EXPOSURE CONTROL PLAN FOR OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS (BBP) FOR THE U.S. ENVIRONMENTAL PROTECTION AGENCY NATIONAL ENFORCEMENT INVESTIGATIONS CENTER (NEIC) PREPARED BY U.S. PUBLIC HEALTH SERVICE DIVISION OF FEDERAL EMPLOYEE OCCUPATIONAL HEALTH REGION VIII FEBRUARY 23, 1993 ------- EXPOSURE CONTROL PLAN FOR NEIC OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS TABLE OF CONTENTS SECTIONS : PAGE INTRODUCTION 1 EXPOSURE DETERNINATION METHODS OF COMPLIANCE 8 EXPOSURE INCIDENT 16 TRAINING 17 RECORDKEEPING 19 BIOHAZARD WASTE 21 APPENDICES : A. OSHA Bloodborne Pathogens Standard (1910.1030). B. Exposure Incident and Treatment Packet C. Hepatitis B.Availability Vaccination Information D. Reference Information on Hepatitis B Infections from MMWR. E. Optional Post-Exposure Testing for Human Ixnmunodeficiency Virus (HIV): Information and Consent/Declination Forms F. Reference Information on HIV Infections from MNWR. G. Training Packet H. Information for Ordering Approved Sharps Containers. I. California Morbidity Report - Information on Exposure Risk From Waste Water and Sewage ------- NEIC Exposure Control Plaxv Bloodborne Pathogen Exposures Page 1 SECTION I: INTRODUCTION This Exposure Control Plan for Occupational Bloodborne Pathogen (BBP) Exposure has been developed for the U.S. Environmental Protection Agency, National Enforcement Investigations Center (NEIC), by the U.S. Public Health Service (PHS), Division of Federal Occupational Health (FOH). The document has been developed in accordance with the CDC guidelines and the OSHA Bloodborne Pathogens Standard (1910.1030) to protect all NEIC employees from occupational exposure to blood or other potentially infectious materials. A copy of the Standard is included in Appendix A. The document is presented in seven main sections: I. Introduction II. Exposure Determination This section presents a method for determining bloodborne pathogen exposure risks for NEIC employees. A list of NEIC job classifications has been compiled in which employees may be potentially exposed to bloodborne pathogens. In some instances, specific tasks and procedures have also been identified in which occupational exposure may reasonably be expected to occur. In addition, there may be other potential occupational exposure settings not covered by these lists. III. Methods of Compliance This section discusses work practice controls which shall be used to minimize or eliminate employee exposure. Included in this section is the use, accessibility, cleaning, repair and replacement, and disposal of personal protective equipment (PPE). IV. Handling Exposure Incidents This section discusses NEIC procedures once an exposure occurs. Exposure incident means a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials. ------- NEIC Exposure Concrol Plan Bloodborne Pathogen Exposures Page 2 V. Training This section discusses the required information needed for training. ------- NEIC Exposure Control Plan Bloodborne Pathogen Exposures Page 3 SECTION II: EXPOSURE DETERMINATION Contents of this section : A. Need for Identifying Increased Risk Groups B. Definitions C. Work Activities with Increased Risk D. Estimating Exposure Risks for Specific Jobs/Tasks A. NEED FOR IDENTIFYING INCREASED RISK GROUPS This section presents a mechanism to determine which NEIC employees may be at increased risk for occupational exposure to bloodborne pathogens (BBP), as required by the OSHA Bloodborne Pathogens Standard. Such employees at increased risk need to be included in special programs designated by the Standard including special training, issuance of personal protective gear (i.e., gloves and airway masks for CPR) and the availability of immunization for Hepatitis B and gamma globulin for treatment after exposure. Employees determined to not be at increased risk for exposure are not covered by the Standard. However, the PHS recommends that all employees receive limited information about certain aspects of the Standard, whether or not they are considered in the increased risk group. Such information should include availability of protective equipment at first aid stations and post-exposure treatment/monitoring procedures if a BBP exposure occurs. B. DEFINITIONS 1. Occupational exposure means reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee’s duties. The determination of potential exposure is made without regard to whether the employee uses personal protective equipment such as gloves. 2. Other potentially infectious materials means human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids. ------- NEIC Exposure Control Plan. B].oodborne Pathogen Exposures Page 4 C. WORK ACTIVITIES WITH INCREASED RISK It is reasonable to assume that some NEIC workers will be at increased (i.e., moderate or high) risk for these exposures based on the nature of their jobs. There appear to be four general types of job tasks or exposure settings where NEIC employees MIGHT be at SOME risk for exposure to bloodborne pathogens. NEIC employees who should be considered at increased risk for such BBP exposures are identified below in each of the four categories. 1. First Aid Providers a. First aid providers for co-workers (an increased risk group): Some employees may be part of work groups which are at times remote from emergency medical services and/or may do tasks which pose a significantly increased risk for injury. In such work groups or settings these employees would be formally designated to serve as “first responders” in performing first aid on injured co—workers. In these instances, first aid training and the providing of such first aid to injured co—workers are a required or expected part of job duties. For the purposes of the Standard, such an expectation might be felt to exist unless it is explicitly and formally excluded in the written part of the job description or as an explicit policy clarification is issued to all employees. These employees would be in the increased risk group. b. Voluntary or “Good Samaritan” first aid providers (a low risk group): A distinction should be made between: (1) employees described in parts 2.a. above, who are required or expected to provide first aid as a part of their jobs and are in the increased risk group, versus (2) employees who receive first aid training primarily for their own benefit and are not designated or expected to perform first aid as part of their job, who are at low risk. Such employees may at times perform first aid on a voluntary basis as “Good Samaritans.” Since they are not required to do this as part of their jobs, they would not be considered in the increased occuDational risk group. However, if these employees should become exposed at work because of voluntary or “Good Samaritan” actions, they would still be covered by parts of the Standard dealing with exposure treatment and post-exposure monitoring. In addition, first aid training for all groups should cover the issue of BBP exposure and preventive measures. ------- NEIC Exposure Control Plan Bloodborne Pathogen Exposures Page 5 2. Workers Engaged in Field Activities Employees engaged in field activities (e.g., hazardous waste disposal sites or sanitary landfills) might have occasional exposure to potentially infectious materials. This would be particularly true with sites at which employees directly handle biohazard wastes or wastes from health care facilities. General landfills and illegal garbage dumps might also contain potentially infected materials. In general, since the contents of hazardous waste sites and landfills are usually not known with certainty, the most prudent policy may be to consider all employees who may work at such sites and who directly handle materials to be included in the increased risk group. Alternately, workers assigned only to overview or supervisory tasks at these sites, who have no direct contact with waste material, would be at low risk . In addition, well—characterized and regulated hazardous waste land fills which only contain known chemical wastes are probably also low risk settings for BBP exposures. Employees who may work- at waste water treatment facilities or with waste water effluent are probably at low risk unless they directly handle raw sewage. (See Appendix I). 3. Laboratory Exposures Employees in laboratory settings should be considered at increased risk for BBP exposures they handle any human specimens (i.e., blood or other body fluids or tissues). Because of the possibility of glass sample container breakage, laboratory workers iay also be at increased risk if they handle other materials which are potentially contaminated by BBP (e.g., solid samples of unknown materials from hazardous waste sites or any samples from crime labs, etc.) 4. Other Exposure Settings There may other circumstances not noted above when a NEIC employee might be at increased risk for exposure to bloodborne pathogens. These may need to be determined on a case-by—case basis. Therefore some general educational information or brief training on the risks of bloodborne pathogeris will probably need to be given to all NEIC employees. 0. ESTIMATING EXPOSURE RISKS FOR SPECIFIC JOBS/TASKS After assessment of all NEIC activities, job titles, and potential for exposure, PHS has determined that only ------- NEIC Exposure Control Plan: Bloodborne Pathogen Exposures Page 6 employees engaged in field activities in the Criminal Enforcement Branch with the following titles constitute an increased risk group: Supervisory Environmental Scientist, Environmental Protection Specialist, Environmental Investigation Specialist, Environmental Scientist, Environmental Engineer, and Physical Science Technician. However, supervisors and employees should review all job duties and tasks to assess whether any of the previously identified increased risk activities are part of the employee’s job description. Those employees not included in the increased risk group above, but who feel they are at increased risk for occupational exposure to BBP, should be encouraged to discuss this with their supervisor or safety officer. In addition, managers and safety officers should be asked to identify increased risk worker groups or individuals not included in the categories above. These situations should be discussed with the appropriate public health personnel and individual decisions should be made on whether such employees should be considered in the increased risk group. ------- NEIC Exposure Control Plan Bloodborne Pathogen Exposures Page 7 SECTION III: METHODS OF COMPLIANCE Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall be used. A. DEFINITIONS 1. BLOODBORNE PATHOGENS Bloodborne pathogens are defined as pathogenic microorganisms present in human blood which can cause disease in humans. These bloodborne pathogens include, but are not limited to, Hepatitis B virus (HBV) and human iinirtunodeficiency virus (HIV or AIDS virus). 2. OTHER POTENTIALLY INFECTIOUS MATERIALS Other potentially infectious materials are defined as the other types of body fluids and tissues besides blood which are potentially capable of causing disease. The OSHA Standard specifically defines other potentially infectious materials to include: semen, vaginal secretions, fluids from internal body spaces (such as spinal fluid or joint fluid), any body fluid visibly contaminated with blood, and all body fluids where it is difficult or impossible to differentiate between body fluids. Also included are any human tissues other than intact skin (unless the tissue has been fixed by histology procedures) and tissue culture and potentially infected experimental animals used in medical research. The Standard does not specifically include tears, vomit, urine, or fec es on this list unless visibly contaminated with blood. However, from a practical point of view, tears, vomit, urine, and feces should be regarded by employees as if they were potentially infectious, and the same precautions should be used as when dealing with blood and the other potentially infectious material specifically mentioned in the Standard. In disposing of tears, vomit, urine, and feces, these need not be treated as hazardous materials (see below) as long as they are not visibly contaminated with blood. It should be mentioned here that a number of serious human diseases can be transmitted by urine, feces, etc., even in the absence of blood. While such transmissions are not covered by the Standard unless contaminated with blood, they should still be regarded as potentially dangerous. ------- EIC Exposure Control Plan: Bloodborne Pathogen Exposures Page 8 3. ENGINEERING CONTROLS Engifleerina controls means control measures that isolate or remove the bloodborne pathogens front the workplace. These might include such things as special containers for disposal of contaminated needles or self—sheathing needles, or - automated handling of contaminated materials. 4. ExPOSURE INCIDENT Exposure incident is defined as a specific contact of blood or other potentially infectious materials with a person’s eye, mouth, other mucous membrane, non—intact skin, or by parenteral contact (i.e., by a puncture wound or cut with a contaminated object such as a hypodermic needle). 5. PERSONAL PROTECTIVE EQUIPMENT Personal protective eauipment includes items an individual employee may use to prevent contamination by potentially infectious material. In the case of bloodborne pathogens, such personal protective equipment might include gloves, eye protection or face shields, masks covering the mouth, and protective clothing. (See specific information below.) 6. SHARPS Sharps are defined as all sharp items which may become contaminated with potentially infectious materials (this is primarily relevant to health care or lab settings). Sharps include all hypodermic needles, scalpel blades, glass lab pipettes or other sharp instruments considered as potentially infective and must be handled with extreme care to prevent accidental injuries. 7. UNIVERSAL PRECAUTIONS Universal precautions are defined as the standard precautions all persons should use to prevent contact with blood or other potentially infectious materials whenever these situations occur or are anticipated. These may involve standard work practices and the use of personal protective equipment such as gloves, protective clothing, eye protection, and/or masks. (See more information in Section III.B.l., below). ------- NEIC Exposure Control Plan Bloodborne Pathogen Exposures Page 9 B. APPROVED GENERAL WORK PRACTICES 1. UNIVERSAL PRECAUTIONS universal precautions should be used by all employees whenever the potential for exposure to bloodborne pathogens exists. Employees should adhere rigorously to the infection control precautions noted in this section in order to minimize the risk of exposure to blood and other body fluids. All body fluids shall be considered potentially infectious materials. All protective equipment needed to protect workers will be supplied, cleaned, disposed of, repaired, or replaced by NEIC. Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in areas where there is a reasonable likelihood of occupational exposure to bloodborne pathogens. Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets, or on counters where blood or other potentially infectious materials are present. 2. USE OF GLOVES Gloves are to be worn when it can be reasonably anticipated that an employee’s hands may be in contact with blood or other potentially infectious materials, including touching contaminated items or surfaces. Gloves should be located at appropriate sites for easy access. Hands shall be washed thoroughly and inunediately after possible contact with blood and/or body fluids as well as before putting on and after taking off of the gloves. Gloves must be of appropriate material, latex, vinyl, or rubber and of appropriate size for each worker. In a health care setting when doing procedures where gloves are needed, the gloves should be changed each time a new patient is being dealt with. Anytime the gloves are contaminated with blood and/or other body fluids, the gloves must be changed and disposed of as noted below. For field settings, thick non—disposable gloves of the materials identified above are acceptable so long as their surface is not cracked or abraded and the gloves are sterilized after each potential exposure. (See Section III.B.4. below on cleaning contaminated materials.) 3. USE OF RESPIRATORS, EYE PROTECTION, AND FACE SHIELDS Respirators or eye protection and face shields shall be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated. ------- NEIC Exposure Control Plarv Rloodborne Pathogen Exposures Page 10 C - 4. USE OF BODY CLOTHING Coveralls, lab coats, aprons, and other protective body clothing shall be worn in occupational exposure situations. If contaminated, these clothing should be discarded (if disposable) or placed in a special receptacle to be cleaned (see Section III.B.7. below on handling contaminated linen). Plastic and rubberized aprons or gloves should be cleaned first by rinsing with soap and water, and then disinfected using a bleach solution (as noted below) or similar disinfectant recommended by the manufacturer. 5. HANDLING AND DISPOSAL OF SHARPS a. All used or potentially contaminated sharps should be disposed of in puncture-resistant Approved Sharps Containers located as close as practical to the area of use. Needles or glass pipettes are not to be recapped, purposefully bent, broken, removed from disposable syringes, or otherwise manipulated by hand . The sharps containers shall be located in all areas where needles and sharps are commonly used. (See Appendix H for approved and suggested sharp containers). b. When an Approved Sharps Container is full, it should be labelled as BIOHAZARD, sealed, disinfected using the bleach solution described below by pouring the solution into the container, label as BIOHAZARD, and sealed. The container should then be allowed to sit for 24 hours before being disposed of. 6. USE OF RESUSCITATION (CPR) EQUIPMENT Pocket masks and resuscitation bags will be provided in all First Aid Kit or emergency boxes intended for resuscitation. Resuscitation bags or pocket masks shall be used for all resuscitation where emergency mouth-to—mouth resuscitation is indicated. “- Pocket cardiopulmonary resuscitation (CPR) masks and gloves should also be available in all non-CPR first aid kits, and should be used by any individual adrn:nistering CPR or first aid. In addition, individuals who are required to be first aid certified as part of their jobs may wish to carry their own small packet containing gloves and a pocket mask for CPR. 7. HANDLING CONTAMINATED LINEN Linen contaminated with blood and/or other body fluids shall be placed in a laundry bag and labelled. If the bag is ------- NEIC Exposure Control Plan Bloodborne Pathogen Exposures Page 1.1. punctured or if outside contamination of the bag is likely, a second bag shall be used. Gloves shall be worn when working with linen contaminated with blood and/or other body fluids. 