Section: G Policy Number: 10 Section Title: Health Center Clinical Scope: Clinical Protocols Policy Title: Infection Control and Prevention of Transmission Policy Date Approved by Board of Directors: xx/xx/xxxx 1. Summary Within the health-care setting, general infection control procedures have been developed to minimize the risk of patient acquisition of infection from contact with contaminated devices, objects, or surfaces &/or of transmission of an infectious agent from health-care workers to patients. Such procedures also protect workers from the risk of becoming infected. General infection-control procedures are designed to prevent transmission of a wide range of microbiological agents and to provide a wide margin of safety in the varied situations encountered in the health-care environment. La Comunidad Hispana (LCH) will implement this infection control policy across the environment of care as a general practice, and including specific controls wherever and whenever healthcare workers and/or clients are deemed to be at risk. 2. Key Standards 2.1 Universal precautions Universal Precautions (UP) are intended to prevent parenteral, mucous membrane, and nonintact skin exposures of health-care workers to bloodborne pathogens. In addition to emphasizing prevention of needlestick injuries and the use of traditional barriers such as gloves and gowns, UP expanded Blood and Body Fluid Precautions to include use of masks and eye coverings to prevent mucous membrane exposures during certain procedures and the use of individual ventilation devices when the need for resuscitation was predictable. 2.1.1 Body fluids to which universal precautions apply Universal precautions apply to blood and to other body fluids containing visible blood. Occupational transmission of HIV and HBV to health-care workers by blood is documented. Universal precautions also apply to semen and vaginal secretions. Although both of these fluids have been implicated in the sexual transmission of HIV and HBV, they have not been implicated in occupational transmission from patient to health-care worker. 1 2.1.2 Body fluids to which universal precautions do not apply: Precautions do not apply to feces, nasal secretions, sputum, sweat, tears, urine, and vomitus unless they contain visible blood. The risk of transmission of HIV and HBV from these fluids and materials is extremely low or nonexistent. Human breast milk has been implicated in perinatal transmission of HIV, and HBsAg has been found in the milk of mothers infected with HBV; however, occupational exposure to human breast milk has not been implicated in the transmission of HIV nor HBV infection to health-care workers. Universal precautions do not apply to saliva. General infection control practices already in existence, including the use of gloves for digital examination of mucous membranes and hand washing after exposure to saliva, should further minimize the minute risk, if any, for salivary transmission of HIV and HBV. 2.2 Standard precautions Standard Precautions synthesize the major features of Universal Precautions (designed to reduce the risk of transmission of bloodborne pathogens) and Body Substance Isolation (designed to reduce the risk of transmission of pathogens from moist body substances). Standard Precautions apply to a) blood; b) all body fluids, secretions, and excretions, except sweat, regardless of whether or not they contain visible blood; c) nonintact skin; d) mucous membranes. Standard precautions are designed to reduce the risk of transmission of microorganisms from both recognized and unrecognized sources of infection in health care settings. 2.3 Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) transmission Although the potential for HBV transmission in the workplace setting is greater than for HIV, the modes of transmission for these two viruses are similar. Both have been transmitted in occupational settings only by percutaneous inoculation or contact with an open wound, nonintact (e.g., chapped, abraded, weeping, or dermatitic) skin, or mucous membranes to blood, bloodcontaminated body fluids, or concentrated virus. Blood is the single most important source of HIV and HBV in the workplace setting. Protection measures against HIV and HBV for workers should focus primarily on preventing these types of exposures to blood as well as on delivery of HBV vaccination. The risk of infection with HIV following one needle-stick exposure to blood from a patient known to be infected with HIV is approximately 0.5%. This rate of transmission is considerably lower than that for HBV, probably as a result of the significantly lower concentrations of virus in the blood of HIV-infected persons. Though inadequately quantified, the risk from exposure of nonintact skin or mucous membranes is likely to be far less than that from percutaneous inoculation. 2.4 Transmission-based precautions Transmission-Based Precautions are designed for patients documented or suspected to be infected or colonized with highly transmissible or epidemiologically important pathogens for which additional precautions beyond Standard Precautions are needed to interrupt transmission 2 in hospitals. There are three types of Transmission-Based Precautions: Airborne Precautions, Droplet Precautions, and Contact Precautions. They may be combined for diseases that have multiple routes of transmission. When used either singularly or in combination, they are to be used in addition to Standard Precautions. (See attachment A) 2.4.1 Contact Precautions Contact, or touch, is the most common and most significant mode of transmission of infectious agents. Patients in Contact Precautions include those infected or colonized with Clostridium difficile ("C. diff"), rotavirus, or other organisms. Contact transmission can occur by directly touching the patient, through contact with the patient’s environment, or by using contaminated gloves or equipment. Patients with Contact Precautions require: • Private Room. • Dedicated, disposable equipment (e.g., stethoscope, blood pressure cuff, thermometer, etc.). • Shared equipment is to be cleaned with hospital disinfectant (e.g. disposable detergent disinfectant-impregnated wipes) after each use. • Alert staff to type of precautions being used. Healthcare workers caring for patients in Contact Precautions must: • Put on gloves before entering the room • Put on a disposable gown prior to entering the patient’s room when direct contact with the patient or the patient’s environment is anticipated. • Remove and discard gloves and gown and clean hands before leaving the patient’s room or, in semi-private room or multi-bed bay situation, before leaving the patient’s immediate vicinity. 