of the incident • Description of the incident

Engineering controls include all control measures that isolate or remove a hazard from the workplace, such as sharps disposal containers and self-sheathing needles� The original Bloodborne Pathogens standard was not specific regarding the applicability of various engineering controls (other than the above examples) in the healthcare setting� The revision now specifies that safer medical devices, such as sharps with engineered sharps injury protection and needleless systems, constitute an effective engineering control� The phrase “sharps with engineered sharps injury protection” describes nonneedle sharps or needle devices containing built-in safety features used for collecting fluids and administering medications or other fluids� It can also describe other procedures involving the risk of sharps injury� This description covers a broad array of devices including

• Syringes with a sliding sheath that shields the attached needle after use • Needles that retract into a syringe after use • Shielded or retracting catheters • Intravenous medication (IV) delivery systems that use a catheter port with a needle housed

in a protective covering

The term “needleless systems” refers to any devices that provide an alternative to needles for procedures with a risk of injury involving contaminated sharps� Examples include intravenous medication systems that administer medication or fluids through a catheter port using nonneedle connections� Consider jet injection systems, which deliver liquid medication beneath the skin or through a muscle, as another example�

Exposure determination involves listing all job classifications in which employees could encounter potential exposure� This includes physicians, nurses, and other clinical personnel� Maintenance, environmental services, and laundry personnel can work in situations that could pose exposure risks� List any specific procedures or tasks in which exposure could occur without regard to the use of PPE�

Employers should take appropriate preventative measures against occupational exposure� These include engineering controls and work practice controls� Examples of engineering controls include biohazard hoods, puncture-resistant sharps containers, mechanical pipette devices, and other devices that permanently remove the hazard or isolate individuals from exposure� Organizations must evaluate and incorporate new safer devices, including needleless devices, needles with sheaths, and blunt suture needles� Work practice controls must include handwashing policies, sharps handling procedures, proper waste disposal techniques, and other actions that would reduce the likelihood of exposure�

Employers must provide PPE to all personnel with occupational exposure� Select personal protective equipment that does not permit blood or other potentially infectious materials to pass through or reach a person’s outer clothing, undergarments, skin, eyes, mouth, or other mucous membranes� Ensure personnel wear gloves when hand contact occurs with blood or other potentially infectious

materials� Replace disposable gloves as soon as possible when contaminated or no longer in condition to provide barrier protection� Decontaminate reusable utility gloves and discard immediately if cracked, discolored, or punctured, or if they show signs of deterioration� Require personnel to wear masks, eye protection, and face protection when exposed to potentially infectious splashes, spray, or droplets� Require the use of gowns, aprons, and other clothing to protect against anticipated exposure to the body, head, and feet�

Employers should create a schedule for periodic cleaning and appropriate disinfecting to ensure that the worksite remains clean and sanitary� Personnel should place and transport contaminated laundry in properly labeled or color-coded bags and containers� They should disinfect contaminated work surfaces after completing the task� Clean surfaces contaminated by splashes or spills and when they come into contact with blood or other potentially infectious materials� Clean the area at the end of the work shift� Place all blood or infectious materials, contaminated items that could release infectious materials, or contaminated sharps in appropriate sharps containers or closable, color-coded, or properly labeled leak-proof containers or bags� Dispose of infectious waste in accordance with federal, state, and local regulations� Attach warning labels to all containers used for the storage or transport of potentially infectious materials� Use labels of orange or red-orange color with the biohazard symbol in a contrasting color� Employers can substitute red containers or bags for warning labels�

HBV causes an estimated two million deaths annually worldwide, establishes a carrier state in many victims, and generally produces some jaundice along with many acute symptoms such as (1) painful joint aches, (2) significant skin rashes, and (3) serve liver damage mediated by host immune reactions to the presence of HBV particles� If jaundice appears, it can persist for two to six weeks� HBV infection can cause severe fatigue and weakness, brown urine, and pale stools� The virus that causes HBV is found in blood and other body fluids, including semen, vaginal secretions, urine, and even saliva� Most people recover, but up to 10 percent become chronic carriers� These chronic carriers can spread the disease to others for an indefinite period of time and create a high risk for other diseases including cirrhosis of the liver and primary liver cancer� Although the blood and blood products provide the key transmission vehicle, viral antigen can also appear in tears, saliva, breast milk, urine, semen, and vaginal secretions� The virus can survive for seven days or more on environmental surfaces exposed to body fluids containing the virus� Infection may occur when the virus transmitted by infected body fluids or implanted via mucous surfaces becomes introduced through breaks in the skin�

1. Hepatitis B Vaccination All healthcare personnel with potential exposure to blood, blood-contaminated body fluids, other body fluids, or sharps should receive a vaccination� Administer the hepatitis B vaccine using the intramuscular route in the deltoid muscle� The OSHA Bloodborne Pathogens standard requires employers to offer the hepatitis B vaccine free of charge to all potentially exposed employees within 10 days of hire� Administer post-exposure prophylaxis with hepatitis B immunoglobulin (passive immunization) and/or vaccine (active immunization) when indicated after per-cutaneous or mucous membrane exposure to blood known or suspected to contain hepatitis B� Needle-stick or other percutaneous exposures of unvaccinated persons should lead to initiation of the hepatitis B vaccine series� HBV vaccination requirements are as follows:

• OSHA requires employers to offer the HBV vaccination series to all personnel with potential occupational exposure to blood or other potentially infectious material within 10 days of hire�

• Employers should always follow U�S� Public Health Service and CDC recommendations for hepatitis B vaccination, serologic testing, follow-up, and booster dosing�

• Employers should test personnel for anti-HBs 12 months after completion of the three doses�

• Healthcare staff members should complete a second three-dose vaccine series or receive evaluation to determine if HBV-positive (if no antibody response occurs to the primary vaccine series)�

• Retest personnel for anti-HBs at the completion of the second vaccine dose� If no response to the second three-dose series occurs, retest nonresponders for HBV�

• Before vaccinating HBV negative nonresponders, counsel them regarding their susceptibility to HBV infection and precautions�

• Employers should provide employees with appropriate education regarding the risks of HBV transmission and availability of the vaccine� Employees who decline the vaccination should sign a declination form� Employers must maintain the form�

• Make the vaccination available without cost to the employee, at a reasonable time and place for the employee, by a licensed healthcare professional and according to recommendations of the U�S� Public Health Service, including routine booster doses�

• Provide the healthcare professional designated by the employer to implement this part of the standard with a copy of the Bloodborne Pathogens standard�

• The healthcare professional must provide the employer with a written opinion stating whether the hepatitis B vaccination is indicated for the employee and whether the employee received the vaccination�

Hepatitis C (HCV), a contagious liver disease, results from infection with the hepatitis C virus� It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness that damages the liver� Hepatitis C can occur in “acute” or “chronic” forms� Consider acute hepatitis C infection as a short-term illness that occurs within the first six months after exposure� Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection� For reasons unknown, 15 to 25 percent of people “clear” the virus without treatment and do not develop chronic infection� Chronic hepatitis C virus infection can progress into a long-term illness that occurs when the virus remains in a person’s body� Over time, it can lead to serious liver problems, including liver damage, cirrhosis, liver failure, or liver cancer� Before widespread screening of the blood supply began in 1992, hepatitis was also commonly spread through blood transfusions and organ transplants� Although rare, outbreaks of hepatitis C do occur from blood contamination in medical settings� Most people with hepatitis C present no symptoms� Symptoms can appear two weeks to six months after exposure� Symptoms can include fever, fatigue, no appetite, nausea, vomiting, abdominal pain and dark urine, clay colored bowel movements, joint pain, and jaundice�

BOX 7.5 WHEN THE HEPATITIS B VACCINATION IS NOT REQUIRED

• Employees previously completed the hepatitis B vaccination series • Immunity confirmed through antibody testing • Vaccine contraindicated for medical reasons • Following participation in a prescreening plan • Employees who decline the vaccination

Note: Employees who decline to accept the hepatitis B vaccination must sign a declination form indicating the employer offered the vaccination�

HIV affects the immune system, rendering the infected individual vulnerable to a wide range of disorders� Infections typically lead to the death of the patient� Symptoms can occur within a month and can include fever, diarrhea, fatigue, and rash� Exposed persons may develop antibodies and not present symptoms for months to years� The infected person may finally develop a wide range of symptoms depending on the opportunistic infections against which the body’s immune system cannot defend�

Employees should know what to do when confronted with an emergency involving blood or other potentially infectious materials, post-exposure evaluations, the HBV vaccine, and the use of signs and labels� After training, make vaccinations available to those who run the risk of exposure� Employers should establish a medical record for each employee with occupational exposure� Keep this record confidential and keep it separate from other personnel records� Employers can keep these records onsite or healthcare professionals providing services to the employees can retain the records� The medical record contains the employee’s name, Social Security number, HBV vaccination status, date of the HBV vaccination (if applicable), and the written opinion of the healthcare professional regarding the hepatitis B vaccination� Note any occupational exposure in the medical record to document the incident, and include the results of testing following the incident� The post-evaluation

BOX 7.6 HIV EXPOSURE AND TRANSMISSION ROUTES

• Contact with blood, semen, vaginal secretions, and breast milk • Sexual intercourse • Using needles contaminated with the virus • Contact with HIV-infected blood under the skin, mucous membranes, or broken skin • Mother-to-child contact at the time of birth • Blood transfusions or organ transplants

BOX 7.7 WORKPLACE TRANSMISSION OF HIV

• Body fluids such as saliva, semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, amniotic fluid, and any other body fluids visibly contaminated with blood

• Saliva and blood contacted during dental procedures • Unfixed tissue or organs other than intact skin from living or dead humans • Organ cultures, culture media, or similar solutions • Blood, organs, and tissues from experimental animals infected with HIV or HBV

BOX 7.8 MEANS OF TRANSMISSION

• Accidental injury with a sharp object contaminated with infectious material, such as needles, scalpels, broken glass, and anything that can pierce the skin

• Open cuts, nicks, skin abrasions, dermatitis, acne, and mucous membranes • Indirect transmission, such as touching a contaminated object or surface and trans-

ferring the infectious material to the mouth, eyes, nose, or open skin

written opinion of the healthcare professional becomes a part of the medical record� The medical record must document what information was provided to the healthcare provider� Maintain medical records for 30 years past the last date of employment of the employee� Ensure confidentiality of medical records� Never disclose a medical record or part of a medical record without direct written consent of the employee or as required by law� Keep training records for three years� Training records must include the date, content outline, trainer’s name and qualifications, and names and job titles of all persons attending the training sessions� Employers who cease to do business should transfer the medical and training records to the successor employer� Upon request, make both medical and training records available to the Assistant Secretary of Labor for Occupational Safety and Health� Make training records available to employee upon request� The employee or anyone given the employee’s written consent may obtain medical records�

OSHA’s Bloodborne Pathogens standard requires handwashing after removal of gloves or other PPE to help minimize the amount of powder or latex remaining in contact with the skin� Employees can develop latex sensitivity or latex allergy from exposure to latex in products such as latex gloves� The National Institute of Occupational Safety and Health (NIOSH) estimates that 8 to 12 percent of healthcare personnel may experience latex reactions ranging from contact dermatitis to possibly life-threatening sensitivity� Among the alternatives are synthetic, low-protein, and powder-free gloves� Powder-free gloves may reduce systemic allergic responses� Employees should never wear latex gloves when no risk of exposure to blood or other potentially infectious materials exists� Never assume hypoallergenic gloves, glove liners, or powder-free gloves are latex-free� Use good housekeeping practices to remove latex-containing dust from the workplace�

Frequently clean areas contaminated with latex dust such as upholstery, carpets, and ventilation ducts� Frequently change ventilation filters and vacuum bags used in latex-contaminated areas� Employ appropriate work practices to reduce the chance of reactions to latex such as not using oilbased hand creams or lotions, which can cause glove deterioration, unless shown to reduce latexrelated problems and maintain glove barrier protection� After removing latex gloves, wash hands with a mild soap and dry thoroughly�

All employees with occupational exposure must receive initial and annual training on the hazards associated with exposure to bloodborne pathogens� The training must also address the protective measures taken to minimize the risk of occupational exposure� Employers must conduct retraining when changes in procedures or tasks occur� Consider OSHA employee-training requirements as performance oriented� However, employers may tailor their presentations to the employees’ backgrounds and responsibilities� Ensure the training addresses the topics listed in paragraph (g)(2)(vii) of 29 CFR 1910�1030�

Employers must provide training at the time of initial employment and at least annually thereafter� Provide annual retraining for employees within one year of their original training date� Refresher training must cover topics listed in the standard to the extent needed and must emphasize new information or procedures� Employers must train part-time employees, temporary employees, and those referred to as “agency” or “per diem” employees� OSHA requires training to include an explanation of the use and limitations of methods that will prevent or reduce exposure, including appropriate engineering controls, work practices, and PPE� Training must include instruction in any new techniques and practices� Use hands-on training if possible�

1. Training Methods and Interactive Question Opportunities Training employees solely by means of a film or video without the opportunity for a discussion period would constitute a violation of 29 CFR 1910�1030(g)(2)� Never consider a computer program, even

an interactive one, as appropriate unless the employer supplements such training with the required site-specific information� Provide trainees with direct access to a qualified trainer during all training sessions� OSHA permits employers to meet the requirement if personnel can directly access a trainer by way of a telephone hotline� OSHA does not consider use of electronic mail systems to answer employee questions unless a trainer answers e-mailed questions at the time the questions arise�

2. Trainer Qualifications OSHA requires persons conducting training to possess knowledge in the subject matter covered by the elements contained in the training plan� The trainer must demonstrate expertise in the area of the occupational hazard of bloodborne pathogens and know local procedures� Trainers, such as infection control practitioners, registered nurses, occupational health professionals, physician’s assistants, emergency medical technicians, industrial hygienists, and professional trainers, may conduct the training, provided they know the subject matter covered in the training plan as it relates to the workplace� In dentist and physician offices, individual employers may conduct the training, provided they understand bloodborne pathogen exposure control and the subject matter required by the standard�

Medical recordkeeping, covered by 29 CFR 1910�1020(h), requires employers to keep medical and training records for each employee� OSHA permits employers not to retain medical records of employees working for less than a year if given to the employee upon termination of employment� Keep medical records confidential except for disclosures permitted by the standard or by other federal, state, or local laws� Make all medical records required by the standard available to OSHA� The Compliance Officer must protect the confidentiality of these records� If copied for the case file, follow the provisions of 29 CFR 1913�10� Consider records about employee exposure to bloodborne pathogens and documenting HIV/HBV status as medical records�

1. Training Recordkeeping OSHA requires accurate recordkeeping of training sessions, including titles of the employees who attend� The records assist the employer and OSHA in determining whether the training plan adequately addresses the risks involved in each job� Additionally, this information can prove helpful in tracking the relationship between exposure incidents and the corresponding levels of training� Store training records onsite to permit easy access� Do not consider training records as confidential� Retain training records for three years from the training date�

The standard covers all personnel expected to respond to emergencies caused by the uncontrolled release of a hazardous substance� The definition of hazardous substance includes any biological agent or infectious material that may cause disease or death� Potential scenarios where the Bloodborne Pathogens and Hazardous Waste Operations and Emergency Response (HAZWOPER) standards may interface include healthcare staff members responding to an emergency caused by the uncontrolled release of infectious material� Employers of employees engaged in these types of activity must comply with the requirements in 29 CFR 1910�120 as well as the Bloodborne Pathogens standard� If there is a conflict or overlap, the provision that is more protective of employee safety and health applies�

Employers should provide a confidential medical evaluation for any employees involved in an exposure incident� The evaluation documents the exposure route and all circumstances related to the

incident, including blood testing, HIV/HBV status of source, and appropriate medical/psychological treatment� An exposure incident can occur to a specific eye, the mouth, mucous membranes, nonintact skin, or any other contact with potentially infectious material that results from the performance of an employee’s duties� Employees should immediately report exposure incidents to permit timely medical evaluation and follow-up by a healthcare professional� The employer can request testing of the source individual’s blood for HIV and HBV� Consider a source individual as any patient whose blood or body fluids provide the source of an exposure incident to an employee� At the time of the exposure, the exposed employee must report to a healthcare professional� The employer must provide the healthcare professional with a copy of the Bloodborne Pathogens standard and a description of the employee’s job duties as they relate to the incident� The employer also must provide a report of the specific exposure, including route of exposure, relevant employee medical records (including hepatitis B vaccination status), and results of the source individual’s blood tests, if available� Draw a baseline blood sample if the employee consents� If the employee elects to delay HIV testing of the sample, the healthcare professional must preserve the employee’s blood sample for at least 90 days� Never repeat testing for known HIV-or HBV-positive individuals� Most states require written consent before testing� Treat the results of the source individual’s blood test as confidential� Make the results available to the exposed employee through consultation with the healthcare professional� The healthcare professional will provide a written opinion to the employer� The opinion can only provide a statement that the employee received the results of the evaluation� The employer must provide a copy of the written opinion to the employee within 15 days� This requirement remains the only information shared with the employer following an exposure incident� Treat all other employee medical records as confidential� Provide all evaluations and follow-up visits at no cost to the employee� They must take place at a reasonable time and place� Perform evaluations and follow-up visits under the supervision of a licensed physician or another licensed healthcare professional� All evaluations must follow the U�S� Public Health Service guidelines current at the time� Conduct all laboratory tests by using an accredited laboratory and at no cost to the employee�

Every healthcare setting should conduct initial and ongoing evaluations for risk of TB transmission� The TB risk assessment determines the types of administrative, environmental, and respiratoryprotection controls needed for a setting and serves as an ongoing evaluation tool of the quality of TB infection control and for the identification of needed improvements in infection-control measures� Review the community profile of TB disease in collaboration with the state or local health department� Consult the local or state TB-control plan to obtain epidemiologic surveillance data necessary to conduct a TB risk assessment for the healthcare setting� Review the number of patients with suspected or confirmed TB disease encountered in the setting during at least the previous five years� The screening plan should consist of four major components: (1) baseline testing for TB infection, (2) serial testing for TB, (3) serial screening for symptoms or signs of TB disease, and

BOX 7.9 EVALUATING THE CIRCUMSTANCES SURROUNDING AN EXPOSURE INCIDENT

• Engineering controls in use at the time • Work practices followed • Description of the device being used • Protective equipment or clothing used at the time of the exposure incident • Where the incident occurred • Procedure being performed when the incident occurred • Employee’s training

(4) TB training and education� Surveillance data from healthcare workers (HCWs) can protect both HCWs and patients� Screening can prevent future transmission by identifying lapses in infection control and expediting treatment for persons with latent TB infection (LTBI) or TB disease� Test for TB and document TB screening according to procedures in the 2005 CDC Guidelines� Maintain the protection of privacy and confidentiality of all test results�

All employees should receive baseline TB screening upon hire, using a two-step tuberculin skin test (TST) or a single blood assay Mycobacterium tuberculosis (BAMT) to test for infection� After baseline testing, do not conduct additional screening if an exposure to TB occurs� Individuals with a baseline positive or newly positive test result for TB or documentation of treatment for LTBI or TB disease should receive one chest radiograph result to exclude TB disease or provide an interpretable copy within a reasonable time frame, such as six months� Do not repeat radiographs unless symptoms or signs of TB disease develop or as recommended by a clinician�

All healthcare personnel should receive baseline TB screening upon hire, using two-step TST or a single BAMT to test for infection� After baseline testing, personnel should receive TB screening annually� Personnel with a baseline positive or newly positive test result or documentation of previous treatment for LTBI or TB disease should receive one chest radiograph result to exclude TB disease� Instead of participating in serial testing, personnel should receive a symptom screen annually� This screen should be accomplished by educating the employees about symptoms of TB disease and instructing them to report any such symptoms immediately� Treatment for LTBI should be in accordance with CDC guidelines�

Perform testing for TB infection every eight to ten weeks until lapses in infection control are corrected and no additional evidence of ongoing transmission exists� Consider the classification of potential ongoing transmission as a temporary classification only� It warrants immediate investigation and

BOX 7.10 TB TRAINING AND EDUCATION TOPICS

• Basic concepts of transmission, pathogenesis, and diagnosis • Explanation of the difference between latent and active tuberculosis • Signs and symptoms of active tuberculosis • Increased risk for those infected with HIV • Potential for occupational exposure • Information about prevalence of tuberculosis in the community • Situations that increase the risk of exposure • Principles of infection control • Importance of skin testing and significance of a positive test • Principles of preventive therapy for latent tuberculosis • Drug therapy procedures for active tuberculosis • Importance of notifying the facility • Information about medical evaluation for symptoms of active tuberculosis

corrective steps� After a determination that the ongoing transmission has ceased, reclassify the setting as medium risk� Recommend maintaining the classification of medium risk for at least one year�

These guidelines address patient and healthcare staff testing, source control methods, decontamination techniques, and prevention of tuberculosis-contaminated air� This enforcement policy refers to CDC guidelines and the OSHA general-duty clause� OSHA conducts inspections in response to complaints and during routine compliance visits in the following workplaces:

• Healthcare settings • Correctional institutions • Homeless shelters • Long-term care facilities • Drug treatment centers

1. OSHA Citations for TB Exposures OSHA can issue citations to employers as a result of exposure or potential exposure to the exhaled air of a suspected or confirmed case of tuberculosis� Exposure can occur during a high-hazard procedure performed on an individual with suspected or confirmed tuberculosis� OSHA can issue citations under the respirator standard (29 CFR 1910�134) when employers fail to provide respirators and fit testing to potentially exposed employees�

2. OSHA Abatement Methods Strive to identify persons with active tuberculosis� Provide medical surveillance at no cost to the employee, including pre-placement evaluation, tuberculosis skin tests, annual evaluations, and twice yearly exams for those exposed� Evaluate and manage individuals with a positive skin test� Use acid-fast bacilli isolation rooms for those with active or suspected TB infection� Maintain such rooms under negative pressure and use outside exhaust or high efficiency particulate air (HEPA)- filtered ventilation� Develop an employee information and training plan�

3. OSHA Tuberculosis Respirator Requirements OSHA requires healthcare organizations to meet the provisions of 29 CFR 1910�134, which covers respiratory protection for general industry� OSHA enforces all provisions, including annual fit testing, with regard to TB exposures� When using disposable respirators, never permit reuse unless maintaining the functional and structural integrity of the respirator� Maintaining functionality depends on adherence to the manufacturer’s instructions� Facilities should address the conditions under which a disposable respirator is considered contaminated� Whenever using reusable or disposable respirators, employers must implement a respiratory protection plan to meet the requirements of 29 CFR 1910�134� This entails creating a written respiratory protection plan for managing respirator selection and use, employee instruction and training, surveillance of work area conditions, and respirator fit testing� 29 CFR 1910�134 provides specific guidance on appropriate fit testing procedures� CDC guidelines, NIOSH recommendations, and selection criteria in the OSHA standard indicate that most facilities should use half-mask, N95, air purifying, filtering face piece respirators for TB protection� This type of respirator contains a securely fitting face piece� Effective protection requires a good seal between the face and the face piece to ensure individual protection� The OSHA Respiratory Protection standard does not require annual medical evaluations� However, employers must conduct annual fit tests for all respirator users� Never consider respirator fit testing as a hazard-specific or industry-specific activity� Annual fit testing provides the opportunity for employees to receive feedback on how well they don their respirator� Employees should receive fit testing annually as part of training�

Every healthcare setting should implement a TB infection control plan as a part of their overall infection control and prevention efforts� The specific details of the TB infection control plan can differ depending on patients encountered� Administrators making this distinction should obtain medical and epidemiologic consultation from state and local health departments� The TB infectioncontrol plan should consist of administrative controls, environmental controls, and a respiratoryprotection plan� Every setting providing services to persons with suspected or confirmed infectious TB disease, including laboratories and nontraditional facility-based settings, should develop a TB infection control plan� Take the following steps to establish a TB exposure-control plan: (1) assign supervisory responsibility for the TB infection-control plan to a qualified person or group; (2) delegate authority to conduct a TB risk assessment and implement and enforce TB infection-control policies; (3) ensure the completion of education and training; (4) develop a written TB exposure control plan that outlines control procedures; and (5) update the plan annually� Employers must develop procedures for evaluating suspected or confirmed TB disease when not promptly recognized or appropriate precautions or controls fail� Collaborate with the local or state health department to develop administrative controls consisting of the risk assessment, the written TB infection-control plan, management of patients with suspected or confirmed TB disease, training and education, screening and evaluation, problem evaluation, and coordination� Create a plan for accepting patients with suspected or confirmed TB disease when transferred from another setting�

1. Administrative Controls The first and most important level of TB controls is the use of administrative measures to reduce the risk for exposure to persons with TB disease� Administrative controls consist of the following activities: (1) assigning responsibility for TB exposure control in the setting, (2) conducting a TB risk assessment of the setting, (3) developing and instituting a written TB exposure control plan to ensure prompt detection, (4) use of airborne precautions, (5) treatment of persons with suspected or confirmed TB disease, and (6) ensuring the timely availability of recommended laboratory processing, testing, and reporting of results to the ordering physician and infection-control team� Other administration controls include implementing effective work practices for the management of patients with suspected or confirmed TB disease and ensuring proper cleaning and sterilization or disinfection of potentially contaminated equipment such as endoscopes� Provide training and education with specific focus on prevention, transmission, and symptoms� Conducting screening and evaluation of those at risk for TB disease remains a key administrative action�

2. Environmental Controls Environmental controls provide the second line of defense in the TB infection-control plan, after administrative controls� Environmental controls include technologies for the removal or inactivation of airborne TB� These technologies include local exhaust ventilation, general ventilation, HEPA filtration, and ultraviolet germicidal irradiation (UVGI)� These controls help to prevent the spread and reduce the concentration of infectious droplet nuclei in the air� CDC provides a summary of environmental controls and their use in prevention in the 2005 CDC TB Guidelines� Primary environmental controls consist of controlling the source of infection by using local exhaust ventilation (hoods, tents, or booths) and diluting and removing contaminated air by using general ventilation� Secondary environmental controls consist of controlling the airflow to prevent contamination of air in areas adjacent to the source (airborne infection isolation [AII] rooms) and cleaning the air by using HEPA filtration or UVGI�

3. Respiratory-Protection Controls The first two control levels minimize the number of areas in which exposure to M� tuberculosis might occur and, therefore, minimize the number of persons exposed� These control levels also reduce, but do not eliminate, the risk for exposure in the limited areas in which exposure can still occur�

Because persons entering these areas might be exposed to M� tuberculosis, the third level of the hierarchy is the use of respiratory protective equipment in situations that pose a high risk for exposure� Use of respiratory protection can further reduce risk for exposure from droplet nuclei expelled into the air from a patient with infectious TB disease� Take the following measures to reduce the risk of exposure: (1) implement a respiratory-protection plan, (2) train employees on respiratory protection, and (3) educate patients about respiratory hygiene and cough etiquette procedures�

4. Engineering Controls Engineering controls prove critical in preventing the spread of tuberculosis within a facility� The CDC guidelines recommend exhausting air from possibly infected areas to the outside� Healthcare facilities can develop isolation rooms with negative pressure� Recommend a rate of six air changes per hour� New construction requires 12 air changes per hour� Some facilities use UVGI to supplement ventilation and isolation efforts�

Once classified as a member of the plant kingdom, we now classify bacteria as a totally separate kingdom� Bacteria adapt remarkably and survive in diverse environmental conditions� They exist in the bodies of all living organisms and in all parts of the world, even in hot springs and the stratosphere� Bacteria normally exhibit one of three typical shapes: (1) rod shaped (bacillus), (2) round (cocci), and (3) spiral (spirillum)� An additional group (vibrios) appears as incomplete spirals� We can characterize bacteria by growth patterns such as the chains formed by streptococci� Bacillus and spirillum exhibit motile or swimming motions similar to the whip-like movements of flagella� Other bacteria possess rod-like appearances (called pili) that serve as tethers� Aerobic forms of bacteria function only in the presence of free or atmospheric oxygen� Anaerobic bacteria cannot grow in the presence of free oxygen but obtain oxygen from other compounds� Bacteria do not make their own food and must live in the presence of other plant or life� Bacteria grow when they find food and favorable conditions� A cough or sneeze releases millions of bacteria from the body�

Staphylococcus aureus can live on the skin or in the nose of healthy people� During the past 50 years, these infections became resistant to various antibiotics, including penicillin-related antibiotics� Infection control personnel refer to these resistant bacteria as methicillin-resistant MRSA� Colonization can occur when the staph bacteria survive on or in the body without causing illness� Staph bacteria causes a variety of illnesses, including skin infections, bone infections, pneumonia, and severe bloodstream infections� MRSA occurs more commonly among persons in hospitals and healthcare facilities� The infection usually develops in elderly hospitalized patients with serious illnesses or in an open wound such as a bedsore� Factors that place some patients at risk include long hospital stays, receiving broad-spectrum antibiotics, and being kept in an intensive care or burn unit� Keep cuts and abrasions clean and covered with a proper dressing or bandages and avoid contact with wounds or material contaminated by wounds� Implement contact precautions when identifying MRSA and the Infection Control and Prevention Function believes that a special clinical or epidemiological significance exists�

Smaller than bacteria, viruses contain a chemical compound with protein� They must infect a host to survive for long periods� Viruses depend on the host cells to reproduce� Outside of a host cell, a

virus exists as a protein coat or capsid that can enclose within a membrane� While outside the cell, a virus remains metabolically inert� A virus can insert genetic material to take over the functions of the host� An infected cell begins to produce more viral protein and genetic material instead of its usual products�

Some viruses may remain dormant inside host cells for long periods and cause no obvious change in the host cells� When stimulated, a dormant virus enters a phase that results in new viruses bursting and infecting other cells� Viruses cause a number of diseases, including smallpox, colds, chickenpox, influenza, shingles, hepatitis, polio, rabies, and AIDS� Disinfectants destroy viruses very easily�

The mold spore produced by Aspergillus can create pathogenic infection opportunities� Aspergillus exists worldwide and can thrive at elevated temperatures� Ideal growth conditions include damp areas with decaying vegetation� Aspergillus appears initially as a flat thread-like white growth that soon becomes a powdery blue-green mold spore� Most infections result from inhaling these spores� Most people possess natural immunity and do not develop any disease� Patients with serious ailments tend to experience a greater risk of infection� The severity of Aspergillus depends on the individual’s immune system� Aspergillus infection can range from sinusitis conditions to pulmonary infections, including pneumonia� Ventilation plays a key role in maintaining an Aspergillus-free environment in healthcare settings� Establish procedures to control dust during renovations that occur near patient areas�

Exposure to this spore-forming bacterium results in black, coal-like skin lesions� In the naturally occurring forms, anthrax passes on by contact with anthrax-infected or anthrax-contaminated animals and animal products� Anthrax does not spread from one person to another person� Humans can host three forms of anthrax: inhalation, cutaneous, and gastrointestinal� Inhalation anthrax occurs when the anthrax spore is inhaled� Cutaneous anthrax, the most common naturally occurring form, is contracted by handling contaminated hair, wool, hides, flesh, blood, or excreta of infected animals and from manufactured products such as bone meal� It is introduced through scratches or abrasions of the skin� Gastrointestinal anthrax occurs as a result of ingesting insufficiently cooked infected meat or from flies� The spores enter the lungs, migrate to the lymph nodes, change to the bacterial form, multiply, and produce toxins�

Severe Acute Respiratory Syndrome (SARS) is an emerging, sometimes fatal, respiratory illness� The first identified cases occurred in China in 2002� Some experts believe a virus causes SARS; however, the specific agent remains unidentified� No laboratory or other test can definitively identify cases� Most suspected SARS cases occurring in the United States involve individuals returning from travel to Asia and healthcare staff members in contact with patients� Casual contact does not appear to cause SARS� Transmission appears to occur primarily through close contact with a symptomatic patient� Signs of illness include a decreased white blood cell count in most patients as well as below-normal blood platelet counts, increased liver enzymes, and electrolyte disturbances in a number of patients�

Pseudomonas, a motile rod-shaped organism, uses glucose in an oxidative manner� These bacteria pose a clinically important risk because of their resistance to most antibiotics� They can survive

conditions that few other organisms can tolerate, aided by their production of a protective slime layer� The key targets include immune-suppressed individuals, burn victims, and individuals on respirators or with indwelling catheters� Additionally, these pathogens colonize the lungs of cystic fibrosis patients, increasing the mortality rate of individuals with the disease� Infections can occur at many sites and can lead to urinary tract infections, sepsis, pneumonia, and pharyngitis�

Rarely does Pseudomonas cause infection in healthy individuals� Its noninvasive nature limits its pathogenic capabilities� Pseudomonas prefers to inhabit moist environments but it can survive in a medium as deficient as distilled water�

Studies link a majority of outbreaks of Legionella to cooling towers and domestic water systems� Other sources include evaporative condensers, respiratory equipment, showers, faucets, whirlpool baths, humidifiers, and decorative fountains� Hot-water systems provide a perfect breeding habitat, as Legionella grows best in temperatures ranging from 95 to 115 degrees Fahrenheit� Uncontrollable incidents that can cause Legionella problems include surges in water pressure that may disperse dirt into the water system or dislodge Legionella-laden scale and sediment from the walls of water pipes� Legionella can enter cooling towers, air intakes, or water pipes� In addition, new or renovated water lines not properly flushed prior to opening may contain Legionella� Idle plumbing can hold heavy contamination due to stagnant water� Current human treatment includes the antibiotics erythromycin and rifampin for severe cases�

Infection Control Risk Assessment (ICRA) functions best as a multidisciplinary process that focuses on reducing risk from infection throughout facility planning, design, construction, and renovation activities� A multidisciplinary team considers environment, infectious agents, human factors, and impact of a proposed project on controlling infections� The team includes, at a minimum, experts in infectious disease, infection control, patient care, epidemiology, facility design, engineering, construction, and safety, as circumstances dictate�

Educate both the construction team and healthcare staff about high-risk patient areas with regard to the airborne infection risks associated with construction projects, dispersal of fungal spores during such activities, and methods to control the dissemination of fungal spores� Incorporate mandatory adherence agreements for infection control into construction contracts, with penalties for noncompliance and mechanisms to ensure timely correction of problems� Establish and maintain surveillance for airborne environmental disease such as Aspergillus during construction, renovation, repair, and demolition activities to ensure the health and safety of high-risk patients�

Medical waste is defined in 40 CFR 259�10 and 40 CFR 22 as any solid waste generated in the diagnosis, treatment, or immunization of human beings or animals, in related research, biological production, or testing� Currently medical waste is regulated by most states� Segregate infectious waste from other waste at the point of generation within the facility� Ensure packaging contains the infectious waste from the point of generation up to the point of proper treatment or disposal� Place contaminated sharps immediately in rigid, leak-proof, puncture-resistant containers� Conspicuously identify all containers used for disposal of infectious waste� Handle and transport infectious waste to maintain integrity of the packaging� Do not transport plastic bags containing infectious waste using chutes or dumbwaiters� Establish procedures for storing infectious waste that would inhibit rapid microbial growth and minimize exposure potential� Isolate the area after a spill, discovery of ruptured packaging, or other incident involving potentially infectious materials� When practicable,

repackage all spilled waste and containment debris� Disinfect all containment equipment and surfaces appropriately� Complete the appropriate incident report�

Regulated medical waste, a subset of all medical wastes, includes several categories, which can vary depending on the state or locality�

Red or clear biohazard sharps containers can also contain regulated medical or infectious waste, but will more specifically hold items that could potentially puncture the skin and transmit an infectious disease� Needles and syringes make up the first type of sharps people correlate with sharps containers� Other items can become sharps hazards including pipettes, scalpels, and lancets� Contents can consist of used or unused sharps that could potentially contain pourable, squeezable, or dried flaky blood� Since the primary components placed in sharps containers include needles and syringes, sharps containers in some states may require incineration to prevent misuse of these items�

Medical facilities and pharmaceutical companies bear the enormous task of segregating and disposing of the wastes that accumulate during the development of medicines and treatment of patients� These wastes pose very different hazards and impacts on the environment and human beings�

Many types of containers can assist with proper segregation of wastes� Proper training on the use of containers protects the environment and humans but also reduces disposal costs by identifying what should and should not go into specified containers� Use red biohazard bags only for Regulated Medical Waste consisting of solid, liquid, or semi-liquid blood, or other potentially infectious material and contaminated items that, if compressed, could release blood or infectious material during normal handling� This includes waste generated during the treatment or diagnosis of humans or animals or in the testing of biologicals� Common contents could include empty IV bags and tubing, gloves, gowns, or other materials containing pourable, squeezable, flaking, or dripping blood, including bodily fluids� Use red bags or bags clearly identified with the international biohazard symbols to contain materials requiring disinfection� Rendering materials noninfectious could permit disposal in a nonhazardous landfill� When red bag waste requires incineration, send the materials to a Regulated Medical Waste Incinerator permitted by the EPA� Consider incineration for all pathological waste�

Blood and body fluids include bulk laboratory specimens of blood tissue, semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, and amniotic fluid� Precautions do not apply to feces, nasal secretions, sputum, sweat, tears, urine, or vomit unless

BOX 7.11 SOME CATEGORIES OF REGULATED BIOMEDICAL WASTES

• Cultures and stocks of infectious agents • Human pathological wastes such as tissues and body parts • Human blood and blood products • Sharps (needles and syringes used in care areas) • Certain animal wastes • Certain isolation wastes (e�g�, wastes from patients with highly communicable

diseases) • Unused sharps (suture needles, scalpel blades, hypodermic needles)

they contain visible blood� Handle free-flowing materials or items saturated to the point of dripping liquids containing visible blood or blood components� Pathological waste includes all discarded waste from renal dialysis contaminated with peritoneal fluid or blood visible to the human eye� Consider solid renal dialysis waste as medical waste if it is saturated and demonstrates the potential to drip/splash blood or other regulated body fluids� Waste sharps include any used or unused discarded article that may cause punctures or cuts�

Provide medical waste spill response and cleanup training� Educate staff on how to properly identify all nonregulated waste and dispose of it� Inform local regulators and involve them in the effort to reduce waste and properly regulate medical waste� Establish and post guides for identifying regulated medical waste at every site of generation and disposal� Weigh each container, log them, and compare totals from each generator; retrain departments with high utilization� Provide PPE to facilitate alternative disposal methods� Date sharps containers when first used and remove only when 75 percent full or when meeting an established time limit of use� Place medical waste receptacles in such a way as to avoid indiscriminate use�

The outermost layer of packaging for medical containers, excluding sharps, should be of a red background color or use red lettering with a contrasting color� Clearly label the container with warnings such as “Infectious Waste,” “Medical Wastes,” or “Biohazardous�” The container should also bear the universal biohazard symbol� Print wording on the container or securely attach a label on two or more sides� Ensure the symbol measures at least six inches in diameter and contains print with a contrasting color to the background� Ensure the use of impermeable containers of sufficient strength to resist ripping, tearing, or bursting under normal conditions of use� Place sharps in rigid, leak-proof, puncture-resistant, sealed containers to prevent loss during handling� Clearly label all containers� Place small containers used to collect untreated medical waste inside larger containers during storage, transportation, and disposal activities�

During collection, storage, and transportation, use containers constructed of materials compatible with the treatment methods utilized� Ensure the use of burnable single-use containers for waste destined for incinerators� Containers destined for steam sterilizers should allow proper treatment of the waste� Decontaminate reusable containers after each use using only approved methods� Never reuse containers unless decontaminated and before use remove all medical waste labeling�

The EPA promulgated new source performance standards and emission guidelines in 1997� Refer to 40 CFR 60, Subparts E and C, for standards on new and existing incinerators� Existing sources include those for which construction was commenced on or before June 20, 1996� Hospitals, clinics, and clinical research laboratories operating a medical incinerator must comply with the New Source Performance Standards (NSPS) as defined in 40 CFR 60, Subpart C� Steam sterilization uses saturated steam within a pressure vessel at temperatures high enough to kill infectious agents� Steam sterilization works effectively with low-density materials such as plastics� Containers effectively treated can include plastic bags, metal pans, bottles, and flasks�

Never sterilize materials with high-density polyethylene and polypropylene because they do not allow steam penetration� Refer to 40 CFR 60�51 for classification information on waste streams such as hospital waste, medical and infectious waste, and pathological waste� Consider other methods such as (1) shredding or compacting with steam autoclaving, (2) microwave irradiation, (3) thermal treatment, and (4) chemical/biological treatment� Discharge into the sewer system suctioned fluids, waste in liquid apparatus, bodily discharges, and dialysis waste� Sterilize substances such as cultures, etiologic agents, and other laboratory wastes� Use chemical disinfection methods in dialysis equipment and for specimen spills prior to cleaning� Never use compactors or grinders to process infectious wastes� When shipping waste offsite, collect, transport, and store in a manner prescribed by the contractor� Require contractors to only pick up wastes in leak-proof and fully enclosed containers� Require contractors to maintain all required permits relevant to medical waste disposal� Contractors must also maintain regulatory documentation and records relevant to disposal actions including incinerated waste�

The Pipeline and Hazardous Materials Safety Administration (PHMSA) develops and issues hazardous materials regulations (49 CFR 100-180)� The regulations govern the classification, hazard communication, and packaging of hazardous materials for transportation� The DOT classified infectious substances, including regulated medical waste, in Division 6�2 of the hazardous materials rules� Shippers of infectious substances must meet all standards related to commerce by rail, water, air, or highway� Regulated Medical Waste Packaging (49 CFR 173�197) must meet certain requirements� Ensure the use of rigid, leak-resistant, impervious to moisture, and strong packing materials to prevent tearing or bursting under normal conditions of use and handling� Properly seal all waste containers to prevent leakage during transport� Ensure the use of puncture-resistant sharps containers� Ship waste materials in break-resistant containers, tightly lidded, or stopper closed for fluids� Package and mark with the “Biohazard” marking in accordance with OSHA standard, 29 CFR 1910�1030� Diagnostic specimens and biological products do not qualify for regulation except when transported as regulated medical waste� An infectious substance consists of a viable microorganism, or its toxin, that causes or may cause disease in humans or animals� Consider regulated medical waste as any waste or reusable material that contains an infectious substance and is generated in the diagnosis, treatment, or research of humans or animals� This definition does not include discarded cultures or stocks�

A biological product refers to any material prepared and manufactured in accordance with certain regulations of the Department of Agriculture or the Department of Health and Human Services� A diagnostic specimen refers to any human or animal material being shipped for purposes of diagnosis� It includes but is not limited to excreta, secreta, blood, blood components, tissue, and tissue fluids�

BOX 7.12 DOT TRAINING AND REPORTING REQUIREMENTS

• All hazardous material employees must be trained in accordance with 49 CFR 172 • Training must address general awareness, function-specific, and safety rules • Test each employee and maintain record of testing • Retrain hazardous materials employees every two years • Report any infectious substance spill to the CDC according to 49 CFR 171�15 • For other reportable hazardous material spills, contact the DOT National Response

Center

1� List at least seven infection control plan development considerations� 2� List the three healthcare vaccine categories� 3� Healthcare employees should meet the ACIP guidelines for immunization of which four

diseases? 4� The Guidelines for Environmental Infection Control in Healthcare Facilities would not

apply to which three broad categories of biological risks? 5� List the six types of disease and infection transmission routes� 6� What three diseases or pathogens can transmit by airborne routes in healthcare facilities? 7� List three hospital-acquired conditions that could qualify for potential reduced payments� 8� List the three types of chemical germicides� 9� Which federal agency regulates liquid chemical sterilants and high-level disinfectants? 10� Describe in your own words the three CDC-defined disinfecting levels� 11� What three types of information does OSHA require on sharps injury logs? 12� Describe the CDC-recommended TB screening procedures for settings classified as low

risk� 13� Describe the process known as an ICRA