8. CLEANING BLOOD AND/OR BODY FLUID SPILL The following procedures should be utilized for cleaning up blood or body fluid spills: a. Area of the spill shall be cordoned of f to prevent the accidental spread of body fluids. b. Vinyl or latex gloves are donned if not already in place. c. An appropriate germicide or bleach solution should be prepared. A germicide solution is the cleaning solution of choice. If a bleach solution is used it can be prepared with 800 ppm NaC1O solution (i.e., standard household chlorine bleach) by mixing a quarter cup (60 ml) with one gallon of water. The bleach solution should only be used on hard floors. Do not use this solution on carpet . Bleach solution should be made fresh; never hold more than one day’s worth at a time unless it is stored in an air-tight container in a cool dark place. d. Remove any large pieces of glass or other particulate material. Do not pick up material, with hands . Use a plastic scoop to remove this matter. A tongue depressor may be employed to maneuver items onto the scoop. Care should be taken not to flip material with the tongue depressor. Particulate material and tongue depressors are placed in a puncture-resistant and splatter-proof container. The scoop is placed in a clean place after being cleaned (see 8.h., below). e. Carefully remove the body fluids from the spill surface with gauze sponges. When the sponge is saturated, replace it with a new one. Do not wring out fluids . All soiled sponges are placed in the puncture-resistant and splatter-proof container. f. Once body fluids have been removed from the area, the bleach solution is used to decontaminate the area. This is done by starting two (2) inches outside the spill and moving into the center of the spill by making a series of overlapping concentric circles with a sponge. The area is allowed to air dry and the process is repeated. The soiled sponges are placed into the puncture- resistant splatter—proof container. ------- NEIC Exposure Control Plan Bloodborne Pa hogen Exposures Page 12 g. All material used in the cleanup are placed in a safe holding area until they can be disposed of in accordance with Section C.3., below. h. All material in the container is disinfected in accordance with usual procedure for sharp containers. The germicide or bleach solution may be disposed of in a sanitary sewer; large quantities may be harmful to septic tank systems. The scoop may be allowed to air dry. NOTE: If it is desired to neutralize via the NaClO solution, there should be a minimum contact time of 10- minutes in the solution. C. SPECIFIC PROCEDURES FOR HANDLING POTENTLY EXPOSURES 1. General Exposures: a. Cleaning Spills See specific instructions in Section III.B.8. b. Emesis Gloves must be worn when handling, cleaning, and/or disposing of emesis fluid. c. Iniuries Gloves are to be worn whenever blood and/or other body fluids are present. d. CPR Follow instructions in Section III.B.6. regarding CPR and cleaning of resuscitation equipment. e. Disposal of Syringes/Need1es/ Pipettes Please follow the instructions for sharps in Section III.B.5. f. Reusable Instruments Gloves must be worn in handling any contaminated instruments. g. Special Note on Exposures of Pregnant Women Pregnant women are not known to be at greater risk of contracting HBV or HIV infections than workers who are not pregnant. However, if a worker develops HIV infection during pregnancy, the infant is at increased risk of infection resulting from perinatal transmission. Because of this risk, pregnant women should be especially familiar with the above precautions. ------- NEIC Exposure Control Plan Bloodborne Pathogen Exposures Page 13 SECTION IV: EXPOSURE INCIDENT A. DEFINITION OF EXPOSURE INCIDENT “Exposure Incident” refers to a specific eye, mouth, other mucous membranes, non—intact skin, or parentera]. contact with blood or other potentially infectious material that results from the performance of an employee’s duties. B. WHAT TO DO IF AN EXPOSURE INCIDENT OCCURS If an exposure incident occurs, the employee should be given the “Exposure Incident and Treatment Packet” (Appendix B). This packet contains all necessary instructions. It should be completed by the employee and taken with them to the designated medical clinic: federal employees to the FEOH Health Unit physician or insurance provider; for contractors, to their private health care provider (this is at the cost of the contractor). The health care provider seeing the employee at that clinic is to complete appropriate portions of the packet and use the information provided in the packet to determine appropriate treatment. The completed packet is to be returned to the NEIC where it will be kept as a permanent part of the employee’s occupational health record. This report only states that the employee was (1) evaluated and treated if appropriate for a bloodborne pathogen exposure incident and (2) was offered Hepatitis B vaccine if appropriate. All other information is considered medically confidential and is available only to the employee, their designees, health professionals, and others as designated in the OSHA Standard. These provisions are in accordance with OSHA standards with respect to exposure incident procedures and record keeping. ------- NEIC Exposure Control Plan: Bloodborne Pathogen Exposures Page 14 SECTION V: TRAINING A. GENERAL TRAINING REQUIREMENTS The OSHA Bloodborne Pathogen Standard requires initial training with annual updates for employees who are at increased risk for bloodborne pathogen exposure. As described in Section II on exposure determination, employees can probably be classified in terms of their BBP exposure risk based on their specific job/task assignments. Therefore, two levels of training will occur as described below: B. SPECIFIC LEVELS OF TRAINING 1. Training Level I: For NEIC Employees a. Groups to be Included : NEIC Employees All NEIC employees will receive some basic information about BBP exposure risks and should have an idea of what the agency’s BBP Exposure Plan covers. This type of training is not required by the OSHA Standard for groups with no increased risk; however, it seems prudent since employees may hear about the program from others and this may raise concerns or questions. Also, all employees may occasionally come across blood or a body fluid spill, at work or at home, and they should know how to handle these situations. b. Content of Training This will include at minimum a memo sent to all federal employees stating that the NEIC is instituting a BBP Exposure Control Plan as per the OSHA Standard. It should be stated that employees felt to be at increased risk from occupational BBP exposure will be contacted by their supervisor or designee. The memo should also state gloves and CPR face masks should be in all first aid kits and should be used in performing any first aid. If an employee notes a blood or body fluid spill they should be told who to contact to assure proper cleaning. A small pamphlet on occupational BBP exposure could be included. If appropriate, a brief description of the BBP Exposure Control Plan might be presented at a regular staff or safety meeting. Alternately, all NEIC employees can be included in the initial training for employees in the increased risk group. ------- NEIC Exposure Control Plan Bloodborne Pathogen Exposures Page 15 2 raifliflq Level II: NEIC Employees with Increased Work Exposure Risk a Groups Included : All employees determined to be in the I creased risk group should receive this level of training. b. Content of the Training : This will be an overview of all the material in the BBP Exposure Control Plan. The format of this training should be a classroom setting primarily focusing on Sections II, III (Sections A.l. through C.l.), IV, and VI of this document. c. Anticipated training time: 1—2 hours. Additional information such as record forms, brief training outlines, etc., are included in Appendix G. ------- NEIC Exposure Control Plan: Bloodborne Pathogen Exposures Page 16 SECTION VI: RECORD KEEPING A. MEDICAL RECORDS 1 • General Requirements for Medical Record Maintenance The U.S. Public Health Service, division of Federal Employee Occupational Health and NEIC are required to establish and maintain an accurate record for each federal employee at increased risk for occupational exposure in accordance with the Standard. All medical records are to be kept confidential and not disclosed or reported to any person within or outside the workplace without the employee’s express written consent except as required by law. Each record is to be maintained for at least the duration of employment, plus 30 years, in accordance with the Standard. 2. Specific Components of Medical Records to be Kept by NEIC for Potentially Exposed Employees These records shall include: a. The name and social security number of the employee. b. A copy of the employee’s Hepatitis B vaccination status if accepted by the employee including the dates of all the Hepatitis B vaccinations and any medical records relative to the employee’s ability to receive vaccination. (See Appendix C on Hepatitis B Vaccination). If the employee declines vaccination, a copy of the signed declination statement will be included. c. The employer’s copy of the health care professional’s written opinion if actually exposed. d. A copy of the information provided to the health care professional during the evaluation of an exposure incident (such as the document included as Appendix C.) B. TRAINING RECORDS 1. General Requirements of Training Record Maintenance Training records shall be maintained by NEIC for three years from the date on which the training occurred. ------- NEIC Exposure Control Plan. Bloodborne Pathogen Exposures Page 17 SECTION VII: BIOHAZARD WASTE A. GENERAL REQUIREMENTS FOR HANDLING BIOHAZARD WASTE All regulated waste shall be disposed of in accordance with applicable regulations of the United States, as well as the States and Territories and their political subdivisions. The OSHA Bloodborne Pathogens Standard does not appear to require any measures which are not already mandated by these regulations. However, general guidelines for handling biohazard waste are given below. The OSHA standard, in Appendix A, can be consulted for more information. B. SPECIFIC GUIDELINES FOR HANDLING BIOHAZARD WASTES 1. The containers for storage, transport, or shipping shall be labelled or color-coded and closed prior to being stored, transported, or shipped. 2. If contamination of the outside of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, or shipping and is labeled or color-coded. 3. If the specimen could puncture the primary container, the primary container shall be placed within a secondary container which is puncture-resistant in addition to the above characteristics. Equipment which may become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall’ be decontaminated ‘as necessary, unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible. 4. Regulated waste need not be handled as biohazard waste if it has been properly disinfected, except for “sharps” as described in Section III. 5. Communication of the hazards of potential exposure must be made to all individuals who deal with biohazard wastes. ------- APPENDIX A ------- APPENDIX A OSHA BLOODBORNE PATHOGENS STANDARD (1920.1030) ------- Federal Register / VoL 56 No 235 / Friday. December 6. 1991 / Rules and Regulations 64175 Xl. Tb. Standard Geneiel Lndustr,’ Part 1910 of title 36 of the Code of Federal Regulations is amended u Foilow PART 1910—(AMENDEDJ Subp*rt Z—{Am.nd.dl I The general authority citation for subpart Z of 36 CFP. part 1910 conneue, to read as follows and a new atation for § 1910.1030 Ii added Autherlir Seea.i and a. O p.ne i S.dety end Health Act. 36 U.S.C. 655. 657. Se tlary of Labors Order, Nos. 12-71(36 FR &S11. B— 9(41 FR o5e). orO -63(46 FR 337361. as apphcable and 36 ‘R past liii. • . . . . SecOon iaio.imu also heard under 36 U.S.C. 653. • • . . . 2. Section 1910.1030 ii added to read as follows. 1910.1030 Bloo oeso Pauiogans . (a) Scope and Apphcotion. This sec*i applies to all occupational exposwe to blood or other potentially tnfectioea materials as ii.d by paragraph (b) of this saction. (b) Definitions. For purposes of this section. the following shall appiy Awatant Seaetar,’ n ins the Assistant Seoretary of Labor far Occupational Safety and Health, or designated iepresentath’e. Bood , np hu iian blood. human blood components. and products made from human blood. Bloodbwna Pathogen, means pathogenic oorganisma that axe present in human blood and can cause disease in hu’n .s, These pathogen, induce. but are not limited to. hepatitis B virus (F V) and human lmnunodefl eucy virus (1•U ’v). C :nzcaJ Laborator means a workplace where dlageostlc or other eenang procedures axe performed an ., blood or other potentially infectious materials. Contaminated means the presence or the reasonably anticipated presence of blood or other potentially infectious enalj on an item or surface. Contaminated Lcwrthy mans liiimdiy which has been soiled with blood or other potentially iofect oui materials or may contain sharps. Contammatad Sharps muses any Contaminated object that can penetiete the s including but not limited to. needle,, scaip.I broken glass. broken Capillary tubes. and exposed end, of denial wires. Decontamination means the use of ptiysical or chemical means to remove. inactivate, or destroy bloodbonie pathogen, on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item ii rendered site for handling use, or disposaL Director means the Director of the National Institute for Occupational Safety and Health. U.S. Depar eni of Health and Human Services. or designated representative. Engineering Controls means controls (e.g.. sharps disposal containfra, self. sheathing needles) that isolate or remove the bloodborne pathogens hazard from the workplace. Exposwe incident means a specific eye. mouth. other mucous membrane. Don-intact skth. or parenterul contact wnh blood or other potentially infectious materials that results from the performance of so employee’s duties. Handwashjr,g Facilities means a facility providing an adequate supply of ri mrig potable water, soap and single use towels or hot air drying machines. Licensed Healthcwe Professional is a person who,, legally permitted scope of practice allows lamar her to Independently p 1 rf the activities required by paragraph (I) Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up. 11EV means hepatitis B virus. !IIV means human immunodeflctency means reasonably anticipated skin, eye. mucous membrane, or parentersi contact with blood or other potentially Infectious materials that may r siilt from the perforinei , of an employee’. duties. Other Potentially infectious Materials means (1) The following human body fluids . semen. vaginal secietrona, cerebrosainal fluid, synoviel fluid, pleural fluid. pencarthel fluid. peritoneal fluid. amniotic fluid, saliva in dental procedures, any body fluid that is visibly contn’pted wtth blood. and alt body fluids in situtia s where it is difficult or impossible to differentiate between body fluids, (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead): sod (3) HIV -onntaliung cell or tissue cultures, organ cultures. and )‘DV. or HBV.cont u tng culture medium or other solutions: and blood. organs. or other tissues from experimental em,n k Infected with I’IIV or } V. Pu,enteral means piercing mucous membranes or the skin barrier through such events as needlestidin, human bites, cuts. and abrasion,, Pe.’sor7ol Protective Equipment is specialized clothing or equipment worn by an employee lot protection against a hazard. General work clothes (e.g.. uniforms, pans, shirts or blouse,) not intended to function as protection against a hazard are not considered to be personal protective equipment. Production Facility means a facility engaged in industr.al.scale. large’ volume or high concentration production of HIV or V. Regulated Waste means liquid or semi-liquid blood or other potentially infectious materials: cont vu ln ted items that would release blood or other potentially infectious materials in a liquid or semi4iqwd state if compressed. items that are caked with dried blood or other potentially infectious material, and are capable of releasing these mat.nal, during h IIl!n,r contaminated sharps. and pathological and micioiclogrcai wastes contnrni’ig blood or other po .fthoIly infectious materials. Research Laboratory means a laboratory producing or uning research- laboratory-scale amounts of HiVor l’IBV. Research laboratories may produce high concentrations of IOV or HBV but not In the volume found c i production facilities. Source indiVidual means any individual. living or dead. whose blood or other potentially infe’c ’ous materials may be a source at oompational expoo to the employee Examples Include. but are not limited to, hospital and clinic patients. ‘ “ • in Institutions for the developmentally disabled. trauma victims. clients of drug and alcohol treaneent facilities. residents of hospicas and nursing homes. human remains. and individuals who donate or sell blood or blood components. Sterilize means the use of a physical or chemical procedure to destroy all maci ’obisl life tv... 1 1u 4 !?lg highly resistant bacterial endospores. UrnversoJPrecoutions 1, an approach to infection control. According to the concept of Universal Precautions, all human blood and certain human body fluids are treated as if own to be infectious for I’flV. HBV. and other bloodliorite pathogens. Woik Practice Controls mean, controls that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles bye two-handed technique). fc) Lrporurr contra/— fl) Łaposuze Control Plan. (i) Each employer having an employee(s) with occupational exposure as defined by paragraph (b) of this section shall establish a written Exposure Control Plan designed to ------- 64176 Federal Register / VoL 56. No. 235 I Friday. December 6. 1991 I Rules arid Regulations eliinlflate or minimize employee exsUre Exposure Cou ol Plan shall contain at least the following elemeritsi (A) The exposure determination required by paraçuph(c)(2), (B) The schedule and method of implementation for paragraphs (di Methods of Compliance. (e) j and i mv Research Laboratories and production Facilities. (f) Hepatitis B Vaccination and Post-Exposure Evaluation and Foliow.up. (g) Counication of Hazards to Employees. and (h) Recozdkeeping. of this standard. and (C) The procedure for the evaluation of cir atances surrounding exposure incidents as required by paragraph (fl(3)(i) of this standard. (iii) Each employer shall ensure that a copy of the Exposure Conti ol Plan is accessible to employees in accordance with 29 R 191O. (e). (iv) The Exposure Con ol Plan shall be reviewed and updated at lust nrinnally and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with ocinipatlonal exposure. (v) The Exposure Control Plan shall be made available to the Assistant Seoretary and the Director upon request for exsmin bon and copytng. (2) Lrposure determznog,on. ( I) Each employer who baa an employee(s) with occupational expo. as defined by paragraph (b) of this section shall prepare an exposw det muziabos. This exposure determination shall contain the following: (A) A list of all job classifications in which all employees in those job classifications have occupational exposure: (B) A list of job classifications ic which some employees have accupaUon j exposure, and (C) A list of all tasks and procedure, or groups of closely related task and procedures in which occupational exposure occurs and that are perf ed by employee, in job classifications listed in accordan with the provisions of pararraph (cl(2)(i)(B) of this standard. (ii) This exposure determination shall be made without regard to the use of personal protective equipment. (d) Methods of compl,once....