2.4.2 Droplet Precautions Droplets are formed when a person coughs, sneezes, speaks, spits, sings, or undergoes oral or tracheal/bronchial suctioning. Transmission occurs when droplets containing microorganisms generated from an infected person are propelled a short distance (about 3 feet), and may come in contact with another person’s conjunctivae or mucous membranes (eyes, nose or mouth). Diseases transmitted by the droplet route include influenza, and meningococcal meningitis. Droplets do not remain suspended in the air, and are not transmitted by the airborne route. Caregivers must wear a mask that covers the mouth and nose (regular surgical or paper mask), and eye protection (safety goggles, fluid shield). Patients in Droplet Precautions require: • Private room, except when directed otherwise by Infection Control. • Alert staff to type of precautions being used Family A. Family will be educated regarding the transmission of droplet-borne diseases: • Hand hygiene with alcohol based hand rub or soap and water should be performed regularly and always upon leaving the patient’s room. 3 • Risk of acquisition of droplet-borne diseases is reduced through the use of personal protective equipment (i.e., surgical mask with eye shield or goggles). B. Nursing staff must instruct family/visitors to clean hands after contact with patient secretions or contact with immediate patient environment. 2.4.3 Airborne Precautions When a person infected with Tuberculosis, Measles, and Chicken Pox coughs, sneezes, speaks, spits, sings, or undergoes oral or tracheal/bronchial suctioning, droplet nuclei (particles sized 5 microns or smaller), which carry the infectious organism may be released into the air and be carried via air currents. Patients in Airborne Precautions require: • Private Negative Pressure Isolation Room (NPIR) in the event of confirmed active TB. IF no room is available, patient room will be left empty for 1 hour with door closed after patient is transferred to appropriate facility. • All persons entering the room of a patient with suspected or confirmed tuberculosis MUST wear an N-95 respirator mask. Healthcare workers or family members susceptible to chickenpox or measles MAY NOT enter the patient’s room; healthcare workers immune to chickenpox or measles may enter the room without wearing a mask. The varicella vaccination is NOT 100% effective in conferring immunity to chickenpox. Health care workers who have not had the disease but have been vaccinated shall refrain from entering the room of a patient with chickenpox or disseminated zoster when there are other immune caregivers available. • Confinement to their room except for essential purposes, in which case, a regular mask (surgical or paper) is worn by the patient at all times outside the negative pressure environment. (Patients with airborne transmitted diseases are not required to wear an N95 respirator.) • Alert staff to type of precautions being used Family members A. For patients with suspected or confirmed tuberculosis: Family members will wear a surgical mask that is secured and snugly fitted. 3. Employer Responsibilities 3.1 General This policy contains a detailed description of the procedures employees at LCH shall follow in order to protect themselves, staff, and clients from infection transmission in the workplace. LCH’s duties as an employer shall also contribute to an environment of safety designed for mitigation of infectious transmission of disease. 3.2 Classification of work activity. Employee activities are classified according to the standards set out in the Joint Advisory Work Classification (Appendix B). LCH employees engaged in Category I activities shall use the appropriate protective equipment. Personal protective equipment (PPE) shall be available to all workers when they engage in Category I or II activities. 4 a) LCH employees potentially involved in Category I activities as part of their scope of practice as defined in their job description include licensed and non-licensed personnel providing direct patient care. All health center staff may potentially be involved in Category II activities in the event of an emergency, and will also have PPE available to them. b) All LCH employees shall follow protocols and procedures related to their scope of practice and specific to the type of activity being performed. All employees shall undergo orientation and training to their job and scope of activities to be performed in their position. Ongoing training shall be performed and assessed annually. 3.3. Preventing transmission of Hepatitis B Virus to workers All workers whose jobs involve participation in tasks or activities with exposure to blood or other body fluids to which universal precautions apply (as defined above) should be vaccinated with hepatitis B vaccine. 3.5. Workers with immunosuppression Workers with impaired immune systems are at increased risk of acquiring or experiencing serious complications of infectious disease. Of particular concern is the risk of severe infection following exposure to other persons with infectious diseases that are easily transmitted if appropriate precautions are not taken (e.g., measles, varicella). Any worker with an impaired immune system should be counseled about the potential risk associated with providing health care to persons with any transmissible infection and should continue to follow existing recommendations for infection control to minimize risk of exposure to other infectious agents. The question of whether workers infected with HIV can adequately and safely be allowed to perform patient-care duties or whether their work assignments should be changed must be determined on an individual basis. These decisions should be made by the worker's personal physician(s) in conjunction with the employer's medical advisors. 