(1) Geflem/—..tJmve , precautions shall be observed to prevent contact with blood or other potentially infectious materials. tinder 5thnre, which differentiation between body fluid types is difficult or impossible. all body fluids shall be considered potentially infectious materials. (2) Engineering and work practice controls. (I) Engineering and work practice controls shall be used to phmn!t te or itnu’use employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall also be used. (ii) Engineering controls shall be examined arid maintained or replaced on a regular schedule to ensure their effectiveness. (iii) Employer, shall provide handwashing facilities which are readily accessible to employees. (iv) When provision of handwaihing facilities is not feasible. the employer shall provide either an appropriate antiseptic hand cleanser in conjunction with clean cloth/paper towels or antiseptic towelettes. When antiseptic hand cleanser, or towelettes are used. hands shall be washed with soap and rimntng water as soon as feasible. (v) Employer, shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment (vi) Employer, shall ensure that employees wash 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 infectIons materials. (v ii) Conr ml’ inted needles and other con’-. ’mnted sharps shall riot be bent. recapped, or removed except as noted in paragraphs (d)(2)(vii)(A) and (d)(2)(vlI)(B) below. Shearing or breaking of con’ ”’a ted needjes is prohibited. (A) Contsmhuited needles and other conth ntn ted sharps shall not be recapped orremoved unless the employer can demonstrate that no alternative is feasible or that such action I. required by a specific medical (B) Such recapping or needle removal must be accomplished through the use of a mechanical device or a one-handed technique. (viii) Immediately or as soon as possible after use. conre unAted reusable sharps shall be placed in appropriate container, until properly reprocessed. These containers shall be: (A) Puncture resistant (B) Labeled or color-coded an accordance with this standard (C) Leakproof on the aides and bottoini and CD) In accordance with the requirements set forth In paragraph (d)(4)(tl)(E) for reusable sharps. (ix) Eating, drinking, smoking. applying cosmetics or lip balm, and handling contact lenses are prohibited an work areas where there is a reasonable likelihood of occupational exposure. (x) Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present. (xi) All procedures Involving blood or other potentially infectious materials ahall be performed in such a mn’in.r as to m n ure spl.s.hing spraying. spattering, and generation of droplets of these subst ni ’ .. (all) Mouth plperting/suctioning of blood or other potentially infectious materials is prohibited. (sill) of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, h rtdling , processing. storage, transport or (A) ’ e container for storage. transport or shipping shall be labeled or color-coded according to paragraph (g)(1)(i) and closed prior to being stored. transported, or shipped. When a facility utilizes Umversai Precautions In the h iidlmg of all specimens, the labeling! color-coding of spe mens is not necessary provided containers are recognizable as containing specimens. This exemption only applies while such specimens/containers remain within the facility. Labeling orcalor .coding an accordance with paragraph (g )(1)(i) is required when such specimens! containers leave the facility. (B) If outside con’ ”.ton of the primary container o rs , the primary container shall be placed within a second container which prevents leakage during h Iing . processing. storage. transport or shipping and is labeled or color-coded according to the requirements of this standard. (C) If the specimen could puncture the primary container, the primary container shall be placed within a secondary container which as puncture-resistant in addition to the above characteristics. (xiv) Equipment which may become conta , nated with blood or other potentially infectious materials shall be e ?iIt ed prior to servicing or shipping and shall be decontimrn. ted as necessary. anless the employer can demonstrat, that deconte,,un bon of such equipment or portions of such equipment as not feasible. (A) A readily observable label in accordance with paragraph (gIIINLUH) shall be attached to the equipment stat_ag which portions resn*tn cont.mmnted. ------- Federal Register I Vol. 56. No. 235 I Friday. December 6. 1991 I Rules and Regulations 64177 (B) employer shall ensure that this information is conveyed to all gflected employees, the servicing represent3ti and/or the manufacturer as approp1 8t . prior to handling. servicing. or shipping so that appropriate precautions wilJ be taken. (3) Personal protective eqwpmant—{i) Provision. When there is occupational e’cposure. the employer shall provide, at no cost to the employee. appropriate personal protective equipment such as. but not limited to. gloves, gowns. laboratory coats face shields or masks and eye protection, and mouthpieces. resuscitation bags. pocket masks, or other ventilation devices. Personal protective equipment will be considered ‘appropriate” only if it does not permit blood or other potentially infectious materials to pass through to or reach the employees work clothes, street clothes. undergarments. skin, eyes. mouth, or other mucous membranes under norm_ni conditions of use and for the duration of time which the protective equipment will be used (ii) Use. The employer shall ensure that the employee uses appropriate personal protective equipment unless the employer shows that the employee temporarily and briefly declined to use personal protective equipment when. under rare and extraordinary circumstances, it was the employee’, professional judgment that in the specific instance its use wouid have prevented the delivery of health care or public safety services or would have posed an increased hazard to the safety of the worker or co-worker. When the employee makes this judgement. the circumstances shall be investigated and documented in order to determine whether changes can be instituted to prevent such occurence , in the future. (:ii) Accessibility The employer shall ensure that appropriate personal protecut e ecuipinent in the appropriate size, is readiiy accessible at the worksite or is issued to employees. Hypoallergeruc gloves. glove hneh. powder(ess gloves. or other itmila _ r alternatives shall be readily accessible to those employees who are allergic to the glo%es normally provided (iv) Clear.ing, Laundering. and Disposal The employer shall clean. launder, and dispose of personal prote tite equipment required by Paragraph, (d) and (e) of this standard, at no cost to the employee. (v) Repair and Replacement. The employer shall repair or replace Personal protective equipment as needed to maintain its effectiveness, at no cost to the employee. (vi) l a garment(s) is penetrated by blood or oti’ier potentially infectious materials, the garment(s) shall be removed immediately or as soon as feasible (vu) All personal protective eqwpment shall be removed prior to leaving the work area (viii) When personal protective equipment is removed it shall be placed in an appropriately desigeated area or container for storage. washing. deconthmin tiou or disposaL (ix) Gloves. Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and non ’intact skin. when performing vascular access procedures except as specified in paragraph (d)(3)(ix)ID) and when h ‘ 1 ing or touching contaminated items or surfaces. (A) Disposable (single use) gloves such is surgical or exemlnat ion gloves. shall be replaced as soon as practical when contaminated or as soon U feasible If they are torn, punctured. or when their ability to function as a barrier is compromised. (B) Disposable (single use) gloves shall not be washed or decontaminated for ie use. (C) Utility gloves may be decontaminated for re-use if the integrity of the glove is not compromised. However, they must be discarded if they are cracked, peeling. torn, punctured, or exhibit other signs of deterioration or when their ability to function as a barrier is compromised (DJ If an employer in a volunteer blood donation center judges that routine gloving for all phlebotonues is not necessary then the employer shall. (1) Periodically reevaluate this policy: (2) Make gloves available to all employee, who wish to use them for phlebotomy: (3) Not discourage the use of glove, for phlebotomy: and (4) Require that gloves be used for phlebotomy in the following (1) When the employee has cuts. scratches, or other breaks in his or her ak (“1 When the employee judges that hand contamination with blood may occur, for example. when performing phlebotomy on an uncooperative source individuak and ( v i) When the employee is receiving training in phlebotomy. (x) Masks, Eye Protection. and Face Shields. Masks in combination with eye protection devices. such as goggles or glasses with solid side shields. or chin- length face scalds. shall be worn whenever splashes. spray, spatter. or droplets of blood or other potentially infectious materials may be generated and eye. nose, or mouth contamination can be reasonably anticipated. (x i) Gowns. Aprons, and Other Protective Body Clothing. Appropriate protective clothing such as. but not Limited to. gowns, aprons, lab coats. clinic jackets. or similar outer garments shall be worn in occupational exposure situations. The type and characteristics will depend upon the task and degree of exposure anticipated. (xii) Surgical caps or hoods and/or shoe covers or boots shall be worn in instances when gross contamination can reasonably be anticipated (e.g.. autopsies. orthopaedac surgery). (4) Housekeeping (,) General. Employers shall ensure that the worksite is maintained in a clean and sanitary conthnon. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area (ii) All equipment and environmental and working surfaces shall be cleaned and decontammated after contact with blood or other potentially infectious materials (A) Contaminated work surfaces shall be cecontaminated with an appropriate disinfectant after completion of prncedures immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials. and at the end of the work shaft if the surface may have become contaminated since the last cleaning. (B) Protective coverings, such as plastic wrap. aluminum foil, or imperviously-backed absorbent paper used to cover equipment and environmental surfaces. shall be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the workshzft if they may have become contaminated during the shaft. (C) All bins, pails, cans. and similar receptacles intended for reuse which have a reasonable likelihood for becoming contaminated wit’n blood or ocher potentially infectious materials shall be inspected and decontaminated on a regulany scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination. (Di Broken glassware which may be containin ted shall not be picked up directly with the hands. It shall be cleaned up using mechanical means. ------- 4178 Fader.! Register I VoL 58. No. 235 / Pridav . December 6. 1991 I Rules and Regulations such u a brush and dust pan. to . or forceps. (E) Reusable sharps that are contaminated with blood or other potentially infectious materials shall not be stored or processed in $ manner that requueS employees to reach by hand into the ccntainm where these sharps have been placed. (iii) Regulated Waste. (A) Can__ ted Sharps Discarding and Containment (2) Cont ,i ina ted sharps shall be discarded immediately or as SCCfl as feasible to containers that are: (/) aauble (ii) Punn resistant (ii:) Leakproof an sides and battonu and ( iv) Labeled or color.ccded in accordance with paragraph (g)(1)(i) of this standard. (2) Doing use. 000taine,i for cont2mm ted sharps shall be (I) Easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonabiy antiapated to be found (e.g.. laucdnes): (ii) Maintained upright throi out ussi and (ii:) Replaced routinely and not be allowed to uver l 13. (3) When moving containers of cont nninatad sharps from the area of use, the containers shall be (1) Closed immediately prior to removal or repIa . t to j vcflt spillage or prouuasion of contents during handling, storage. tiunspcrt. or shipping: (ii) Placed in a secondary container if leakage is possible. The second container ahafl be (A) Closable (B) Consu ’ucted to contain all contents und prevent leakage during handling . storage. Uanrport. or shipping: and (C) Labeled or color.coded according to pa.-agraph (gj(i)(i) of this standard. (4) Rnusable containers shall not be opened. emptied. or cleaned manually or In any other manner which would expose employees to the risk of perc ’Jtsneous m ury. (B) Other Rerulated Waste Ccnta!nment ,(7) Regulated waite shall be.p laced n containers which are’ (,) Closable: (i/) Consti,icted to contain all contents and prevent leakage of fluids during handling. storage. tiensport or shipping: (ii i) Labeled or color.coded si scuardance with parapaph (gXl)(I) this standardi and (iv) Closed prior to removal to pieent spillag, or protrusion of contents during handling. storage. transport, or shipping. (2) If outside nt.Mln.tion of the regulated waste container o s . It shall be placed to a second container. The second container shall be’ (1) Closable’ (ii) Constructed to contain all contents and pre t leakage of fluids during handling. storage. transport or shipping: (i ii) Labeled or color .coded in accordance with parapaph (g)(1)(f) of this standard: and (iv) Closed prior to removal to prcvunt spillage or pro usion of contents dw g h ndhng . storage. transport, or shipping. (C) Disposal of all regulated waste shall bern accordance with applicable regulations of the United Slates. Slates and Territories. and political subdivisions of States and Territories. (iv) Laundry. (A) Ctmt m ted lawu&y shall be handled as little as possible with a mtTnom ofagitation. (1) Contiu ii,ioted laundry shall bebagged or containerized at the location where it was used and shall not be sorted or rinsed in the location of use. (2) t Iinth!, uI ted laundry shall be placed and transported in bags or containers labeled or color.coded in accordance with paragraph (gJ(1)(i) of this standard. When a facility utilizes Universal Precautions in the handling of all soiled laundry. alternative labeling or color-coding Is sn urent lilt permits all employees to recognine the containers as requiring ca mp l ’ . ” , with Universal (3) Whenever cont m ted laundry Is wet and presents a reasonable likntthoo 4 of soak-through of or leakage from the bag or container, the laundry shall be placed end transported in bags or containers which prevent soak- through and/or leakage of fluids to the (B) The employer shall emure that employees who have contact with cont. ! in ted Laundry wear protective gloves and other u ,pnate personal protective equipment. (C) When a facility ships contaI,i,i ted laundry offitte to a second facility which does not utihee Universal Precautions in the h dling of all laundry. the facility generating the cont m ted laundry must place such launchym bags or containers which are labeled or color-coded to accordance with parsgrsph (gfllXI). (a) HlVondHBVResea,ch Lobozctcnes and Prothict. on FaciIit,.on (1) This paragraph applie, to research laboratories and production facilities engaged in the sulture. production. conomtratlon. experimentation, and mpuladen of 10V and ISV. It does not apply to H il I or diagnostic laboratories engaged solely to the analysis of blood, tissues. or organs. These r u. inents apply in addition to the other re us ments of the standard. (2) Research laboratories and production facilitie, shall meet the following erutena: (i) Standard microbiologicel practices. All regulated waste shall either be incinerated or decontaminated by a method such as autoclavurug keown to effectively destroy bloodborne pathogens. (11) Special practices. (A) Laboratory doors shall be kept closed when work involvuig IfiVor HBV Is in (B) Contaminated materials that are to be decont m ted at a site away from the work area shall be placed in a durable. &ealcproof. labeled or color- coded container that is closed before being removed from the work area. (C) A to the work area shall be limited to authorized persons. Written policies and procedures shall be established whereby only persons who have been advised of the potential biohazard. who meet any specific enoy req tmants. and who comply with all entry and esit procedures shall be allowed to enter the work areas sad •nti i I rooms. (D) When other potentially infectious ma ials or infected m Iu are present in the work area or cont 9in .,%t module. a hazard warning sign incorporating the universal biohazard symbol shall be posted on all access doors. The hazard warning sign shall comply with paragraph (gJ(lXll) of this (E) All activities involving other potentially Infectious materials shall be conducted in biological safety cabinets or other devices within the coet.i . lt module. No work with these other potentially infectious materials shall be conducted on the open ben (F) Laboratory coats. gowns. smocks. uniforms, or other a 4 ate protective clothing shall be used in the work area and rooms. Protective clothing shall not be worn outside of the work area and shall be decontaminated before being laundered. (G) Special care shall be taken to avoid skin contact with other potentially infectious materials. Gloves shall be worn when handling infected animals and when making hand contact with other potentially infectious materials Is unavoidable. (H) Before disposal all waste from work areas and from animal rooms shall sidisi be incinerated or by a method such as autoclaving own to effectively destroy bloodbosne pathogens. ------- Federal Register / Vol. 56. No. 235 I Friday. December 6. 1991 I Rules arid Regulations 64179 (I) Vacuum Lines shall be protected with liquid disinfectant traps and high- efficiency particulate air (} A) filters or filters of equivalent or superior efficiency and which are checked routinely and maintained or replaced as (J)Hypodermic needles and syringes shall be used only for parenteral irnection and aspiration of fluids from laboratory n,mgI . and diapbra bottles. Only needle-locking syringes or disposable syringe-needle units (i.e.. the needle in integiul to the syringe) shall be used for the injection or aspiration of other potentially infectious materials. Extreme caution shall be used when h i’ 4brig needles and syringes. A needle shall not be bent, sheared, replaced in the sheath or guard. or removed from the syringe following use The needle and syringe shall be promptly placed in a puscnure-resistant container and autoclaved or decontamt ated before reuse or disposal. ( IC ) All spills shall be immediately contained and cleaned up by appropriate professional staff or others properly trained and equipped to work with potentially concentrated infectious materials. (U A spill or aecident that results in in exposure incident shall be immediately reported to the laboratory director or other responsible person. (M) A bioufery mAT !I2l shall be prepared or adopted and periodically reviewed and updated at least annually or more often If necessary. Personnel shall be advised of potential hazards. shall be required to read Instructiots on practices and procedures. and shall be required to follow them. (uij Containment equ ipmenL (A) Certified biological safety cabinets (Class L I I. or UI) or other appropriate combinations of personal protection or physmnal containment devices, such as special protective clothing, respirators. centrifuge safety cups. sealed centrifuge rotor,, and containment caging for ‘ Ls . shall be used for all act1v1tie with other potentially infectious materials that pose a threat of exposure to droplets,, splashes. spills, or aerosols (B) Biological safety cabinets shall be certified when installed. whenever they are moved and at least annually (3) HIV and V research laboratories shall meet the following criter ia (i) Each laboratory shall contain a facility for hand washing and an eye wash facility which is readily available within the work area. (ii) An autoclave for decontamination of regulated waste shall be available. (4) MW and HBV production facilities shall meet the following ciiteria (1) The work areas shall be separated from areas that are open to unrestricted traffic flow within the building Passage through two sets of door, shall be the basic requirement far entry into the work area from acces, corridors or other contiguous areas. Physical separation of the high-containment work area from access corridors or other areas or activities may also be provided by a double-doored clothes-change room (showers may be meluded). airlock, or other access facility that requires passing through two sets of doors before entering the work area. (i i) The surfaces of doors. walls, floor, and ceilings in the work area shall be water resistant so that they can be easily cleaned. Penetrations in these surface, shall be sealed or capable of being sealed to facilitate deconta”t,na bon. (iii) Each work ares shall contain a sink for washing hands and a readily available eye wash facllity. The sink shill be foot, elbow, or automatically operated and shall be located near the exit door of the work area. (iv) Access doors to the work area or contain t module shall be self- closing. (v) An autoclave for decontamination of regulated waste shall be available wfthinoru near as possible to the work area. (vi) A ducted exhaust-air ventilation system shall be provided. This system shall oreate directional airflow that draws air into the work area through the anny area. The exhaust air shall not be recirculated to any other area of the building. shall be discharged to the outside, and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be verified (La.. into the work area). (5) Training Requirement,. Additional training requirements for employees in MW and HBV research laboratories and MW and I9V production facthtzes are specified in paragraph (g)(2)(ix). (0 Hepatitis B vaccznotion and post- exposure evaluation and fellow.up—(i) General (i) The employer shall make available the hepatitis B vaccine and vaccination series to all employees who have occupabons.l exposure, and post. exposure evaluation and follow-up to all employees who have had an exposure incident (ii) The employer shafl ensure that all medical evaluations and procedure, including the hepatitis B vaccine and vaccination series and poat-exposu_re evaluation and follow-op. including prophylaxis. are (A) Made available at no cost to the employesi (B) Made a ailable to the employee at a reasonable time and place. (C) Performed by or under the supervision of a licensed physician or by or under the supervision of another licensed healthcare professionaL and (D) Provided according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedure, take place. except as specified by this paragraph (I). (iii) The employer shall ensure that all laboratory tests are conducted by an acciedited laboratory at no cost to the employee. (2) Hepatitis B Vaccz,otion. (i) Hepatitis B vaccination shall be made available after the employee has received the training required in paragraph (g)(2)(vu)(I) and within 10 working days of initial assignment to all employees who have occupational exposure unless the employee has previously received the complete hepatitis B vaccination series, antibody testing has revealed that the employee is immune. or the vaccine is contraindicated for medical reasons. (L) The employer shall not make participation in a presoreening program a prerequisite far receiving hepatitis B vacumabon. (iii) If the employee initially declines hepatitis B vaccination but at a later date while still covered under the standard decides to accept the vionnanon, the employer shall make available hepatitis B vaccination at that time. (iv) The employer shall assure that employee, vho decline to accept hepatitis B vaccination offered by the employer sign the statement in appendix A. (v) If a routine booster dose(s) of hepatitis B vaccine is recommended by the U.S. Public Health Service at a future date, such booster dose(s) shall be made available in accordance with section (f)(1)(u) (3) Pbst-expasure Eraluat,on and Follow-up Following a report of an exposure incident. the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow-up. including at least the following elements (I) Documentation of the route(s) of exposure, and the circumstance, under which the exposure incident occurredi (ii) Identification and documentation of the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law (A) The source individual’s blood shall be tested as soon as feasible and ------- g gj Federal Register I Vol. 56. No. 235 I Friday. December 6. 1991 / Rules and Rvoulations after consent is obtained in order to determine F V and H1V infectivity. If consent is not obtained, the employer shall establish that legally required consent cannot be obtained. When the source individual’s consent is not required by law, the source individuals blood. if available, shall be tested and the results documented. (B) When the source individual is already known to be infected with HBV or } ‘V, testing for the source individual’, known I V or }flV states need act be repeated. (C) Results of the source individual’, testing shall be made available to the exposea employee. and the employee shall be informed of applicable laws and regulations concerning disclosure of the identity and nfectious status of the source individual. (iii) Collection and testing of blood for HBV and J’CV serological status (A) The exposed employee’s blood shall be collected as soon as feasible and tasted after consent is obtained. (B) If the employee consents to baseline Wood collection, but does not give consent at that time for M W serologic tasting. the sample shall be preserved for at least 90 days. If. wtthan ao days of the exposure incident, the employee elects to have the baseline sample tested. such testing shall be done as soon as feasible. (iv) Post-exposure prophyjaxis, when medically indicated,., recommended by the U.S. Public Health Service (v) Counselingi and ( vi) Evaluation of reported illnties . (4) Lrxformotion Provided to the Heolthcn,e ProfessionaL (I) The employer shall ensure that the healthcare professional responsible for the employee’s Hepatitis B vaccination is provided a copy of this regulation. (ii) The employer shall ensure that the healthcare professzo al evaluating an employee after an ex os incident is provided the following information: (A) A copy of this regulation, (B) A desoription of the exposed employees duties as they relate to the exposure incident (C) Documentation of the route(s) of exposure and ci stance , der which exposure occigred. (D) Results of the source individual’, blood testing. if available. and fE) All medical records relevant to the appropriate nea ent of the employee u ’.clud ing vaccination status which axe the employers respousibthty to ciamlain. (5) Heclthcore Professional’s Written Opinwa. The employer shall obtain and provide the employee with a copy of the eveluatii 4 healthcare professional’, written opinion within IS days of the completion of the evaluation. (i) The healthcaie professional’, written opinion for Hepatitis B vaccination shall be limited to whether Hepatitis B vaccination is indicated for an employee, and if the employee has received such vaccination. (ii) The healthcare professional’s written opinion for post-exposure evaluation and follow-up shall be limited to the following information: (A) That the employee has been informed of the results of the evaluation: and (B) That the employee has been told about any medical conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or tiea ent. (iu) All other findings or diagnoses shall r am confidential and shall not be included in the written report. (6) Medical zecozdkeepmg. Medical records reqaired by this standard shall be maintained in accordance with para apb (hfli) of this section. (g) Communication of hazwds to employee,— (I) Labels and signs (I) Labels. (A) Warning labels shall be a,thxed to containers of regulated wute, refrigerators and freezers contamrng blood or other potentially infectious material: and other containers used to store. ti’,nsport or ship blood or other potentially infectious materials, except as provided in paru?eph (g)(1)(i)(E). (F) and (C). (B) Labels requrred by this section shall include the following legend: WOHAz RD (C) These labels shall be fluorescent orange or orange-red or predo”tantly so. with lettering or symbols in a cononsting color. (D) Labels required by a xed as close as feasible to the container by sting, wire, adhesive, or other method that prevents thai lou or unintentional removal. (E) Red bags or red container, may be substituted for labels. (F) Containers of blood, blood components, or blood products that are labeled u to their contents and have been released for ti’ansfusion or othsr clinical use are exempted from the labeling requirements of p.r*gieph (g) (C) Individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage. uensport. shipment or disposal are exempted from the labeling req ement , (H) Labels required for conteminated equipment shall be in accordance with this para aph and shall also state which portions of the equipment remain cont amm ted. (I) Regulated waste that has been decontam ted need not be labeled or color-coded. (ii) Signs (A) The employer shall post signs at the ennence to work areas specified in paragieph (e). MW and HBV Research Laboratory and Production Facilities, which shall bear the following BIOE .ZARD BIOHAZARD (Nans of the Infectious Agmt) (Special ieq ent (or ent.nn the area) (Nuns. talephuna nienber of the tsborstoxy dasou or other vssp sxble person.) (B) These signs shall be fluorescent orange -red or predoiv m ntly so. with Lettenag or symbols in a contesting color. (2) lnf oneouon and Trnzni g. (1) Employers shall ensure that all employees with occupational exposure participate in a taming program which must be provided at no cost to the emoloyee and during working hours. (ml) Training shall be provided as foilowe: (A) At the time of initial assignment to tasks where occupational exposure may take place (B) Within 90 days after the effective date of the standard: and (C) At least annually thereafter. (iii) Far employees who have received taming on bloodhorne pathogens in the year preceding the effective date of the standard, only fr m,Iig with respect to the provisions of the standard which ware not included need be provided. (iv) Annul taming for all employees shall be provided within one year of their previous t .I m1 ------- Federal Register / Vol 56 No. 235 / Friday. December 6. 1991 I Rules and Regulations (v) Employer, shall provide additional tiaining when shanges such as modification of tasks or procedures or t stituDofl of sew tasks or procedures affect the employee, occupational ecpoaure. The additional training may be limited to addressing the new e’ posuees meated. (vi) Material appropriate in content and vocabulary to educational leveL literacy, and language of employees sb iall be used. (vii) The training program shall contain at a mimum the following e!ementsi (A) Anaccessible copy of the regulatory text of this standard and an e’cplanation of its contents: (B) A general explanation of the eptdemiolo ’ and symptoms of bloodborne diseases: (C) An explanation of the modes of transmission of bloodhorne pathogenn (D) An explanation of the employer’s exposure control plan and the means by which the employee can obtain $ copy of the wr tt lani (E) An explanation of the aporopriate methods for recognimng tasks and other actaslbes that may involve exposure to blood and other potentially infectious matenalg (F) An explanation of the use and limitations of methods that will prevent or reduce exposure including appropriate engineering controls, work practices, and personal protecti ’e equipment (C) Information on the types. proper use. Location, removal, handling . decontn,nznstion and disposal of personal protective eqnipment (H) An explanation of the basis for se lec tion of personal protective eqwpme n (I) Information on the hepatitis B vaccine, including information on its efflcac . safety. methcd of acu isu’euon, the beni fi ., fbauig .accina(en, and thai tLe va ne and viccinzbon will be offered tree of cltarge: U) lniormc cn on the appropriate actor.s to take and persona to cor. act in an eme aency Ln olving blood or other potentially infectious materiaL,. ( Xl An expianation of the procedure to foiow if an ex’osure incident occurs. uicludw.g the method of repor ing the incident and the edical foUo ’up that will be made available: I L) !nIormat on on the post-exposure evaluation and follow-up that the employer is requ - to pro ’ ’ide for the employee following an exposure incident (M) An expLar.ation of the signs arid labe ls and/or color coding required by paragraph (g)(i) and (N) An opportunity for interactive questions and answers with the person cor.ducting the training session. (viii) The person conducting the trairung shall be knowledgeable in the sub;ect matter covered by the elements contained in the training program as it relates to the workplace that the training will address (ix) Additional Initial Training for Employees in MW and HBV Laboratories and Production Facilities Employees in l ’BV or ) ‘ V research laboratories and l ’UV or 11EV production facilities shall receive the following initial training in addition to the above training requirements. (A) The .mp oyer shall assure that employees demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV or 11EV. (B) The employer shall assure that employees have prior experience in the handling of human pathogens or tissue cultures before working with HIV or 1 V. (C) The employer shall provide a training program to employees who have no prior experience in h ndhrig human pathogen.. Initial work activities shall not include the handling of infectious agents. A progression of work acbv i es snaIl be assigned as techniques are learned and proficiency is developed. The employer shall assure that employees participate in work activ’.ties involving infectious agents only after proficiency has been demonstrated, (h) Recordkeep.:.’rg—(z) .‘ (ethca/ Records. (I) The employer shall establish an maintain an accurate record for each employee with occupational exposure, in accordance with 29 CFR 19rn29. (:i) This record shall include: (A; The name and social seciiri’y n.imoer c’ the epli, cc (B) A copy of the emplc ee s hepat.us B vaccination s:atus inc ndng the dates of all the hepatitis B vacunations and any medicai records rela ve to the emoioyee $ abiLty to rece ve vac:ina n as required cy paragraph (fl j tC) A coov of all reo t, cf examinations, mecica! testing. and futlow-up procedures as required ‘cy paragraph U (3): (Dl The emoloyar s copy of the healthcare professionals written opinion as required by paregrape (fl(5 1. and (E) A copy of the information provided to the healthwe professional as required by paragraphs (f)(4)(ii)(B)(C) and (D). (iii) Confidentiality The employer shall ensure that employee medical records required by paragraph (h)(t) are’ (A) Kept confidentiaL and (B) Are not disclosed or reported without the employee s express written consent to any person within or outside the workplace except as required by this section or as may be required by law. (iv) The employer shall maintain the records required by paragraph (h) for at least the duration of employment plus 30 years in accordance with 29 CFR 1910,29. (2) Tro:.iing Records. (ii T.-czn:oy records shc!I include the following rnformctwr (A) The dates of the training sessions’ (B) The contents or a summary of the training sessions. (Cyrhe names and qualifications of persons conducting the training and (Di The names and job titles of all persons att.’ding the training sessions. (ii) Training records shall be maintained for 3 years from the date on which the training occurred. (3) Avnilobsthy. (I) Ibe employer shall ensure that all records required to be maintained by this section shall be made available upon request to the Assistant Secretary and the Director for er i I I.tion and copying. (ii) Employee training records required by this paragraph shall be provided upon request for exkmIr . tion and copying to employees, to employee representatives, to the Director. and to the Assistant Secretary in accordance with 29 ‘R i io.m ( Ii :) Employee medical records required by this paragrsph shall be provided upon request tar exn n1nR don and copying to the subject employee, to anyone having written consent of the subject employee, to the Director and to the Assistant Secretary in accordance w:th 29 CFR 1910_29 (..) T.’arsfer of Records (‘) The employer shall compl) with the requirements involving transfer of records set forth in 29 1910.29th) (i.) 11 the employer ceases to do business and there :s no successor employer to recetve and retain the records for the prescribed period, the employer shall notify the Director. at leas: thiet months prior to their disposal and transmit them to the Director. if required by the Director to co so. within that t ee month period. (i) Dates—fl) Effective Date The standard shall become e ecDve on March 6. 1992, (j The E.*posure Control Plan required by paragraph (c)12) of this section shall be completed on or before May 5. 1992. ------- 64182 Federal Register / Vol. 56. N3. 235 I Friday. December 6. 1991 I Rules and Reg i1ations (3) Paraçaph (g)(2) Information and Training and (hi Recordkeeping shall take effect an or before june 4. 1992. (4) Paragraphs (d)(2) En neertag and Work Practice Con ols. (d)(3) Personal Protective Eçwptner.t. (d)(4) Housekeeping. (e) IUV and I V Reeeaxch Laboratones and Frodtictian FacilIties. (fl Hepatitis B Vaccination and Post-Expasore Evaluation and Follow-up, and (g) (1) Labels and S: s. shall take effect juy 6.1992. Appendix A to Sc o 1110 313O—Hspaa a B Va (Mandatory) I onderstand that nn to y op. oaaI v a e to blood or othor potentta 1y infections inaterials I inay be at tak of $ 4 ..M.4 hepatitis B vwius (I t) infection. I have been ven the opportunty to be vacunazsd with hepatitis B at no sip to inywlL Huwwv . I dedine bapatina B vac nation at this tine I cndeinsnd that by declining Lbs vac n* I continue to be at n ih of sc utnng hepatitis B. a serous oiuue. If in the future I continue to have owational exposure to blood or other potentially infectious materials and I want to be vaccinated with hepatitis 3 vae. I cen receive the vaccination series at no thar e to ma [ FR Dcc. 9I- M6 Filed U--9t &43 anl eeI onni ř ------- APPENDIX B ------- APPENDIX B EXPOSURE INCIDENT AND TREATMENT PACKET ------- EXPOSURE INCIDENT RECORD FOR BLOODBORNE PATHOGEN EXPOSURE EMPLOYEE INSTRUCTIONS You are completing this form because you have experienced an actual or a potential exposure to blood or other potentially infectious material. An evaluation of this exposure is required by the Bloodborne Pathogen Standard of the Occupational Safety and Health Administration. Please complete all the information below. Take this form with you when you go to a physician or other health care provider for the evaluation of the exposure. The information contained on this form is crucial to a proper evaluation of the exposure. Please take the time and care in completing the form to insure that the information is clear and accurate. If you need information on where to have this medical evaluation performed, please contact your supervisor. The medical evaluation for a suspected exposure to blood or other potentially infectious material should be done soon as possible after the exposure. The effectiveness of certain vaccines or other medication which might prevent any illness resulting from these exposures is greatest if given shortly after the exposure. Complete the appropriate accident report for your supervisor. Page 1 of 6 ------- EMPLOYEE’S STATEMENT: (PLEASE PRINT) A. Employee Identification. Name: _______________________________________ Social Security Number: _________________ Job Title: ____________________________ Work Location: __________________________ Work Phone: _____________________________ Supervisor: ________________________________ B. Description of Exposure Incident. Date: ___________ Time: _______ am/pm (circle one) City/Town: _____________________ State: ______________ Describe Incident (Please include the type of infectious material to which you were exposed and the circumstances of the exposure): Page 2 of 6 ------- SUPERVISOR’S STATEMENT: (PLEASE PRINT) Employee’s Name: A. Supervisor Identification. Name: _______________________________________ Work Phone: ______________________________ B. Description of Incident Please describe the employee’s duties as they relate to the exposure incident: C. Hepatitis B Status The employee named above 0 has /0 has not received a three dose series of Hepatitis B Vaccine. If yes, the series was completed on __________ (date). D. Investigation of Source Please describe what information is known about the source (person) of the exposure (especially name, address, telephone number, or other contact point), the result(s) of the blood testing of the source (if known), or