4. Use of Protective Barriers and PPE Universal precautions are intended to supplement rather than replace recommendations for routine infection control, such as handwashing and using gloves to prevent gross microbial contamination of hands. All employees protective barriers to prevent exposure to blood, body fluids containing visible blood, and reduce the risk of exposure of the health-care worker's skin or mucous membranes to potentially infective materials. The type of protective barrier(s) should be appropriate for the procedure being performed and the type of exposure anticipated. Because specifying the types of barriers needed for every possible clinical situation is impractical, some judgment must be exercised. Examples of protective barriers include gloves, gowns, masks, and protective eyewear. 4.1 General risk reduction The risk of nosocomial transmission of HIV, HBV, and other bloodborne pathogens can be minimized if health-care workers use the following general guidelines: 5 a) Take care to prevent injuries when using needles, scalpels, and other sharp instruments or devices; when handling sharp instruments after procedures; when cleaning used instruments; and when disposing of used needles. b) Do not recap used needles by hand; do not remove used needles from disposable syringes by hand; and do not bend, break, or otherwise manipulate used needles by hand. c) Place used disposable syringes and needles, scalpel blades, and other sharp items in puncture-resistant containers for disposal. d) Locate the puncture-resistant containers as close to the use area as is practical. 4.2 Personal protective equipment Appropriate personal protective equipment should be made available routinely by LCH to reduce the risk of exposure as defined above. For many situations, the chance that the health center staff will be exposed to blood and other body fluids to which universal precautions apply can be determined in advance. If the chance of being exposed to blood is high, the worker should put on protective attire before beginning patient care. Appendix C sets forth examples of recommendations for personal protective equipment in clinical settings; the list is not intended to be all-inclusive. 4.2.1. Gloves Disposable gloves should be a standard component of clinic equipment, and should be donned by all personnel prior to initiating any emergency patient care tasks involving exposure to blood or other body fluids to which universal precautions apply. Gloves should reduce the incidence of contamination of hands, but they cannot prevent penetrating injuries due to needles or other sharp instruments. Extra pairs should always be available. Considerations in the choice of disposable gloves should include dexterity, durability, fit, and the task being performed. Thus, there is no single type or thickness of glove appropriate for protection in all situations. For situations where large amounts of blood are likely to be encountered, it is important that gloves fit tightly at the wrist to prevent blood contamination of hands around the cuff. While wearing gloves, avoid handling personal items, such as combs and pens, that could become soiled or contaminated. Gloves that have become contaminated with blood or other body fluids to which universal precautions apply should be removed as soon as possible, taking care to avoid skin contact with the exterior surface. Contaminated gloves should be placed in bags that prevent leakage and should be disposed of or, in the case of reusable gloves, cleaned and disinfected properly. While wearing gloves, clinicians should observe “clean technique” standards. The following general guidelines for glove use are recommended: a) Use sterile gloves for procedures involving contact with normally sterile areas of the body. 6 b) Use examination gloves for procedures involving contact with mucous membranes, unless otherwise indicated, and for other patient care or diagnostic procedures that do not require the use of sterile gloves. c) Change gloves between patient contacts. d) Do not wash or disinfect surgical or examination gloves for reuse. Washing with surfactants may cause "wicking," i.e., the enhanced penetration of liquids through undetected holes in the glove. Disinfecting agents may cause deterioration. e) Use general-purpose utility gloves (e.g., rubber household gloves) for housekeeping chores involving potential blood contact and for instrument cleaning and decontamination procedures. Utility gloves may be decontaminated and reused but should be discarded if they are peeling, cracked, or discolored, or if they have punctures, tears, or other evidence of deterioration. 4.2.2. Glove use for phlebotomy Follow the guidelines in section 4.2.1. The likelihood of hand contamination with blood containing HIV, HBV, or other bloodborne pathogens during phlebotomy depends on several factors: a) the skill and technique of the health-care worker, b) the frequency with which the health-care worker performs the procedure (other factors being equal, the cumulative risk of blood exposure is higher for a health-care worker who performs more procedures), c) whether the procedure occurs in a routine or emergency situation (where blood contact may be more likely), d) the prevalence of infection with bloodborne pathogens in the patient population. 