why blood testing of the source is not feasible. Also, if the source is known to have or test positive for Hepatitis B or Human Immunodeficiency Virus (HIV), please indicate this fact. The OSHA standard requires that the source be tested for these agents unless such testing is not legally possible. Page 3 of 6 ------- EXPOSURE INCIDENT RECORD FOR BLOODBORNE PATHOGEN EXPOSURE HEALTH CARE PROVIDER INSTRUCTIONS This employee is being referred for your evaluation of an exposure incident to blood or another potentially infectious material. This referral is to be performed under the provisions of the OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030). A copy of this standard is attached. Several items included in the OSHA standard deserve your close attention. • Under the OSHA standard, the following bodily fluids are considered potentially infectious: blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva (in dental procedures), and any body fluid visibly contaminated with blood. • The exposed employee’s blood should be collected as soon as feasible after consent is obtained and tested for HBV and HIV status. • If the employee gives consent for baseline blood collection, but does not give consent for HIV serological testing at the time of collection, the blood sample should be stored for 90 days. If within 90 days of the exposure incident, the employee elects that the baseline sample be tested, such testing should be performed. • Post-exposure prophylaxis is to be given according to the guidelines of the U.S. Public Health Service, which are attached. Optimal use of these recommendations requires knowledge of the HBV status of the source and the exposed individual. • OSHA requires that you submit a report of the post-exposure evaluation. A form for this purpose is attached. Page 4 of 6 ------- EXPOSURE INCIDENT RECORD FOR BLOODBORNE PATHOGEN EXPOSURE HEALTH CARE PROVIDER REPORT OF POST-EXPOSURE EVALUATION Employee name: Date of office visit: __________________________________________ Health Care Facility Address: _________________________________ Health Care Facility Telephone: _______________________________ As required under the OSHA Bloodborne Pathogen Standard: o The employee named above has been informed of the results of the post-exposure medical evaluation. O The employee named above has been told about any medical conditions resulting from exposure to blood or other potentially infections materials which require further evaluation or treatment. (Printed Or Typed Name of Health Care Provider) (Signature of Health Care Provider) (Date of Signature) Page 5 of 6 ------- Treatment Protocol Table. Recommendations for hepatitis B prophylaxis following exposure incident) Trea nent when source Is found to be Exposed person HBsAG po bve HBSAG nega ve Unknown or not tested unyaccinated Administer HB!G x 1 and initiate Initiate hepatitis B nitiate hepatitis B vaccine’ hepatitis B vaccine’ vaccine’ Previously vaccinated known responder Test exposed person for No treatment No treatment ar iti-HBs 1 II adequate, no treatment 2 Il inadequate, hepatitis B vaccine booster dose Known non-responder HBIG x 2 or HBIG x 1, pIus 1 No treatment No treatment dose of hepatitis B vaccine Response unknown Test exposed person for anti-HB’ No treatment Test exposed person for anti-HBs 1 If inadecuate HBIG x 1, pIus 1 If inadequate, hepatitis B hepatitis B vaccine booster vaccine booster dcse dose 2 If adecuate, no treatment 2 Il adecuate, no treatment riepatitis B immune giooulin (HBIG) dose 006 mI/kg intramuscu arIy - -lepatitis B vaccine cose—see Table 1 Adequate anti-HBs is 10 millt-internationai unrts U.S. Public Health Servtce, Center for Disease Control, Morbidity and Mortality Weekly , November 22, 1991, 40:(RR-13) 22. Page 6 of 6 ------- APPENDIX C ------- APPENDIX C HEPATITIS B VACCINATION INFORMATION AND CONSENT/DECLINATION FORMS ------- NEIC Exposure Control Plan Bloodborne Pathogen Exposures Page 1 Appendix C. Hepatitis Vaccination Information and Consent/Declination Forms APPENDIX C HEPATITIS B VACCINATION INFORMATION AND CONSENT/DECLINATION FORMS NEIC offers free vaccinations against Hepatitis B virus for all employees who are at increased risk for bloodborne pathogens (BBP) at work. Employees are at increased risk and should consider vaccination if they (1) have direct contact with human blood or other body tissues or (2) are at risk of trauma, needle sticks, cuts, or abrasions that may result in percutaneous exposure to materials infected with Hepatitis B virus. The Disease Hepatitis B, formerly called serum , hepatitis is a disease caused by the Hepatitis B virus (HBV). There is no specific treatment for Hepatitis B infection other than supportive measures. Most persons who become infected with Hepatitis B recover completely and are immune to subsequent exposures. However, of all those who develop Hepatitis B infection, about 0.1% die of fulminating hepatitis. The prognosis depends on age, dose, and severity of underlying disease. Five to 10% of cases become chronic lifetime carriers who are capable of transmitting the disease to others and are at risk of developing chronic active Hepatitis B, cirrhosis (2%) or liver cancer (0.4%). Risks of Hepatitis B Infection for Health Care Workers Health care workers who have contact with blood, infected tissue or secretions, and regular exposure to trauma, needle sticks, cuts, and abrasions are most at risk for acquiring Hepatitis B. In the United States, about 5% of the general population show evidence of past or present Hepatitis B infection, while up to 30% or more health care workers in high risk areas show evidence of past Hepatitis B infection. The Vaccine A genetically engineered Hepatitis B vaccine was first licensed by the Food and Drug Administration in July of 1986. Genetically engineered vaccine is the vaccine offered to NEIC employees. The ------- NEIC Exposure Control Plan loodborne Pathogen Exposures Page 2 Appendix C: Hepatitis B Vaccination Information and Consent/Declination Forms vaccine, referred to as recombinant HB vaccine, (“Recoinbivax HB”, or “Engerix—B”) is very comparable, immunologically, to the earlier “Heptovax B” vaccine which was introduced in 1981. The difference between the two vaccines relates to their methods of derivation. Recombinant HB vaccine is genetically engineered from common baker’s yeast into which a plasmid containing the gene for the Hepatitis B surface antigen (HBsAg) and has been inserted. The first available plasma derived Hepatitis B vaccine (“Heptovax B”) is derived from highly purified plasma of chronic HBV carriers and then inactivated so that it is not infectious. The plasma derived vaccine is no longer produced in the United States. The full vaccination series for Hepatitis B includes an initial vaccination followed by repeat doses one month and six months later. Over 95 percent of susceptible healthy adults (20-39 years of age) who receive the full vaccination series achieve high levels (titers) of Hepatitis B surface antibody (anti-HBs) and are considered to be immune from Hepatitis B infection. The vaccine produces somewhat lower antibody responses in older adults than in younger adults. The dose is lOLg (1 ml) injected into the deltoid muscle. There is no evidence that the vaccine has ever caused Hepatitis B. Administration of the vaccine to persons already positive has no effect, good or bad. Administration of Hepatitis B hyper-immune globulin (HBIG) given prophylactically does not interfere with the development of antibodies to the vaccine. Persons already incubating Hepatitis B prior to receiving the vaccine may go on to develop clinical hepatitis in spite of the immunization although the vaccination may reduce the severity of the illness. Vaccine Risks and Possible Side Effects The incidence of side effects is very low, usually limited to soreness at the injection site, and mild systemic symptoms (fever, headache, fatigue, and nausea). There is no dancer of acauiring any blood borne disease from the Hepatitis B vaccine Itself . Early concerns about safety of plasma-derived HB vaccine (no longer in use here), especially the concern that infectious agents such as human immunodeficiency virus (HIV) present in donor plasma pools might contaminate the final product, have proven to be unfounded. The recombinant HB vaccine does not contain infectious materials. ------- NEIC Exposure Control Plan. Bloodborne Pathogen Exposures Page 3 Appendix C Hepatitis B Vaccination Information and Consent/Declination Forms post vaccination antibody testin for immune response it is currently recommended that titers of anti—HBs (Hepatitis B antibody) be tested 1-2 months after the completion of the full vaccination series for Hepatitis B. Those with a positive antibody titer* (i.e., a titer of 10 inilli—internationa]. units per milliliter of blood) at that time are considered to be immune. It is not known how long this immunity will last but the current thinking is that immunity will last for at least five to seven years and may be lifelong. At this time, the CDC is not recommending any booster shots for these and it is hoped that this immunity will be permanent. Further data on the need for booster shots may be available in coming years. Individuals who have a low antibody titer when tested (i.e., < 10 MIU/ml) 1-2 months after completion of the full vaccination series should receive further vaccinations and testing as noted below: They should receive a fourth injection (at the same dose as the original injection) just after the negative test results are received, and 1-2 months later should be tested again for ariti—HBs titers. If the titers are positive, the person should be considered immune. If the titers are still low, a fifth vaccination should be given at that time and anti-HBs titers tested once more 1-2 months later. If these titers are positive, the individual is considered immune. If antibody titers remain low after five injections, it is presumed the individual will not be able to develop an immune response and no further injections are indicated. In these cases the individual is considered a non—responder to Hepatitis B vaccinations and a physician should be consulted regarding the need for medical work restrictions. ------- NEIC Exposure Control Plan: Bloodborne Pathogen Exposures Page 4 Appendix C: Hepatitis B Vaccination Information and Consent/Declination Forms HEPATITIS B VACCINATION: CONSENT FORM I have read the information about Hepatitis B and the Hepatitis B vaccine. have had the opportunity to ask questions and understand the benefits and risks of Hepatitis B immunization. I agree to receive the three doses required for the optimum immune response. However, as with all medical treatment, I understand there is no guarantee that I will become immune or that I will not experience adverse side effects from the vaccine. Please print. Name of person to receive vaccine Social Security Number Signature of person receiving vaccine Witness Date Date HEPATITIS B VACCINATION RECORD 1 DATE GIVEN BY LOT # Primary dose 1 Month after Primary Dose 6 Months after Primary Dose HEPATITIS B VACCINATION: DECLINATION FORM I understand that, due to my occupational exposure to blood or other potentially infectious materials, I may be at risk of acquiring Hepatitis B virus (H.BV) infection. I have been given the opportunity to be vaccinated with Hepatitis B vad ine, at no cost to me. However, I decline Hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring Hepatitis B, a serious disease. If in the future I continue to have occupational exposure to blood or other potentially infectious materials and I want to be vaccinated with Hepatitis B vaccine, I can receive the vaccination series at no cost t me. Print Name Signature Social Security Number Address Date City/State ------- APPENDIX D ------- APPENDIX D REFERENCE INFORMATION ON HEPATITIS B INFECTIONS FROM MMWR ------- MMWR CEMEPS FOP DISEASE CONIROL Novembe, 22 1991 1 Vol 401 No AR 13 Ih. Mo.bsthiy and Mos#ahy W..Aly A.po 1 1MM WA I Sails. Is p.sp..ad by lb. Cent.,. to, Dls..s. Contiol md Is •wall.bl . on • puld ,ubsc.lpIIon basis horn lb. Supe.lnlend.nI of Docum.njs US and Recommendations Goi...nrnent Punting OllI ce. Washington OC 30402 islephon. 11021 Il) 3231 ha dii. In the weakly MMWR a,s piovislon.) basso on *eakly sports to COC by slat. ha.Iih Reports d.p.sirnmta Hi. uepo ,tlng weak conctudsa .1 close of business on Filday cornpll.d data one n allon.l basis as. ollklaly ,ets.,sd to th, public on the succeeding Filday Inquliles aboul the MMWA Sari,. Including n ,ala,Ial to ha cois,kfa..d I.. piubItcallois, should be dkscted to Eutlto,. MMWA Sails,. Medstop C Cs Cents,, to, Disc... Contiol Atlant, Ga 30333 I.I.jIhOne 404) 332 MORBIDI1Y AND MORIALIIY WEEKLY REPORI U S Oova,nrnsnl P,lnhInp 0*1k. 1112 I II 121141041 R.glon IV I I Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the z I United States Through Universal 5 , . Childhood Vaccination Recommendations of the Immunization Practices Advisory Committee (ACIP) a I 1 I I ‘ I I I U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES I .• Public Health Service 4 Centess for Disease Control / j I I I National Center for Inlect,ous Diseaces I I Atlanta. Georgia 30333 ------- I I MMWJ I Nowemb,, 22. 1991 Vol 40 I No RR- 13 MMWR 1 Immunization Practices Advisory Committee Membership LIst. September 1991 EXECUTIVE SECRETARY Claire V Broome. M 0 Centers for Disease Control MEMBERS Stanley E Broadnax. M D Cincinnati Health Department Mary Lou Clement.. M D Johns Hopkins University (Baltimore. Maryland) David W. Fraser, M V Swaithniore College (Pennsylvania) Carotine B Hall, M 0 University of Rochester School of Medicine and Dentiatry (New York) Carlos H Ramiiez Ronda. M 0 University of Puerto Rico School of Medicine (San Juan) Mary E Wilson. M 0 Mount Auburn Hospital (Cambridge. Massachusetts) Canadian National Advisory Committee on Immunization Susan E Tamblyn, M 0. Dr P H Stratford. Ontario Canada Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination Recommendations of the Immunization Practices Advisory Committee (ACIP) The following statement updates all previous recommendations on psotec- hon against hepatitis B virus infection, including use of hepatitis B vaccine and hepatitis B immune globulin for prophylaxis against hepatitis B virus infection (MMWR I 985.34 313 24.329-35, MMWR 7987,36 353 66, and MMWR 1990.39 INo R n 2! 8 79) and universal SC O8flifl9 of pregnant women to prevent pen- natal hepatitis B virus transmission (MMWR I 988.37 347 46,51. and MMWR 1990,39INo RR-2! 8- 79! Recommendations concerning the prevention of of her types of vua hepatitis are found in MMWR 1990,39(No RR 2! 1 8, 22-26 This document provides the rationale for a comprehensive strategy to eliminate transmission of hepatitis B virus in the United States This prevention strategy includes making hepatitis B vaccine a part of routine vaccination schedules for all infants INTRODUCTION The acute and chronic consequences of hepatitis B virus (HBV) infection are niaior health problems in the United States The reported incidence of acute hepatitis B increased by 37% from 1979 to 1989, and an estimated 200.000 300.000 now Infections occurred annually during t he period 1980—1991 The estimated 1 million- 1 25 million persons with chronic HBV infection in the United States are potentially infectious to others In addition, many chronically infected persons are at risk of long term sequelae, such as chronic liver disease and primary hepolocellular carcinoma, each year approximately 4.000-5.000 of these persons die from chronic liver disease (I) Immunization with hepatitis B vaccine is the most elleclive means of proveiiliiig HBV infection and Its consequences in the United States, most infections occur among adults and adolescents (2,3) The recommended strategy for preventing these infections has been the seleclive vaccination of persons wiih ideritilied risk factors (1,2) However, this strategy has not lowered the incidence of hepatitis B primarily because vaccinating persons engaged in high-risk behaviors, life styles, or occupa- tions before they become infected generally has not been feasible In addition, many infecied persons have no identifiable source for their infections and thus cannot be targeted for vaccination (2) Preventing IIBV transmission during eoriy childhood is irnpoilamit because of the high liketihood of chronic HBV imifectiori and chronic liver disease that occurs when children less luau 5 years of age become infected (3) Testing to identity pregnant CHAIRMAN Samuel I, Katz. M D Duke University Medical Center iames 0 Cherry. M 0 University of California School of Medicine (Los Angeles) EX OFFICIO MEMBERS John La Montagne. Ph 0 Nstional Institutes of Health Carolyn Hardegree. M D Food and rug Administration LIAISON REPRESENTATIVES American Academy of Family Physicians Ronald C Van Bureri, M 0 Columbus. Ohio American Academy of Pediatrics Georges Peter, M 0 Providence, Rhode island Caroline 8 HaIl, M 0 Rochester, New York American College of Physicians Pierce Gardner, M D Stonybrook. New York American Hospital Association William Schaffner, M 0 Nashville, Tennessee American Medical Association Edward A Morlime,, Jr. M 0 Cleveland. Ohio Carlos E Hernandez. M 0 Kentucky Department for Health Services Gregory H Istre. M D Medical City Hospital (Dallas, Texas) Department of Defense Michael Peterson, DV M MPH,Or PH Wasliiiigton. 0 C National Vaccine Program Kenneth J Ban. M V Rockville, Maryland •Terms oinpired 6130/91 ------- Nov.mber 22. 1991 MMWR The MMWR series of publications is publishod by the Epidemiology Program Office, Centers foe Disease Control. Public HealIli Service. U S Department of Health and Human Services. Atlanta, Georgia 30333 Centers for Disease Control William I Roper. M 0. M P H Director The recoiiimendatlons on hepatitis B virus ware developed by the Immunization Practices Advisory CommIttee (ACIPI. in collaboration with National Center lot Infectious Diseases James M Hughes, M D Acting Director Division of Viral and Rlckettsial Diseases Brian W J Mahy. Ph 0, Sc 0 Director HepatitIs Branch Harold S Margolis, M 0 Chief The production of this report as en MMWA serial publication was coordinated in Epidemiology Progmein Office Slephen B Thacker, M 0. M Sc Director Richard A Goodman, M 0, M P H Editor; MMWR Series Scieniillc CommunIcations Program Public Health Publications Branch Ava W Navin. M A Project Editor Ruth C Greenberg Editorial Assrstant Contents Introduction Epidemiology and Prevention of Hepatitis B Virus Infection Infections among Infants and Children Infections among Adolescents and Adults Epidemiology and Prevention of hepatitis Delia Virus Inlectioii Strategy to Eliminate Hepatitis B Virus Transmtssion Prophyla is against Hepatitis B Inlection Hepatitis B Immune Globulin Hepatitis B Vaccine Vaccine Usage Vaccine Efficacy and Booster Doses Vaccine Side Effects and Adverse Reactions Recommendations Prevention of Perinatal Hepatitis B Virus tnfection Universal Vaccination of Infants Born to HHsA 9 Negative Mothers Vaccination of Adolescents Vaccination of Selected High Risk Groups EvolvIng Issues in Hepatitis B Immunization Programs References Appendix Postexposure Prophylaxis for Hepatitis B Introduction Acute Exposure to Blood that Contains (or Might Contain) HBsAg Sea Partnere of Persons with Acute Ilepatitis B Virus Infection Household Contacts of Persons with Acute Hepatitis B Virus liifection SUGGESTED CITATION Centers (or DIsease Control Hepatitis B virus a comprehensive strategy (or elimInating transmissIon In the United Slates through universal childhood vaccination recommendattons of the Immunization Practices Advisory Commit- tee (ACIP) MMWR 1991 40(No RA 13) linciusive pa4e numbers) 2 2 3 4 4 5 5 5 6 9 10 11 11 13 13 14 16 16 21 21 21 24 24 Suzanne M Hewitt Chief Use of trade names is for identification only and does not imply endorsement by Pie Public Health Service or the U S Oeparlmeiit of Health and Human Services Copies can be purchased from Superintendent of Documents. U S Government Printing Office. Washington. DC 20402 9325 Telephone (202) 783 3238 ------- 2 MMWR Nov,nib., 22. 1991 Vol 401 No 11 1 113 MMWR 3 women who are hepatitis B surface antigen(HBsA 9 ) positive and providing their infants with Immunoprophylaxis effectively prevents HBV transmission during the perinalal period (4,5) Integrating hepatitis B vaccine into Childhood vaccination schedules in populations with high rates of childhood infection (e g , Alaskan Natives and Pacilic Islanders) has been shown to interrupt IIBV transmission (6) This document provides the rationale for a comprehensive strategy to eliminate transmission of HBV and ultimately reduce the incidence of hepatitis B and hepatitis U-associated chronic liver disease in the United States The recommendations for Implementing this str.legy include making hepatlhis B vaccine a part of routine vaccination schedules (or infants EPIDEMIOLOGY AND PREVENTION OF HEPATITIS B VIRUS INFECTION Infection, among Infants and Children In the United States, children become infected with HBV through a variety of means The risk of perinatai HBV infection among infants born to HBV-infected mothers ranges from 10% to 85%, depending on each mother’s hepatitis U e antigen (HBeAg) status (3.7,8) Infants who become infected by perinetal transmission have a 90% risk of chronic infection, and up to 25% will die of chronic liver disease a. adults 191 Even when not infected during the perinatat period, children of HBV-infected mothers remain at high risk of acquiring chronic HOV infection by person to-person (horizontal) transmission during the first 5 years of life (90) More than 90% of these infections can be prevented if HBsA 9 positive mothers are identrlied so that their infants can receive hepatitis B vaccine and hepatitis B immune globulin (HBiG) soon alter birth (4,5) Because screening selected pregnant women for HBaAg has failed to identify a high proportion of HBV-infocted mothers (11.92). prenatal HB8Ag testing of all pregnant women Is now recommended (1, I 3.941 Universal prenatal testing would Identify an estimated 22,000 1-IBeAg positive women end could prevent at least 6,000 chronic NOV Infections annually (3) Screening and vaccination programs for women and infants receiving care in the public sector have already been initiated through state immunization projects Horizontal transmission of NOV during lIre first 5 years of tile occurs frequently in populations in which HOV infection is endemic The risk of chronic infection is age dependeni. ranging from 30% to 60% for children 1-5 years of age (15) Worldwide, it has been recommended that, in populations in which HBV infection is acquired during childhood, hepatitis B vaccine should be integrated into routine vaccination schedules (or infants, usually as a part of the World Health Organization’s Expanded Programme on Immunization (16) in the United States, racial/ethnic groups shown to have high rates of childhood NOV infection include Alaskan Natives (6,97). Pacific Islanders (18). and infants of first generation immigrant mothers from parts of the world whole NOV infection is eiidernic, especially Asia (19,20) Vaccination programs to prevent perinatal. childhood, and adult I - ISV infections among Alaskan Nativea were begun in late 1982. as a result, the incidence of acute hepatitis B in this population lies declined by over 99% (6) Hepatitis B vaccine was integrated into vaccination schedules for infants in American Samoa beginning in 1986 and by 1990 was incorporated into the schedules of tIre remaining Pacilmc Islands under U S jurisdiction Each year. approximately 150.000 infants are born to women who trove mmmi grated to the United States from areas of the world wheme HBV infection is highly endemic (3) Children born to HBsA 9 positive mothers can be identified through prenatal screening programs However. chitdren horn to HBsA 9 negative immigrant mothers are still at high risk of acquiring HOV infection, usually from other HSV carriers in their families or communities (3. 99.20) Infections among these children can be prevented by making hepatitis B vaccine part of their routine infant vaccine tions (I) Infections among Adolescents and Adults In the United States most persons with hepatitis B acquire the infeclion as adolescents or adults Several specific modes of transmission have been identified Including sexual contact, especially among homosexual men and persons with multiple heterosexual partners. parenteral drug use, occupational exposurE’s. tionise hold contact with a person who has an acute infection or with a chronic carrier, receipt of certain blood products, and hemodialysis However, over one third of patients with acute hepatitis B do not have readily identifiable risk factors (9,2) The rates of NOV infection differ significantly among various racial and ethnic groups (2,21) For example, the prevalence of infection among adolescents and adulte has been shown to be threefold to fourfold greater for blacks then for whites and to be associated with serologic evidence of previous infection with syphilis (21,221 Efforts to vaccinate persons in the major risk groups trove had limited success For example, programs directed at iniecting drug users failed to motivate thorn to receive three doses of vaccine (CDC. unpublished data) Health care providers aie often not aware of groups at high risk of HBV infection and frequently do not uleinlily candidales for vaccination during routine health care visits (COC. unpublished data) In addition, there has been limited vaccination of susceptible household and sexual contacts of HBsA 9 carriers identified in screening progrerlis for blood donors (23) Hepatitis B vaccination of health-care workers appears to have resulted in a substan- tial decrease in tire rate of disease in this group, but lies had little effect on overall rates of hepatitis 0 (2) Moreover, to achieve widespread vaccination of persons at occupational risk, regulations have had to be developed to ensure implementation of vaccination programs (24) Educational programs to reduce parenteret drug use and unprotected sexual activity are important components of the strategy to prevent infection with the truman lmmunode(iciency virus (HIV). which causes acquired immunodeticrency syndrome These programs appear to have reduced the risk of HBV infections among homosex- ual men but have not had err impact on hepatitis B attributeble to parenterai drug use or heterosexual transmission (2) Educational efforts alone are not likely to fully elimninate tire high risk behaviors responsible for IIBV traiisrniissron ------- 4 MMWR Vol 401 No RR 13 November 22. 1991 MMWR 5 EPIDEMIOLOGY AND PREVENTION OF HEPATITIS DELTA VIRUS INFECTION Hepatitis delta virus (HDV) is a defective virus that causes infection only in the presence of active HBV infection (25 HDV infection occurs as either coinfection with HBV or superinfection of an HBV carrier Coirifectron usually resolves, superinfection, however, frequently causes chronic HDV infectiore and chronic active hepatitis Both types of infection may cause fulminant hepatitis Routes of transmission are similar to those of HBV In the United States, HDV •nf ction most commonly afiects persons at high risk of HBV infection, particularly iniecting drug users and persons receiving clotting (actor concentrates (26) Prevent lug acute and chronic HBV infection of susceptible persons will also prevent HDV Infection STRATEGY TO ELIMINATE HEPATITIS B VIRUS TRANSMISSION A comprehensive strategy to prevent HBV infection, acute hepatitis B, and the sequelae of HBV infection in the United Slates must eliminate transmission that occurs during infancy arid childhood, as well as during adolescence and adulthood In the United States it has become evident that HBV transmission cannot be prevented through vaccinating only the groups at high risk of infection No current medical treatment will reliably eliminate chronic HBV Infection and thus eliminate the source of new infections in susceptible persons (27) Therefore, new infections can be prevented only by immunizing susceptible persons with hepatitis B vaccine Routine visits (or prenatal and well-child care can be used to target hepatitis B prevention A comprehensive prevention strategy includes a) prenatal testing of pregnant women for HBsAg to Identify newborns who require immunoprophytaxis for the prevention of peruiatal infection and to identify household conlact who should be vaccinated, bi routine vaccination of children born to HBsA 0 negative mothers, c) vaccination of certain adolescents and d) vaccination of adults at high risk of infection infants anal children can receive liepatilis B vaccine during routine health care visits, no additional visits would be required Coats Include that of the vaccine and the incremental expense associated with delivering an additional vaccine during a scheduled health care visit implementation of this immunization strategy would be greatly facilitated by the development and use of multiple antigen vaccines (e g. diphtheria-telanus-pertU sslslDTPllhePatitia B, Haemophslus ,nfluenzae type b con- jugale/tiepatitis B) These vaccines would reduce the number of injections received by the infant, reduce the cost of administration, and greatly facilitate widespread vaccine delivery Since most l- (BV infections occur among adults, disease control could be acceler- ated by vaccinating emerging at-risk populations, such as adolescents and suscepti’ ble contacts of chronic HBV carriers The recommendation for universal infant vaccinstion neIther precludes vaccinating adults identified to be at high risk of infection nor altars previous recommendations for postexposure prophytaxis for hepatitis B (I) The reduction in acute hepatitis B and hepatitis B associated chronic liver disease resulting lrom universal infant vaccination may not become apparent for a number of yea’s Ifowever universal HBsA 9 screening of pregnant women to prevent perinatal HBV infection has been shown to be cost saving (28, CDC, unpublished data). and the estimated cost of universal hepatitis B vaccination for Infants is less than the direct medical end work loss costs associated with the estimated 5% lifetime risk of Infection (CDC. unpublished data) Currently, tIne cost of era infant’s dose of hepatitis B vaccine delivered in the public sector is about the same as each of the oilier childhood vaccinations Vaccinating adolescents and adults is substantially more expensive because of the higher vaccine cost and the higher implementation costs of delivering vaccine to target populations In the long term, universal infant vaccination would eliminate the need for vaccinating adolescents and high-risk adults PROPHYLAXIS AGAINST HEPATITIS B VIRUS INFECTION Two types of products are available for prophylaxis against HBV infection Hepatitis B vaccine, which provides long term protection against HBV infection, is recommended for both preexposure and postexposure prophylaxis HBiG provides temporary protection (i a, 3 8 months) and is indicated only in certain postoxposure setting, Hepatitis B Immune Globulin HUIG is prepared from plasma known to contain a high titer of antibody against HBsAg (anti HBs) In the United States, HOIG ties an anti HOs titer of >100.000 by radloimmunoessay The human plasma from which HBIG is prepared is screened for antibodies to HIV, in addition, the process used to prepare IIBIG inactivates and eliminates HIV from the final product There is no evidence thai HIV can be transmitted by HBIG (29,30) HepatitIs B Vaccine Two types of hepatitis B vaccine have i’eon licensed ira the United States One, which was manufactured (morn the plasnraa of chronically uii(ecio(l persoiis, is rio longer produced in the United States The currently available vaccines are produced by recombinant DNA technology The recombinant vaccines are produced by using HBsAg synthesized by Saccha romyces ce,ev,s,ee (common bakers’ yeast), into which a piasinid containing the gene for HBsA 9 has been inserted Purified HBsA 9 is obtained by lysing the yeast cells and separating HBsAg from the yeast components by biochemical and biophys’ Ical techniques Hepatitis B vaccines are packaged to contain 10 40 pg of HB5Ag protein/mi after adsorption to aluminum hydroxide (05 mg/nil), thirnerosal (1 20,000 concentration) is added as a preservative Routes and sites of administration The recommended series of three intramuscular doses of hepatitis B vaccine induces a protective antibody response (anti HBs 10 math international units (miUll ml) in >90% of healthy adults and in >95% of infants, children arail adolescents (31-33) Hepatitis B vaccine should be administered Only in lIre deltoid niuscie of adults end children or ira the ariterolaterai thigh muscle of neonates and rnfant the irnrnuraogenicity of tIre vaccine for adults is substantially lower when inlectroris are ------- 6 MMWR November 22, 1931 Vol 40 No HR 13 MMWR 7 erlministe,ed in the buttock (34) When hepatitis B vaccine is administered to Infants at the same time as other vaccines, separate sites in the enterolateral thigti may be used for the multiple in ecttons This method is prelerabie to administering vaccine at sites such as the buttock or deltoid Compared with three standard doses admistered intramuscularly, three low doses of plasma derived or recombinant vaccine administered intradermatiy to adults result in lower seroconversion rates (55%-B1%) and lower (mat titers of ant.-HBs 135-38). although four doses of plasma derived vaccine administered intradermally have produced responses comparable with vaccine administered intramuscularly (39) Plasma derived vaccine administered intradermaiiy to infants and children does not induce an adequate antibody response (40) At this time, low dose initadermal vaccination of adults should be performed only under research protocol with written informed consent Parsons who have been vaccinated intredermally should be tested for anti HBs Those with en inadequate response (anti HHs 10 mlU/mL) should be revaccinated with three lull doses of vaccine administered intramuscularly intrader- mel vaccination should not be used for infants or children Vaccination during pregnancy. On the basis of limited experience, there is no apparent risk of adverse effects to developing fetuses when hepatitis B vaccine is administered to pregnant women (CDC. unpublished data) The vaccine conisins noninfectious HBsAg particles and should cause no risk to the fetus HBV infection affecting a pregnant woman may result in severe disease for the mother and chronic infection for the newborn Iherelora. neither pregnancy nor lactation should be considered a contraindication to vaccination of women Vaccine Usage Preexposute prophylaitis Vaccination schedule and dose The vaccination schedule most often used for adults and children has been three intramuscuiaf iniections. the second and third administered 1 and 6 months. respecliveiy, after the first An alternate schedule of four doses has been approved for one vaccine that would allow more rapid induction of immunity However, for preexposure prophylaxia. there is no clear evidence that this regimen provides greater protection than that obtained with the standard three dose schedule Eecli vaccine has beet, evaluated to determine (he age specific dose at which an optimum antibody response Is achieved The recommended dose varies by product and the recipient’s age and, for infants, by the mother’s HBsAg serologic status (Table 1) In general, the vaccine dose for children and adolescents Is 60%-75% lower than that required for adults (Table 1) Incorporating hepatitis B vaccine into childhoOd vaccination schedules may require modifications of previously recommended schedules However, a protective level of anti-liBs (“10 mlU/mt-) was achieved when hepatitis B vaccine was adinim ,istered in a variety of schedules. including tttose in which vaccination was begin’ soon after birth (5.8.41) In a three dose schedule, increasing the interval between the first and second doses of hepatitis B vaccine has little of fact on immnunOgeniCitY or I i, ,al antibody tiler The third dose confers optimal protection, acting as a booster dose Longer intervals between the last two doses (4 12 niontlis) result in higher final liters of aiiii ItOs (42.43) Sevemal studies have shown that the currently licerisoil vaccines produce high rates of seroconversion (>95%) and induce adequate levels of anti I- lBs when administered to infants at bIrth. 2 months. and 6 months of age or at 2 months. 4 months, and 6 months of age (COC, Merck Sharpe & Oohme. Smmthkline Beecham. unpublished dale) When the vaccine is administered in four doses at 0. 1, 2. and 12 months, the last dose is necessary to ensure the highest fimial antibody titer When hepatitis B vaccine has been administered at the some time as other vaccines, no interference with the antibody response of the other vaccines has been demonstrated (44) If the vaccination series is interrupted after the first dose, the second dose should be administered as soon as possible The second and third doses should be separated by an Interval of at least 2 months If only the third dose ma delayed, it should be administered when convenient The immune response when one or two doses of a vaccine produced by one manufacturer are followed by subsequent doses from a different manufacturer has been shown to be comparable with that resulting from a full course of vaccination with a single vaccine Larger vaccine doses or an increased number of doses are required to induce protective antibody in a high proportion of hemodmalysis patients 145.46) and may also he necessary for other immunocompromised persons te g, those who take immunosuppressive drugs or who are HIV positive), although few data are available concerning response to higher doses of vaccine by these patients (47) Prevaccination testing for susceptibility Susceptibility testing is not indicated (or immunization programs for children or for most adolescents because of the low rate of HBV infection and the relatively low cost of vaccine For adults, the decision to do Recomblv.s H8 Enge rio B Group Dose lug) (m l) Dose li ’g) of HOsAg’ (niL) mothers end children < Ii years 25 1025) 10 Intents of positive (05) mothers, prevention of 5 (051 tO peri,ioiel niection and adolescents (05) 1119 years 5 (05) 20 20 10 (1 0) 20 ii 0) ii 0) years and Dialysis patients other immunocompiomised persons 40 (1 0)’ 40 floth vaccines are routinely administered in a three dose series [ migerma B lie, also 120)’ been licensed for a four dose series administered at 0, I. 2. ond 12 months ‘HUsAg — llepaiiiis B aur(ace antigen ‘Special formulation ‘Iwo 1 0 ml doses ad,nmniste,ed at one sHe. do a four dose schedule or 0 1 2 and mo ,ili ,s ------- S MMWR Novsmbsr 22, 1991 Vol 4OlNo RR-13 MMWR 9 nevaccination testing sliotilil include an eui8tysis of cost effectiveness because of the higher cost of the vaccine Testing for prior infection should be considered for adulle In risk groups with high rates of HBV infection (e g . infecting drug users. homosexual men, and household contacts of HBV carriers) The decision for testing should be based on whether the costs of testing balance the costs of vaccine saved by not vaccinating already-infected persons Estimates of the cost effectiveness of testing depend on three variables the cost of vaccination. the cost of testing for suscapti. bilily. and the expected prevalence of immune persons II susceplibility testing is being considered, careful attention should also be givqn to the likelihood of patient follow up and vaccine delivery ror routine testing, only one antibody test is necessary antibody either to the core antigen lariti HBcl or anti-HBsI Aiiti HOc testing identifies all previously infected persons. including HBV centers, but does not differentiate carriers end non-carriers The presence of anti HBs Identifies previously Infecled persons, except for HRV carriers Neither test has a particular advantage for groups expected to have HBV carrier rates <2%, such as health care workers Anti-HBc may be preferable so that unnecessary vaccination of HBV carriers can be avoided In groups with high carrier rates Postvacclnstlon t..tlng for s.rotoglc r.spona. Such testing is not necessary alter routine vaccination of infants, children, or adolescents Testing for immunity is advised only for poisons whose subsequent clinical management depends on knowledge of their immune Status (e g, infants born to HBsAg positive mothers, dialysis patients and stall, and persons with H1V Infection) Postvaccinalion testing houtd also be considered for persona at occupational risk who may have exposures from injuries with sharp instruments, because knowledge of their antibody response will aid in determining appropriate postexposure prophytaxis When necessary. postvaccination testing should be performed from 1 to 8 months after completion of the vaccine series Testing after immunoprophytexis of infants born to HBsAg- positive mothers ehould be performed from 3to 9 months after the completion of the vaccination series ( see section on Postexposure prophylaxis) Revaccination of nonr.spondeis When persons who do not respond to the primary vaccine series are rovaccinated. 