4.2.3 Gowns, and other protective clothing As per the Occupational Safety and Health Act, masks, gowns, aprons, lab coats, clinic jackets or similar outer garments shall be worn and used in accordance with the level of exposure encountered. Management of the patient who is not bleeding, and who has no bloody body fluids present, should not routinely require use of barrier precautions. Protective clothing should be worn to protect clothing from splashes with blood and/or other body fluids. If large splashes or quantities of blood and/or other body fluids are present or anticipated, impervious gowns or aprons should be worn. 4.2.4 Masks, eye protection and face shields Masks and protective eyewear or face shields should reduce the incidence of contamination of mucous membranes of the mouth, nose, and eyes. As per the Occupational Safety and Health Act, masks and eyewear (e.g., safety glasses), and/or face shields should be worn whenever splashes, sprays, or droplets of blood or other infectious 7 material may be generated and eye, nose, or mouth contamination can be reasonably anticipated. 4.2.5 Resuscitation equipment No transmission of HBV or HIV infection during mouth-to-mouth resuscitation has been documented. However, because of the risk of salivary transmission of other infectious diseases (e.g., herpes simplex and Neisseria meningitidis) and the theoretical risk of HIV and HBV transmission during artificial ventilation of trauma victims, disposable airway equipment or resuscitation bags should be used. Disposable resuscitation equipment and devices should be used once and disposed of or, if reusable, thoroughly cleaned and disinfected after each use according to the manufacturer's recommendations. 5. Disinfection, Decontamination, and Disposal The CDC precaution guidelines described below should be routinely followed. 5.1. Needle and sharps disposal All workers should take precautions to prevent injuries caused by needles, scalpel blades, and other sharp instruments or devices during procedures; when cleaning used instruments; during disposal of used needles; and when handling sharp instruments after procedures. 5.1.1 To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand, removed from disposable syringes, or otherwise manipulated by hand. 5.1.2 After they are used, disposable syringes and needles, scalpel blades, and other sharp items should be placed in puncture-resistant containers for disposal. 5.1.3 The puncture-resistant containers should be located as close as practical to the use area. 5.1.4 Reusable needles should be left on the syringe body and should be placed in a puncture-resistant container for transport to the reprocessing area. 5.2. Hand washing Hands and other skin surfaces should be washed immediately and thoroughly if contaminated with blood, other body fluids to which universal precautions apply, or potentially contaminated articles. Hands should always be washed after gloves are removed, even if the gloves appear to be intact. Hand washing should be completed using the appropriate facilities, such as utility or restroom sinks. Waterless antiseptic hand cleanser should be provided to use when hand-washing facilities are not available. When hand-washing facilities are available, wash hands with warm water and soap. The manufacturer's recommendations for the product should be followed. 5.3. Cleaning and decontaminating spills of blood 8 All spills of blood and blood-contaminated fluids should be promptly cleaned up using an EPAapproved germicide or a 1:100 solution of household bleach in the following manner while wearing gloves. Visible material should first be removed with disposable towels or other appropriate means that will ensure against direct contact with blood. If splashing is anticipated, protective eyewear should be worn along with an impervious gown or apron that provides an effective barrier to splashes. The area should then be decontaminated with an appropriate germicide. Hands should be washed following removal of gloves. Soiled cleaning equipment should be cleaned and decontaminated or placed in an appropriate container and disposed of. 5.4. Decontamination and laundering of protective clothing Protective work clothing contaminated with blood or other body fluids to which universal precautions apply should be placed and transported in bags or containers that prevent leakage. Personnel involved in the bagging, transport, and laundering of contaminated clothing should wear gloves. Protective clothing and work uniforms should be washed and dried according to the manufacturer's instructions. Boots and leather goods may be brush-scrubbed with soap and hot water to remove contamination. 6. Hazardous Waste Disposal LCH contracts for biohazardous waste disposal. The following guidelines shall be followed in disposal of infectious waste. 6.1 General infectious waste disposal The relative risk of disease transmission and application of local regulations, which vary widely, determine the selection of procedures for disposal of infectious waste. In all cases, local regulations should be consulted prior to developing disposal procedures and followed. Infectious waste should either be incinerated or should be decontaminated before disposal in a sanitary landfill. Bulk blood, suctioned fluids, excretions, and secretions may be carefully poured down a drain connected to a sanitary sewer, where permitted. Sanitary sewers may also be used to dispose of other infectious wastes capable of being ground and flushed into the sewer, where permitted. Sharp items should be placed in puncture-proof containers and other bloodcontaminated items should be placed in leak-proof plastic bags for transport to an appropriate disposal location. 6.2 Infectious waste categories Clinic wastes can be categorized as infectious or noninfectious. 6.2.1 Infectious wastes include human, animal, or biological wastes and any items that may be contaminated with pathogens. 6.2.2 Noninfectious wastes include toxic chemicals, cytotoxic drugs, and radioactive, flammable, and explosive wastes. 6.3 Specific types of infectious waste Infectious wastes classifications common in health centers: 9 6.4 6.3.1 Cultures and stocks of infectious agents and associated biologicals include specimen cultures from medical and pathological laboratories, cultures and stocks of infectious agents from research and industrial laboratories, wastes from the production of biologicals, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate, and mix cultures. 6.3.2 Human blood and blood products include blood as well as serum, plasma, and other blood products. 6.3.3 Pathological wastes include tissues and body fluids that are removed during surgical procedures. 6.3.4 Contaminated sharps such as hypodermic needles syringes, Pasteur pipettes, broken glass, and scalpel blades. These items should be considered infectious wastes because of the possibility of contamination with blood-borne pathogens. 6.3.5 Miscellaneous wastes that are not designated as infectious should be assumed to be infectious and should be managed as such to maintain consistent levels of protection for both the environment and for persons handling these wastes. Miscellaneous wastes include those from contaminated laboratory wastes, and contaminated equipment. 6.3.6 Wastes from surgery include soiled dressings, sponges, drapes, lavage tubes, drainage sets, underpads, and surgical gloves. 6.3.7 Contaminated laboratory wastes include specimen containers, slides and cover slips, disposable gloves, laboratory coats, and aprons. 6.3.8 Contaminated equipment refers to discarded equipment and parts that are used in patient care, medical and industrial laboratories, research, and the production and testing of certain pharmaceuticals. Treatment and disposal methods 6.4.1 Several methods are used for infectious waste treatment, depending on the type of waste material. These treatment methods include steam sterilization, incineration, thermal inactivation, gas/vapor sterilization, chemical disinfection, and sterilization by irradiation. (See Appendix D). In utilizing any treatment and disposal method, follow the manufacture instructions for use of equipment. Important Note: To assure the effectiveness of any sterilization or disinfection process, equipment and instruments must first be thoroughly cleaned of all visible soil. 7. Guidelines for the Management of Health-Care Worker (HCW) Exposures to HIV and HBV. 10 As covered in the 1998 CDC publication Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis MMWR 47, “health-care organizations must have a system that includes written protocols for prompt reporting, evaluation, counseling, treatment, and follow-up of occupational exposures that may place HCWs at risk for acquiring any bloodborne infection, including HIV.” The following section outlines the content of the required protocol. 7.1 Exposure report for HIV If an occupational exposure occurs, the circumstances and post exposure management shall be recorded in the HCW's confidential medical record and on an OSHA 300 form for occupational exposure. HCWs should be educated to report occupational exposures immediately after they occur, particularly because post exposure prophlaxis is most likely to be effective if implemented as soon after the exposure as possible. Relevant information includes: a) date and time of exposure; b) details of the procedure being performed, including where and how the exposure occurred, and if the exposure was related to a sharp device, the type of device and how and when in the course of handling the device the exposure occurred; c) details of the exposure, including the type and amount of fluid or material and the severity of the exposure (e.g., for a percutaneous exposure, depth of injury and whether fluid was injected; or for a skin or mucous-membrane exposure, the estimated volume of material and duration of contact and the condition of the skin {e.g., chapped, abraded, or intact}); d) details about the exposure source (i.e., whether the source material contained HIV or other bloodborne pathogen{s}), and if the source is an HIV-infected person, the stage of disease, history of antiretroviral therapy, and viral load, if known; and e) 7.2 details about counseling, post exposure management, and follow-up. Exposure management for HIV (See Appendix E) 7.2.1 Treatment of an Exposure Site Wounds and skin sites that have been in contact with blood or body fluids should be washed with soap and water; mucous membranes should be flushed with water. 7.2.2 Assessment of Infection Risk After an occupational exposure, the source-person and the exposed HCW should be evaluated to determine the need for HIV PEP. Follow-up for hepatitis B virus and hepatitis C virus infections also should be conducted in accordance with previously published CDC recommendations. 11 7.2.3 Evaluation of exposure. The exposure should be evaluated for potential to transmit HIV based on the type of body substance involved and the route and severity of the exposure. Exposures to blood, fluid containing visible blood, or other potentially infectious fluid (including semen; vaginal secretions) or tissue through a percutaneous injury (i.e., needlestick or other penetrating sharps-related event) or through contact with a mucous membrane are situations that pose a risk for bloodborne transmission and require further evaluation. (See Table 2) 7.2.4 Evaluation and testing of an exposure source. The person whose blood or body fluids are the source of an occupational exposure should be evaluated for HIV infection. Information available in the medical record at the time of exposure or from the source person may suggest or rule out possible HIV infection. If the source is known to have HIV infection, available information about this person's stage of infection (i.e., asymptomatic or AIDS), CD4+ T-cell count, results of viral load testing, and current and previous antiretroviral therapy, should be gathered for consideration in choosing an appropriate PEP regimen. If the HIV serostatus of the source person is unknown, the source person should be informed of the incident and, if consent is obtained, tested for serologic evidence of HIV infection. If consent cannot be obtained (e.g., patient refuses), procedures should be followed for testing source persons according to applicable state and local laws. Confidentiality of the source person should be maintained at all times. Exposed HCWs should be evaluated for susceptibility to bloodborne pathogen infections. Baseline testing (i.e., testing to establish serostatus at the time of exposure) for HIV antibody should be performed. If the source person is seronegative for HIV, baseline testing or further follow-up of the HCW normally is not necessary. If the source person has recently engaged in behaviors that are associated with a risk for HIV transmission, baseline and follow-up HIV-antibody testing (e.g., 3 and/or 6 months post exposure) of the HCW should be considered. Serologic testing should be made available to all HCWs who are concerned that they may have been exposed to HIV. 7.3 HIV post exposure prophylaxis (PEP) The following recommendations apply to situations where an HCW has had an exposure to a source person with HIV or where information suggests that there is a likelihood that the source person is HIV-infected. 