15% 25% produce an adequate antibody response alter one additional dose and 30%-50% alter three additional doses ( 48) Therefore. revaccinalion with one or more additional doses should be considered for persons who do not respond to vaccination initially Poatexposurl prophylaxls After a person has been exposed to HBV. appropriate immunoprophylectic treatment can effectively prevent infection The mainstay of postexpoaure immurro ’ prophylaxis Is hepatitis B vaccine, but in some settings the addition of HBIG will provide some Increase in protection Table 2 provides a guide to recommended treatment for various HBV exposures Transmission of perinatal HBV infection can be effectively prevented if the HOsAg positive mother is identified and if her infant receives appropriate immuno- prophylaxie Hepatitis B vaccination and one dose of H8IG. administered within 24 hours after birth, are 85% 95% effective in preventing both HBV infection end the chronic carrier state (4,5,8) Hepatitis 8 vaccine administered atone in either a three dose or four-dose schedule (Table 1). beginning within 24 hours after birth, is 70% 95% effective in preventing perinatal HBV infections (841) The infants of women admitted for delivery who have not had prenatal HOsAg testing pose problems in clinical management Initiating hepatitis B vaccination at birth for infants born to these women will provide adequate postexposure prophylaxis if the mothers are indeed HOsAg positive The few infections not prevented by either of these treatment regimens were most likely acquired tn utero or may be due to very high levels of maternal HBV-DNA (49) SerologIc testing of infants who receive lmmunoprophylaxis to prevent perinatat infection should be considered as an aid in the long tern) medical management of the few infants who become HBV carriers Testing for anti HAs and Ht3sAg at 9 15 months of age will determine the success of the therapy and, in the case of failure, will identify HBV carriers or infants who may require revaccination Recommendations for postexposure prophylaxis in circumstances other than the perinatal period (Table 2) have been addressed in a previous statement and are reprinted as Appendix A to this document Vaccine Efficacy and Booster Doses Clinical trials of the hepatitis B vaccines licensed in the United States have shown that they are 80% 95% effective in preventing HOV infection and clinical hepatitis among susceptible children and adults (5,33,4 1,50) If a protective antibody response develops after vaccination, vaccine recipients are virtually 100% protected against clinical illness The duration of vaccine induced Immunity has been evaluated in long term follow up studies of both adults and children (48,51 ) Only the plasma derived hepatitis B vaccine has been evaluated because it has had the longest clinical rise. however, on the basis of comparable immunogenicily and short term efficacy, similar TABLE 2 Guide to postexposure immunoprophylaxis for exposure to hepatitis B virus Type of .xposur. Immunoprophylasts Referenc. Pednatal Vaccination I liBlG’ 11 12 Sexual—acute Infection I I BIG Vaccination Appendix Sexual—chronic carrier Vaccination p 12 15 Household coniact— chronic carrier Vaccination p 12 15 Household contact— acute case None unies known exposure Appendix Houeehoid coniaci-acuie case, known exposure I-WIG ± vaccination Appendix Infant f’ 12 months)— acute case in primary care giver HBIG i vaccination Appendix Inadverlent-perCutafleOUS! permucosal Vaccination ‘ ttRiG Ap ieriiin n ‘HBiG Hepatitis B ininiunre giobuli n ------- 10 MMWR November 22. 1991 Vol 40! No AR 13 MMWR 11 results would be expected with recombinant vaccines The magnitude of the antibody response induced by the primary vaccination series is predictive of antibody persis- tmrro. and a logarithmic decline of antibody levels occurs over time Among young adults homosexual men end Alaskan Eskimos) who initially responded to a three- dose vaccine series, loss of detectable antibody has ranged from 13% to 60% alter 9 years of follow up For children vaccinated alter tire first year of life, tire rate of antibody decline has been lower than for adults (51) The peak antibody titers for infants are lower their those for clrildroir immunized after 12 months of age, but the rate of antibody decline is comparable with that observed for adults in the seine population Long term studies of healthy adults and children Indicate that immunologic memory remains intact (or at least 9 years and confers protection against chronic HDV infection, even though anti-HBs levels may become low or decline below detectable levels (48.51.52) In these studies, the I- WV Infections were detected by the presence of anti HBc. No episodes of clinical hepatitis were reported and HBsA 0 was not detected, although brief episodes of viremia may not have been detected because of infrequent testing The mild, inapparent infections among persons who have been previously vaccinated should not produce the eequelae associated with chronic HBV infection and should provide lasting immunity In general, follow.up studies of children vaccinated at birth to prevent perinatal HBV infection have shown that a continued high level of protection from chronic HBV infections persists at least 5 years (52.53) For children and adults whose immune status is normal, booster doses of v8ccine are not recommended, nor Is serologic tesiing to assess antibody levels necessary Tire possible need for booster doses will be assessed as additional information becomes available For hemodialysis patients, vaccine-induced protection may be less complete and may persist only as long as antibody levels are 10 mlU/nil For these patients, the need for booster doses should be assessed by annual antibody testing, and a booster dose should be administered when antibody levels decline to <10 miUlmi. Vaccine Side Effects and Adverse Reactions Hepatitis B vaccines have been shown to be safe when administered to both adults and children Over 4 million adults have been vaccinated in the United States, and at least that many children have received hepatitis 8 vaccine worldwide V.cclne.ssoci.ted side sffscts Pain at the ln(action site (3%-29%) and a temperature greater than 37 7 C (1%-6%) have been among the most frequently reported side effects among adults and children receiving vaccine (5,31-33,50). in placebo-controlled studies, these side effects were reported no more frequently among vaccinees than among persons receiving a placebo (33.50) Among children receiving both hepatitis B vaccine and DTP vaccine, these mild aide effects have been observed no more frequently than among children receiving DTP vaccine alone. Serious adverse events In the United Slates, surveillance of adverse reactions has shown a possible association between Guillalir-Barré syndrome (GBS) and receipt oh the first dose of plasma derived hepatitis B vaccine (54, CDC unpublished datal GUS was reported at a very low rate (05/100,000 vaccinees), no deaths were reported, and all reported cases were amoirg adults An estimated 2 5 million adults receivr’d omro or more dosrs of recombinant hepatitis B vaccine during the period 1966 1990 Available data from reporting systems for adverse events do not indicate air association between receipt of recombinant vaccino arid GBS (COC, unpublished data) Until recently, large-scale hepatitis B vaccination programs for infants leg. Taiwan. Alaska, and New Zealand) have primarily used plasma-derived hepatitis B vaccine No association has been found between vaccination end tire occurrence of severe adverse events, including seizures and GBS (55. B McMahon and A Milire, unpublished data) However, systematic surveillance for adverse reactions has beau limited in these populations, and only a small number of children have received recombinant vaccine Any presumed risk of adverse events possibly associated with hepatitis B vaccination must he balanced against the expected risk of acute end chronic liver disease associahed with tire current 5% lifetimo risk of IWV infpi-tioii in the United States it is estimated that, for each U S birth cohort, 2000 5,000 persons will die from HBV-reiated liver disease As hepatitis B vaccine is introduced for routine vaccination of infants, surveillance for vaccine-associated adverse events will conlirwe to be en important part of the program in spite of the current record of safety Any adverse event suspected to be associated with hepatilis B vaccination should be reported to lire Vaccine Adverse Event Reporting System (VAERS) VAERS forms can be obtairred by calling 1- 800 822-7967 RECOMMENDATIONS Pzevention of Perinatal Hepatitis B Virus Infection 1 All pregnant women should be routinely tested for HBsA 9 during an early prenatal visit in each pregnancy, preferably at the same time other routine prenatal laboratory testing is done HBsAg testing should be repeated late in tire pregnancy for women who are HBsAg negative but who are at high risk of IIBV infection (a g, injecting drug users, those with intercurrent sexually transmitted diseases) or who have had clinically apparent hepatitis Tests for other HBV markers are not necessary for the purpose of maternal screening However, HBsA 9 positive women identified during screening may have HBV-related liver disease and should be evaluated (56) 2 Infants born to motirers who are 1-IBsAg positive should receive the appropriate doses of hepatitis B vaccine (Table 1) and HUIG (05 ml) within 12 hours of birth Both should be administered by intramuscular injection Hepatitis 8 vaccine should be administered concurrently with FIBIG but at a different site Subsequent doses of vaccine should be administered according to the recommended schedule (Table 3) 3 Women admitted for delivery who have not had prenatal HBsAg testing should have blood drawn for testing Wlrile test results are pending, tire irrfant should receive hepatitis B vaccine within 12 hours of birth, in a dose appropriate for infants born to 1 -IBsAg positive mothers (Table 1) ------- 12 MMWR Novemb., 22. 1991 Vol 401 No RB 13 MMWR 13 • lithe mother is later found to be HBsA 9 positive, her inlant should receive the additional protection of HBIG as soon as possible end within 7 deys of birth. although the efficacy of HBIG administered alter 48 hours of age is not known (57) I I HBIG has not been administered, it is important that the infant receive the second dose of hepatitis B vaccine eli month end not later then 2 months of age because of the high risk of infection The last dose should be adminis’ tered at age 8 months (Table 3) b If the mother is found to be HBsAg negative, her infant should continue to receive hepatitis B vaccine as pall of his or her tbutine vaccinations (Tables 3 end 4), in the dose appropriate for infants born to HBsAg-negatsve mothers (Table I) 4 In populations in which screening pregnant woman for HBsAg is not feasible. all infants should receive their first dose of hepatitis 8 vaccine within 12 hours of birth, their second does at 1 2 months of ego. and their third dose at 8 months of age ap • pelt of their childhood vaccinations end wall-child care (Table 3) 5 Household contaCtS and ses partners of HBsAg positive women identified through prenatal screening should be vaccinated The decision to do prevaccinetion testing of these contacts to determine susceptibility to HBV infection should be made according to the guidelines in the section “Prevaccinetion testing for ‘if . fou, dose ichedute is used ltabtas I and 31. the second and third doses should be .dmanIsieied stl end 2 months of age respectively, end the fourth dose at 12 18 months of age TABLE 3 R.commendud schedul. of hepatitis B Immunoprophylasis to prsvent perinetal transmission of hepatitis B virus infection infant born to mother known to be HBA9 poslttv. V.ccln• do..’ Ag. of 12 hours) First Biith (within 12 hours) HBIG’ Bi,ih (within month Second 1 Third 8 months’ tnfant born to mothsr not .cr.sn .d for HBsAg Vaccln• doa. Ag. of 12 hours) First Birth (within be HBeAg HBtG’ if mother i. positive, sdrninister dose to infant as soon as possible. not 1 week slier bi.ih isier than Second 1 2 months” Third 8 months’ •ltRsA H*pslitis B surface antigen ‘See table I for appropriate vaccine dose 1 Hepstitis B immune globulin tHBtG)—O 5 ml administered iniremuscuterty at a site different from that used for vaccine ‘if four dose schedule (Engerix B) is used, the third dose is administered at 2 months of age and the fourth dose at 12 lB months ‘First dose dose (or infant of HBeAg positive,mother (see Table ii If mother is found to be HBsAg posItive, continue that dose, if mother is found to be HBsAg negative. use approprIate dose from Table I “infants of woman who are HBsAg negative can be vaccinated at 2 months of age susceptibility “ Hepatitis B vaccine should be administered at the age-appropriate dose (Table I) to those determined to be susceptible or ludged likely to be susceptible to infection Universal Vaccination of Infants Born to HBsAg-Negatlve Mothers 1 Hepatitis B vaccination is recommended for all infants, regardless of the HBsA 9 status of the mother Hepatitis B vaccine should be incorporated into vaccination schedules for children The first dose can be administered during the newborn period, preferably before the infant is discharged from the hospital, but no later than when the Infant is 2 months of age (Table 4) Because the highest titers of •nti-HBs are achieved when the last two doses of vaccine are spaced at least 4 months apart, schedules that achieve this spacing may be preferable (Table 4) However, schedules with 2-month intervals between doses, which conform to schedules for other childhood vaccines, have been shown to produce a good antibody response (Table 4) and may be appropriate in populations In which ills difficult to ensure that infants will be brought back for all their vaccinations The development of combination vaccines containing HOsAg may lead to other schedules that will allow optimal use of combined antigens 2 Special efforts should be made to ensure that high levels of hepatitis B vaccination are achieved in populations in which HUV infection occurs at high rates among children (Alaskan Nelives, Pacific Islanders, and infants of immigrants from countries in which HBV is endemic) TABLE 4 Recommended schedules of hepatitis B vaccination for infants born to HBsAg-nsgatlvl mothers H.pstitis OptIon 1 Dose 1 Birth—before hospitat discharge Dose 2 Dose 3 I 2 rno,,ihs’ 6 lB months’ Option Dose 1 Dose 2 1 2 months’ 4 months’ Dose 3 6 18 months’ Hepatitis H surface antigen ‘Hepatitis Uaomophs the same B vaccine can be adn,unistemed Iua lnfluenzee type b confugaia. visit simultaneously with, diphtluenie tetanus pentiussis. meastes mumps rubetia and onat poiio vaccines at Vaccination of Adolescents At) adolescents at high risk of infection because they are in)ecting drug users or have multiple sex partners (more than one partnerl6 months) should receive hepatitis B vaccine Widespread use of hepatitis B vaccine is encouraged Because risk factors are often not identified directly among adolescents. univei sat hepatitis B vaccination of teenagers should be implemented in communities where Injecting drug use. pregnancy among teenegers. and/or sexually transmitted diseases are common ------- 14 MMWR November 22, 1991 Vol 401 No RH 13 MMWR 15 Adolescents can be vaccinated in school based clinics, community health centers. (amity planning clinics, clinics for the treatment of sesuelly transmitted diseases, and special adolescent clinics The 0, 1-, and 6 month schedule is preferred for vaccinating adolescents wilh the age appropriate dose of vaccine (Table 1) However, tIre choice of vaccination schedule should take into account the feasibility of delivering three doses of vaccine over a given period of time The use of alternate schedules (a g, 0, 2. and 4 months) may be advisable to achieve Complete vaccination Vaccination of Selected High-Risk Groups Efforts to vaccinate persons at high risk of HBV infection should follow the vaccine doses shown In Table 1 High risk groups for whom vaccination is recommended include I Persons with occupational risk HBV infection is an occupational hazard for heallh care workers and for public safely workers who have exposure to blood in the workplace (24.58) The risk of acquiring HBV infections from occupa- tional exposures depends on lhe frequency ol percutaneous and permucosel exposwe to blood or blood Contaminated body fluids Any health-care or public Safety worker may be at risk for HBV exposure, depending on the tasks he or she performs Workers who perform tasks involving contact with blood or blood contaminated body fluid should be vaccinated (24.58,59) For public- safety workers whose exposure to blood is infrequent, timely postexposure prophylexig should be considered rather than routine preoxposure vaccina lion For persons in health care fields, vaccination should be completed during training in schools of medicine, dentistry, nursing, laboratory technology, and other allied health professions, before trainees have their first contact with blood 2 Clients and stall of Institutions for the developmentally disabled Susceptible clients in institutions for lhe developmentally disabled, as well as staff who work closely with clients, should be vaccinated Susceptible clients and staff who live or work in smaller residential settings with known HBV carriers should also receive hepatitis B vaccine Clients discharged from residential institutions mb community programs should be screened for HBsAg so that appropriate measures can be taken to prevent HBV transmission Those measures should include both environmental controls and appropriate use of vaccine Staff of nonresidential day-care programs for the developmentally disabled (e g. schools. sheltered workshopsl attended by known HBV carriers have a risk of infection comparable Will) Ihat of health care workers and therefore should be vaccinated (60) The risk of infection for other clients appears to be lower than the risk for staff Vaccination of clients in day care programs may be considered Vaccination of classroom contacts is strongly encouraged if a classmate who is an HBV carrier behaves aggressively or has special medical problems le g , exudative dermatitis, open skin iesions) that increase the risk of exposure to his or tier blood or serous secretions 3 Hemodialysls patients Hepatitis B vaccination is recommended for suscepti- ble hemodialysis patients Vaccinating palienis early in the course of their renal disease is encouraged because patients with uremia who are vaccinated before they require dialysis are more likely to respond to the vaccine (61 Although their seroconversion rates and enti HBs titers are lower than those of healthy persons, patients who respond to vaccination will be protected