7.3.1 Explaining PEP to HCWs Recommendations for chemoprophylaxis should be explained to HCWs who have sustained occupational HIV exposures. For exposures for which PEP is considered appropriate, HCWs should be informed that a) knowledge about the efficacy and toxicity of drugs used for PEP are limited; b) only ZDV has been shown to prevent HIV transmission in humans; 12 c) there are no data to address whether adding other antiretroviral drugs provides any additional benefit for PEP, but experts recommend combination drug regimens because of increased potency and concerns about drug-resistant virus; d) data regarding toxicity of antiretroviral drugs in persons without HIV infection or in pregnant women are limited for ZDV and not known regarding other antiretroviral drugs; e) any or all drugs for PEP may be declined by the HCW. HCWs who have HIV occupational exposures for which PEP is not recommended should be informed that the potential side effects and toxicity of taking PEP outweigh the negligible risk of transmission posed by the type of exposure. f) In consultation with an expert, (See Section 7.6) drugs for PEP should be customized by using any available information about the source’s antiretroviral history. 7.3.2 Timing of PEP Initiation PEP should be initiated as soon as possible. 7.3.3 PEP if Serostatus of Source Person is Unknown If the source person's HIV serostatus is unknown at the time of exposure (including when the source is HIV negative but may have had a recent HIV exposure), use of PEP should be decided on a case-by-case basis, after considering the type of exposure and the clinical and/or epidemiologic likelihood of HIV infection in the source. 7.3.4 PEP if Exposure Source is Unknown If the exposure source is unknown, use of PEP should be decided on a case-by-case basis. Consideration should include the severity of the exposure and the epidemiologic likelihood that the HCW was exposed to HIV. 7.3.5 PEP for Pregnant HCWs If the HCW is pregnant, the evaluation of risk and need for PEP should be approached as with any other HCW who has had an HIV exposure. However, the decision to use any antiretroviral drug during pregnancy should involve discussion between the woman and her health-care provider regarding the potential benefits and potential risks to her and her fetus. 7.4. Follow-up of HCWs exposed to HIV 7.4.1 Post exposure Testing HCWs with occupational exposure to HIV should receive follow-up counseling, post exposure testing, and medical evaluation regardless of whether they receive PEP. HIVantibody testing should be performed for at least 6 months post exposure 7.4.2 Monitoring and Management of PEP Toxicity If PEP is used, drug-toxicity monitoring should be performed at baseline and again 2 weeks after starting PEP. Clinical judgement, based on medical conditions that may exist in the 13 HCW and any toxicity associated with drugs included in the PEP regimen, should determine the scope of testing. 7.4.3 Counseling and Education Although HIV infection following an occupational exposure occurs infrequently, the emotional impact of the exposure often is substantial. In addition, HCWs are given seemingly conflicting information. Although HCWs are told that there is a low risk for HIV transmission, a 4-week regimen of PEP is recommended and they are asked to commit to behavioral measures (i.e., sexual abstinence or condom use) to prevent secondary transmission, all of which influence their lives for several weeks to months. Therefore, access to persons who are knowledgeable about occupational HIV transmission and who can deal with the many concerns an HIV exposure may raise for the HCW is an important element of post exposure management. HIV-exposed HCWs should be advised to use the following measures to prevent secondary transmission during the follow-up period, especially during the first 6-12 weeks after the exposure when most HIV-infected persons are expected to seroconvert: a) use sexual abstinence or condoms to prevent sexual transmission and to avoid pregnancy; b) refrain from donating blood, plasma, organs, tissue, or semen. c) If the exposed HCW is breastfeeding, she should be counseled about the risk for HIV transmission through breast milk, and discontinuation of breastfeeding should be considered, especially following high-risk exposures. There is no need to modify an HCW's patient-care responsibilities to prevent transmission to patients based solely on an HIV exposure. If HIV seroconversion is detected, the HCW should be evaluated according to published recommendations for HIV-infected HCWs. 7.5 Exposure Management for Hepatitis B Evaluation and testing of an exposure source should follow instructions given under HIV section. 7.5.1 Hepatitis B virus post exposure management For an exposure to a source individual found to be positive for HBsAg, the worker who has not previously been given hepatitis B vaccine should receive the vaccine series. A single dose of hepatitis B immune globulin (HBIG) is also recommended, if this can be given within 7 days of exposure. For exposures from an HBsAg-positive source to workers who have previously received vaccine, the exposed worker should be tested for antibody to hepatitis B surface antigen (anti-HBs), and given one dose of vaccine and one dose of HBIG if the antibody level in the worker's blood sample is inadequate. If the source individual is negative for HBsAg and the worker has not been vaccinated, this opportunity should be taken to provide hepatitis B vaccination. If the source individual refuses testing or he/she cannot be identified, the unvaccinated worker should receive the hepatitis B vaccine series. HBIG administration should be considered on an individual basis 14 when the source individual is known or suspected to be at high risk of HBV infection. Management and treatment, if any, of previously vaccinated workers who receive an exposure from a source who refuses testing or is not identifiable should be individualized. 7.6 Exposure Management for Hepatitis C Evaluation and testing of an exposure source should follow instructions given under HIV section. 7.9.1 Hepatitis C virus post exposure management For the person exposed to an HCV-positive source a) perform baseline testing for anti-HCV and ALT activity; and perform follow-up testing (e.g., at 4– 6 months) for anti-HCV and ALT activity (if earlier diagnosis of HCV infection is desired, testing for HCV RNA may be performed at 4 – 6 weeks). b) Confirm all anti-HCV results reported positive by enzyme immunoassay using supplemental anti-HCV testing (e.g., recombinant immunoblot assay [RIBA]) Health-care professionals who provide care to persons exposed to HCV in the occupational setting should be knowledgeable regarding the risk for HCV infection and appropriate counseling, testing, and medical follow-up. Immunoglobulin and antiviral agents are not recommended for PEP after exposure to HCV-positive blood. 15 Appendix A. Type and Duration of Precautions Needed for Selected Infections and Conditions Adapted from “Guidelines for Isolation Precautions in Hospitals” by the CDC Hospital Infection Control Advisory Committee. Published 1/1/96, updated 1/2007. Precautions Abbreviations: Type of precautions: A= Airborne D= Droplet C= Contact S= Standard When A, C, and D are specified, also use S. Duration of precautions: CN= until off antibiotics and culture-negative; DH= duration of hospitalization; DI= duration of illness (with wound lesions, DI means until they stop draining); U= until time specified in hours (hrs) after initiation of effective therapy; F= see footnote number. Infection/Condition Abscess Draining, minor or limited Acquired immunodeficiency syndrome Precaution Type S F(1) S Candidiasis, all forms including mucocutaneous S Chancroid (soft chancre) S Chickenpox (varicella; see F(2) for varicella exposure) Duration of Precaution A,C F (2) 16 Chlamydia trachomatis Conjunctivitis Genital Respiratory S S S Congenital rubella C F (3) Conjunctivitis S S S Acute bacterial Chlamydia Gonococcal Endometritis S Enterobiasis (pinworm disease, oxyuriasis) S Enteroviral infections Adults S German measles (rubella) D S Gonorrhea Granuloma venereum) F (4) inguinale (donovanosis, granuloma Hepatitis, viral Type A Type B -- HBsAg positive Type C and other unspecified non-A, non-B Type E Herpes simplex (Herpesvirus hominis) Mucocutaneous, disseminated or primary, severe Mucocutaneous, recurrent (skin, oral, genital) S S S S S C S DI A,C DI, F (4) S F (4) Herpes zoster (varicella-zoster) Localized in immunocompromised patient, or disseminated Localized in normal patient 17 Human immunodeficiency virus (HIV) infection Impetigo S C U (24 hrs) Infectious mononucleosis S Influenza D DI Lice (pediculosis) C U (24 hrs) Lyme disease S Lymphogranuloma venereum S Measles (rubeola), all presentations A Meningitis S Mumps (infectious parotitis) D Respiratory infectious disease, acute (if not covered elsewhere) Adults S Ringworm (dermatophytosis, dermatomycosis, tinea) DI F (5) S Rubella (German measles) D F (6) Scabies C U (24 hrs) Streptococcal disease (Group A strep.) Skin, wound, or burn Major (1) Minor or limited (2) C S DI Toxic shock syndrome S 18 Syphilis Skin and mucous membrane, including congenital, Primary, Secondary Latent (tertiary) and seropositivity without lesions S S S Tinea (fungus infection dermatophytosis, dermatomycosis, ringworm) S Toxic shock syndrome (staphylococcal disease) S Trichomoniasis S Tuberculosis Extrapulmonary, draining lesion (including scrofula) Extrapulmonary, meningitis Pulmonary, confirmed or suspected or laryngeal disease Skin-test positive with no evidence of current pulmonary Disease Urinary tract infection (including pyelonephritis) Varicella (chickenpox) Viral diseases Respiratory (if not covered elsewhere) Adults S S A F (7) S S A,C F (5) S 19 Footnotes: (1) Dressing covers and contains drainage adequately. (2) Maintain precautions until all lesions are crusted. The average incubation period for varicella is 10 to 16 days, with a range of 10 to 21 days. After exposure, use varicella zoster immune globin (VZIG) when appropriate, and discharge susceptible patients if possible. Place exposed susceptible patients on Airborne Precautions beginning 10 days after exposure and continuing until 21 days after last exposure (up to 28 days if VZIG has been given). Susceptible persons should not enter the room of patients on precautions if other immune caregivers are available. (3) Place infant on precautions during any admission until 1 year of age, unless nasopharyngeal and urine cultures are negative for virus after age 3 months. (4) Persons susceptible to varicella are also at risk for developing varicella when exposed to patients with herpes zoster lesions; therefore, susceptibles should not enter the room if other immune caregivers are available. (5) For 9 days after onset of swelling. (6) Until 7 days after onset of rash. (7) Discontinue precautions only when TB patient is on effective therapy, is improving clinically, and has three consecutive negative sputum smears collected on different days, or TB is ruled out. Also see CDC "Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Facilities." 1/6/00 20 Appendix B Task and Implications for Personal Protective Equipment Joint Advisory Work Classification Nature of Task / Activity Personal Protective Equipment Should Be: Available Worn I. Direct contact with blood or other body fluids to which universal precautions apply Yes Yes II. Activity performed without blood exposure but exposure may occur in emergency Yes No III. Task/activity does not entail predictable or unpredictable Exposure to blood No No 21 Appendix C Examples of Recommended Personal Protective Equipment for Worker Protection Against HIV and HBV Transmission (1) in Prehospital (2) Settings Task or Activity Disposable Gloves (3) Protective Gown Mask/Eyewear Bleeding control with Yes Yes Yes with spurting blood Bleeding control with Yes No No minimal bleeding Blood drawing Yes No No Starting an Yes No No intravenous (IV) line Handling and cleaning Yes No unless soiling No instruments with is likely microbial contamination Measuring blood No No No pressure Measuring No No No temperature Giving an injection No No No (1) The examples provided in this table are based on application of universal precautions. Universal precautions are intended to supplement rather than replace recommendations for routine infection control, such as hand washing and using gloves to prevent gross microbial contamination of hands (e.g., contact with urine or feces). (2) Defined as setting where delivery of emergency health care takes place away from a hospital or other health-care facility. (3) While not clearly necessary to prevent HIV or HBV transmission unless blood is present, gloves are recommended to prevent transmission of other agents (e.g., Herpes simplex). 22 Appendix D Reprocessing Methods for Equipment Used in the Prehospital1 Health-Care Setting (1) Reprocessing Methods Destroys Methods Use Sterilization All forms of microbial life Steam under pressure For those instruments or including high numbers of (autoclave),gas (ethylene devices that penetrate skin or bacterial spores. oxide), dry heat, or contact normally sterile areas immersion in EPAof the body, e.g., scalpels, approved chemical needles, etc. Disposable sterilant" for prolonged invasive equipment eliminates period of time, e.g., 6- the need to reprocess these 10 hours or according to types of items. When manufacturers' indicated, however, instructions. Note: liquid arrangements should be made chemical with a health-care facility for "sterilants"should be reprocessing of used only on those reusable invasive instruments. instruments that are impossible to Sterilize or disinfect with heat. High-Level All forms of microbial life Hot water pasteurization For reusable instruments or Disinfection except high numbers of (80-100 C, 30 minutes) or devices that come into contact bacterial spores. exposure to an EPAwith mucous membranes (e.g., registered "sterilant" laryngoscope blades, chemical as above, endotracheal tubes, etc.). except for a short exposure time (10 - 45 minutes or as directed by the manufacturer). Intermediate- Mycobacterium tuberculosis, EPA-registered "hospital For those surfaces that come Level Vegetative bacteria, most disinfectant" chemical into contact only with intact Disinfection viruses, and most fungi, but germicides that have a skin, e.g.-, stethoscopes, does not kill bacterial label claim for blood pressure cuffs, splints, spores. tuberculocidal activity; etc., and have been visibly commercially available contaminated with blood or hard-surface germicides bloody body fluids. Surfaces or solutions containing must be precleaned of visible at least 500 PPM free material before the germicidal available chlorine (a chemical is applied for 1:100 dilution of disinfection. common household bleach - approximately ¼ cup bleach per gallon of tap water). 23 Low-Level Disinfection Environmental Disinfection Most bacteria, some viruses, some fungi, but not Mycobacterium tuberculosis or bacterial spores. EPA-registered "hospital disinfectants" (no label claim for tuberculocidal activity). These agents are excellent cleaners and can be used for routine housekeeping or removal of soiling in the absence of visible blood contamination. Surfaces include floors, woodwork, ambulance seats, countertops, etc. Environmental surfaces which have become soiled, should be cleaned and disinfected using any cleaner or disinfectant agent which is intended for environmental use. (1) Defined as setting where delivery of emergency health-care takes place prior to arrival at hospital or other health-care facility. IMPORTANT: To assure the effectiveness of any sterilization or disinfection process, equipment and instruments must first be thoroughly cleaned of all visible soil. 24 Appendix E Basic and expanded post exposure prophylaxis regimens Regimen category Basic Expanded Application Drug regimen Occupational HIV exposures for 4 weeks (28 days) of both zidovudine which there is a recognized 600 mg every day in divided doses (i.e. transmission risk (Figure 1). 300 mg twice a day, 200 mg three times a day, or 100 mg every 4 hours) and lamivudine 150 mg twice a day. Occupational HIV exposures that Basic regimen plus either indinavir 800 pose an increased risk for mg every 8 hours or nelfinavir 750 mg transmission (e.g. larger volume larger volume of blood three times a of blood and/or higher virus titer day.* in blood) * Idinavir should be taken on an empty stomach (i.e. without food or with a light meal) and with increased fluid consumption (i.e. drinking six 8oz glasses of water throughout the day); nelfinavir should be taken with meals. From 2001 CDC: Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis MMWR. 25 Appendix F HIV post exposure prophylaxis resources and registries Resource or registry National Clinicians' Post exposure Hotline Antiretroviral Pregnancy Registry Contact Information Telephone: (888) 448-4911 or (888) PEP4HIV Write: 1410 Commonwealth Drive Suite 215 Wilmington, NC 28405 Telephone: (800) 258-4263 Fax: (800) 800-1052 Write: 1410 Commonwealth Drive Suite 215 Wilmington, NC 28405 Food and Drug Administration (for reporting Telephone: (800) 322-1088 unusual or severe toxicity to anti- retroviral agents) CDC (for reporting HIV seroconversions in Telephone: (404) 639-6425 health-care workers who received PEP) 26