from infection, and the need for frequent serologic testing will be reduced (62) 4 Reclpi.nts of certain blood products Patients who receive clotting factor concentrates have en increased risk of HBV infection and should be vaccinaied as soon as their specilic clotting disorder is identified Prevaccination testing is recommended for patients who have already received multiple infusions of these products 5 Household contacts end sex partners of HBV carrIa s All household and sexual contacts of persons identified as HBaAg positive should be vaccinated The decision to do prevaccination testing to deternuiie susceptibility to IIBV infection should be made according to the guidelines described earlier in the section “Prevaccinetion testing for susceptibility” Hepatitis B vaccine should be administered at the age appropriate dose flable 1)10 those determined to be susceptible or judged likely to be susceptible to infection 6 Adoptees from countries where HBV Infection is endemic Adopted or fostered orphans or unaccompanied minors from countries where I -ISV inlec hon is endemic should be screened for HH5A 9 (3) If the children are 1 -IBsAg positive, oIlier family members should be vac inaied (63) 7 International travelers Vaccination should be considered br persons who plan to spend more than 6 months in areas wilh high rates of HBV infection and who will have close contact with the local population Short term travelers who are likely to have contact with blood (e g, in a medical setting) or sexual contact with residents of areas with high or intermediate levels of endemic disease should be vaccinated Vaccination should begin at least 6 months before travel to allow for completion of the full vaccine series, aluliough a partial series will offer some protection The alternate four dose schedule Isee Table 1) should provide protection ii the first three doses can be delivered beloie departure a ln ecting d,ug users All injecting drug users who are susceptible to HBV should be vaccinated as soon as their drug use begins Because of the high rate of HBV infection in this population. pievaccination screening should be considered as outlined in the section “Prevaccination tesliiig (or susceptitnl- ity” Injecting drug users known to have I-IIV infection should be tested br anti HBs response after compietion of the vaccine series Those who do riot respond to vaccination should be counseled accordingly 9 Sexually active homosexual and bisexual men Susceptilile sexually active homosexual and bisexual men should be vaccinated Because of the high rate ol HBV infection in this population. prevaccination screening should be considered as described in the section “Prevaccinration testing for susceptrbil ity” Men known to have HIV infection should be tesled for anti i-1 s response after completion of tire vaccine series Those who do not respond io vaccine lion should he counseled accordingly 10 Sexuallyactive heterosexual men and women Vaccination is recornrinenidrid for men and women who are diagnosed 8s havir recoiiiiy acquired oilier sexually treneriritted diseases for prostituies and for persons who have a ------- 16 MMWR Nov.mbsr 22. 1991 Vol 401 No RH 13 MMWR I? hisloly of sexual activity with more than one partner in the previous 6 months 12) Most patients seeis in clinics for sexually iiansn itled diseases should be considered candidates for vaccination 11 Inmates a! Iong-t.,m co ectIonaI !acIIW.s Prison officials should consider undertaking screening and vaccination programs directed at inmates with histories of hIgh risk behavIors EVOLVING ISSUES IN HEPATITIS B IMMUNIZATION PROGRAMS Hepatitis B vaccine has now been used extensively throughout the world and is currently being incorporated into the Expanded Programme on Immunization of the Wotid Heallh Organization ( 16) New information, vaccines, and technology will have implications for this effort, end adjustments and changes eve expected to occur over the years Some of the issues that can be expected to be addressed in clinical and operational studies include the following’ I In most dřveloplng countries with hřpatiti B irnmtiniration programs, the first dose of vaccine is adtniiiistered to all itifaitta soon after birth to prevent perinatel infections, pregnant women are not screened for HBsAg. and HBIG is not used (8,16.45) The feasibility and effectiveness of Incorporating thIs approach into the hepatitis B prevention strategy for the United Stales must be evaluated 2 Booster doses of hepatitis B vaccine have not been recommended because of the persistence of protective efficacy 9 years alter vaccination (48,5 11 The duration of protective efficacy for adolescents who were vaccinated during infancy or childhood must be evaluated, Ihe results will determine future recommendations concerning booster doses 3 FlexIble dosage schedules are required to effectively integrate hepatitis B vaccine into current and future immunization programs for infants Schedules may change as optImum dosage and timing are studied and new information becomes available 4 Multiple-antigen vaccines that incorporate HB5Ag as one component are currently being evalualed The routine use of these vaccines may alter child hood vaccination schedules or may result in the administration of additional doses of certain antigens However, these vaccines should greatly facilitate vaccine delivery and minimize the number of injections flele,encei I COC Protection egainst viral hepaiitis recommendations ol the Immunization Practices Advisory Committee IACIPI MMWR 1990,39 5 22 2 Alter Mi, Hadlor SC Margohs HS, at at The changing epidemiology of hopatilis B in the United States need (Or alternative vaccination strategies JAMA 1990,263 1218 22 3 Margohs HS. Alto, Mi, Hadler SC Hepatitis B evolving epidemiology end implications for control Semin Liver Di, 1991,11 8492 4 Siovens CE Toy PT. Tong Mi. et a) Perinatal hepatiiis B virus transmission in the United Sisie. prevention by passive active immunization JAMA 1985,253 1740 S S Stevens CE Taylor PE. Tong MJ. et al Yeast recombinant hepatitis B vaccine efficacy with hepatiiis B immune giobulin in preveniion oi perinaisi hepatiiis B virus transmissIOn JAMA 1907 251 26126 6 McMahon BJ. Rhoades ER Heyward WL 01 at A comprehensive prograririne to reduce tire incidence of hepaiiiis B virus intection and its sequeiae in Alaskan Natives tancet 1987.2 11346 7 Stevens CE. Neurath HA. Beasiey HP Szmunesg W HBeA 9 and anti HOe deiection by radioimmunoaasay correlation with vertical transmission of hepaiiiis B virus in Taiwan J Med Virol 1919,3 237 41 8 Xu 1 V. Liu C B. Francis OP. oi al Prevention of perin tbi acquisition of hepaiili B virus carriage using vaccine preliminary report of a randomized double blind placebo controlled snd comparative trial Pediatrics 1985.76 7138 9 Be.sley HP Hwang I. V Epidemiology of hepatoceiiular carcinoma in Vyas ON. Dienstag JL. l loolnaçile itt. ads Viral hepaiitis •nd liver disease New York Grime & Straiton 1984 209 24 10 Beasley HP. Hwang I. V Postnatal infectivity of hepatitis B surface antigen carrier mothers J infeci Dis 1983.147 185 90 II Jonas MM, Schif I ER. O’Sullivan Mi. etal Failure of itie Centers for Disease Controi c,iteria to identify hepatitis B infeclion in a large municipal obsietrical population Ann Intern Med 1987.107 335 7 12 Kumar ML. Dawson NV McCuiiough AJ. at al Should oil pregneni women be screened for hepatitis 81 Ann Intern Med 1987. 107 273 7 13 American Academy of Pediairics Hepatilis B in Peter 0. Lepow ML McCracken OH. Phiitips CF. ads Report of the Commiltee on Infectious Diseases 22nd ed Elk Grove Village. IL American Academy of Pediatrics. 1991 238 55 14 Aiurericari Acamioiiiy oi roilinirics nimul Aiiinrirrir, CiiilntiR nI Oiisir’nir nnrt (lyricroloqy Guidelines for preinaiai care 3rd ed Eik Grove Viilage IL Aineurcan Acautonny of Pedmaiiics. 1991 tin pressi 15 McMahon BJ, Alwerd WIM Hali OH. at al Acute hepatitis B virus infection reiation of age to the clinicai expression of disease and subsequent development of the carrier stale J infect Dis 1985.151 599 603 16 World Heaith Organization Progress in tIme control of viral hepatitis inenrioranduni Ironi a WHO meeting Bull WItO 1988.66 443 55 17 Schroeder MT. Bender IR, McMahon Hi. olaf Prevalence of hepatitis B in seiected Alaskan Eskimo villages Am J Ipidemiol 1983 1185439 18 Wong DC. Purceil flIt. Rosen I. Prevalence of enlihody to hepatitis A and hepatitis H viruses in selected popuiaiions of the South Pacific Aini J Etiidemrol 1919 110 221 36 19 Franks AL, Berg Ci. Kane MA. et al Hepatitis B virus infection arnourg children born iii the United Slates to Southeasi Asian refugees N EngI i Med 1989 321 1301 5 20 Hurl. MB Mast EE. Davis JP Horizonial transmission of hepatitis B virus infection 10 United States born children of Hmong refugees Pediatrics 1992 tin press) 21 McOuilten GM. Townsend TR. Fieids HA et al The seroepidenriotogy ol hepatitis B virus in the United States. 1976 io 1980 Am J Med 1989 BllSuppl 3A) 5 10 22 COC Raciai differences in rates of hepatitis B virus infection-United States 1976 1900 MMWR 1989,38 81821 23 Moyer LA Shapiro CN. Shulman G. Orugliera P A survey of hepatitis B surface antigen positive blood donors degree of understanding and action taken alter notification In Hollinger FO. Lemon SM. Margolis HS. eds Viral hepatitis and iiver disease Batlimore WillIams & Wilkins. 1991 728 9 24 US Department of Labor. US Deparirneni of Heatih and Human Services Joint Advisory Notice Protection aqainsi exposure to hepatitis B virus ( ( ISV) arid hunian irninunodaficienicy virus iHiV) Federal Register 1987.52 41818 24 25 Ruzzetto M The delta agent Hepatology 1983.3 729 37 28 Hadler SC Fields HA Hepelitis delia virus In Belslie RB. ad Textbook of human virology SI Louis Mosby Year Book, 1991 749 66 27 Perriiio HP. Schilf ER. Davis FL. et ai A randomized. controlled trial of interferon aifa 2h alone and after predrsisone withdrawal for the treatment of chronic hepatitis B N Engi J Med 1990.323 295 301 29 Arevalo JA. Washington E Cost effectiveness of prenatal screening and immunization for hepatitis B virus JAMA 1988 259 365 9 29 COC Safety of itienapeuric immune globulin preparaiions with raspeci in iransirrislinir for human I tyniphotroirhic virus type iitiiyirptiadniniopaitry a ociarerl virus iirtet,iiriii MMWII 1986,35 231 ‘I ------- I. MMWR November 22, 1991 Vol 401 No R B - f l MMWH 19 30 Walls MA Writek AL (J iStein iS at al Iriactivaliriri end perluliori of human I cell lym ptiolrophic virus, type tIl, during ethanol fractionation of plasma Transfusion 1988, 26 210 3 31 Zaiac BA West Di. McAleer Wi, Srolnlck EM Overview of clinical Studies with hepalitis 8 vaccine made by recombinant DNA J InlecI 1986.i3lSuppl Al 3945 ‘I? ftrurlro E Siunuiuuy ul afoly attn efllu.aty dale on a yeast derived hepatitis B vaccine Am i Med I 989 .OlfSuuppl 3A) 14, 70, 33 S:muness W. Slevena CE. Harley Li, at at Hepalitis B vaccine demonstration of efficacy in • couulrolled clinical trial in a high risk population in the United Stales N Engi J Med 1980. 303 833 41 34 Shaw FE Jr. Guess HA. Boats JM at .1 FIfed of anatomic inlectuon site age, and smoking on the immune response to hepatitis B vaccination Vaccine 1989.7 425 30 35 edlietd RH, Innis 81. Scott AM, Cannon HG. Bancroft WH Clinical evaluatIon bf low dose lnlradermaliy administered hepalilis B vaccine, a cosl reduction strategy JAMA 1985. 254 3203 6 36 Coleman Pi. Shaw FE J,. Serovich J. Hadier SC. Maigolls KS Intradermal Piepatllis B vaccination in a large hospital employee population Vaccine 1991.9 7237 31 Gonzalez ML. Usandliaga M. Alomar P. at .1 Intradermal and Intramuscular roule for vaccination against hepatitis 0 Vaccine 1990,0 402 5 30 Lancaster 0, 11am S. Kaiser AB Immunogenicily of the Intradermal route of hepati Ii. 8 vaccination with use of recombinant hepatitis B veccihe Am J Infect Control 1989,11 126 9 39 King JW, Taylor EM, Crow SD. et .1 Comparison of the immunogenicity of hepatitis 0 vaccine administered intradarmsliy and intramuscularly Rev Infacl Ols 1990,12 1035 43 40 Ku 2 V. Margotis ItS Determinant, at hepatitis B vaccIne elficacy and ImplIcations for vaccination slrategles Monogr Vlrol 1991 Ito press) 41 Poovorawan V. Sanpavat S. Pongpuniert W, Chumdarmpsdetauk S. Sentrakul P. Safary A Protective efficacy of a recombinant DNA hepalllls 0 vaccIne In neonate, of ItO. antigen positive mothers JAMA 1989.261 3278 81 42 Jug W SchmIdt M, Dienhardt F Vaccination against hepatitis B comparison of three diflerent vaccination schedules J Intact Dna 1989 160 786 9 43 Hadler SC, Monion MA. Lugo DR Parer M Effect of timing of hepalttis B vaccine dose on rrsluiunso In vaccuisri in Viuclia iriuiinrui Vaccine 1989,1 106 tO 44 Cnuraaget P. Yvontiet B, Rolyvefrl (H. Barnes .11. Duop Mar I, Chiron .JP SImultaneous administration of diphtheria tetanus pertuasis polio arid hepalilis B vaccines in a simplified immunization program Immune response to diphtheria toxoId, tetanus toxoid. perlussis and hepatitis B surface antigen Infect Immun 1986.151 784 7 45 Stevens CE. After Hi. Taylor PE. 01 at Hepatitis B vaccine In patients receiving hemodialysls Immunogenlctty and efficacy N Engl J Med 1984.311 498 601 48 Jilg W. Schmidt M, Welnel B. et at Immunogenlcity of recombinant hepatitis B vaccine in dialysis patients J Hapatol 1988. 3 190 5 4? LiiIlror AC, Corey 1, Murphy VI, Hau,dsfuold HI-I Antibody to human irnmunodoluciency virus IltiVi and subopttmal response to hepatitis B vaccination Ann Inlern Med 1998. 109 lOt S 48 Hadler SC, Francis OP. Maynard iF. at al Long term Immunogenicity and efficacy of hepatitis B vaccine In homosexual men N EngI J Med 1986,315 209 14 49 Lee S 0, Lo K J, Wu J C. at al Prevention of maternal infant hepatitis B virus transmission by urnmunuaiinn role of serum hepatitis B virus DNA Ifepatology 1986,8 369 73 50 Francic or. Hauler SC. Thompson SE. el at Prevention of hepalitis B with vaccine report from the Coolers for Disease Control multi center efficacy trial among homosexual men Ann Intern Med 1982,97 382 6 51 Wainwright RB. McMahon Bi. Bulkow LA. et al Duration of irnmunogenicity and efficacy of hepatitis B vaccine in a Vupik Eskimo population JAMA 1989:261 2362 6 52 Lo K J. Lee S 0. Isal V T. et al Long lerrn Immunogenicity and efficacy of hepatitis B vaccine In Iniants born to HBeAg positive HOsA 9 carrier mothers Hepatology 1988.8 1647 50 53 Hwang L V, Lee C V. Beesley HP Five year follow up of HBV vaccination with plasma derived vaccine in neonates Evaluation of immunogenicily and efficacy against perinatal transmission in Hollinger FR. Lemon SM Margolis HS. ada Viral hepatitis and liver disease Baltimore Williams Si Wilkins. 1991 75961 54 Shaw FE Jr. Graham Di Guess HA at al Postinarkeling surveillance br neurologic adverse events reported after hepatitis B vaccination experience of the first three years Am J Epidenuiol 1988 121 331 52 55 Chen 0 S Control of hepatitis B in Asia mass immunization program iii Taiwan In Hollinger FB. Lemon SM Margolis I I S. ads Viral hepatitis amid liver disease Baltimore William, & Wilkins. 1991 1)69 66 COC Public Health Service Inte, agency guidelines for screening donors ol blood, plasma. organs. tIc ues miil srrmwmu for evirtriwe of liei)atttts B and liepatitic C MMWR 1991,40 56 5? Beesley ftP, ltweurg I V. Stevens CE, et al Eflucecy of hepatitis B immune globulin for prevention of perimialal transmissIon of the hepatitis B vi,us Carrier stale final report of a randomized double blind, placebo controlled trial Hepatology 1903.3 135 41 58 CLIC Guidelines for prevention of transmission of human ininrurnodeticrerucy vinus and hepatitis B virus to health care end public safety worker, MMWR 1989.3BISuppl 6) 5 IS 59 Department of Labor Occupational exposure to bioodbonne pathogens proposed rule and notice of hearing Federal Register 1989.54 23042 139 60 O,euer B. Friedman SM. Muilner ES. Kane MA, Snyder RH. Maynard iF Transmission of hepatitis B virus In classroom contacts of mentally retarded carriers JAMA 1985,254 3190 5 61 Seaworlh 0. Drucker J, Starling J. Drucker H, Stevens C. Hamilton J Hepatitis 8 vaccines in patients with chronic renal failure before dialysis J Infect Dus 1988.167 332-7 62 Moyer LA, Alter Mi. Favero MS Hemodiatysls.associated hepaliti, B revised reconumen dalions ho, serologic screening Semin Dialysis 1990,3 201 4 63 Hershow BC. Hadter SC. Kane MA Adoption of children from Countries with endemic hepatitis B transmission risks end medical issues Pediatr Infect Dis J 1987,6 43) 7 ------- Vol 4OINo RR13 MMWR APPENDIX A Postexposure Prophylaxis for Hepatitis B Adapted horn COC Protecuron agauiisl viral hepatitis reco,,,mendalio,is of the lnimu,iizatioii Practices Advisory Coin,inttee (ACIP ) MMWH 1990,39(No HR 2) 17 22 INTRODUCTION Prophylactic treatment to prevent infection after exposure to HBV should be considered in the following situations perinaial exposure of an ln(a,il born to an HBsA 9 positive mother, inadvertent percutaneous or permucosat exposure to HBsAg positive blood, sexual exposure to an HBsAg positive parson, and household exposure of an infant 12 months of age to a primary ca,e giver who has acute hepatitis B Various studies huve established the relative efficacies of HBIG and/or hepatitis 8 vaccine in different exposure situations For an infant with perinatal exposure to an H8sA 9 positive and 1 -IBeAg positive mother, a regimen conibmning one dose of FIBIG at birth with the hepatitis B vaccine series started soon after birth is 85% 95% effective in preventtng development of the H BV carrier state IA ? A3) Regimens involving either multiple doses of HBIG alone or the vaccine series alone have 70% 90% efficacy (A4,A5 I For inadvertent perrcutaneous exposure, only regimens including HOIG arid/or Immune globulin (IGI have bean studied A regime,i of two doses of 116 1G. one given after exposure and one a month later, is about 75% effective in preventing hepatitis B in this Betting 1A6.A7) For sexual exposure to a person with acute hepatitis B, a single dose of HOIG is 75% effective if administered within 2 weeks of last sexual exposure 1A8) The efficacy of IG for postexposure prophytaxis is uncertain, IG no longer has a role in postexposure prophylaxis of hepatitis B because of the availability of HBIG and the wider use of hepatitis B vaccine Recommendations on postexposure prophylaxis are based on available efficacy data and on the likelihood of future HHV exposure for the person requiring treatment In all exposures, a regimen combining H8I(. with hepatitis B vaccine will provide both short- and long term protection, will be less costly than the two (lose HOIG treatineiit alone, end Is the treatment of choice Acute Exposure to Blood that Contains (or Might Contain) HBsA 9 For Inadvertent percutaneous Ineedlestick. laceration, or bite) or permucosal (ocular or mucous membrane) exposure to blood, the deciston to provide prophylaxis must include consideration of several factors a) whether the source of the blood is available. b) the HBsAg Status of the source, and cI the hepatitis B vaccination and vaccine response status of the exposed person Such exposures usually affect persons for whom hepatitis H vaccine is recommended For any exposure of a person not previously vaccinated, hepatitis H vaccination is recoflimeiinfed After army such exposure a 1)100(1 sample should be obtai,ied lronm tho person who was the source of the exposure and should be tested Ion URsAg lime hepatitis H ------- MMWR Novsmb.r 22. 1991 Vol 40! No BR 13 MMWR 23 vaccination status and anti HBs response status (if known) of the exposed person should he reviewed The outline 1)010w and Table Al summarize prophylexis for percutaneous or peimucosal exposure to blood according to the HBsA 9 status of the source of exposure and the vaccination Status and vaccine response of lhe exposed person For greatest effectiveness, passive prophylexis with HOIG, when indicated, should be administered as soon as possible slier exposure since its value beyond 7 days alter exposure is unclear 1 Source of exposure known and H8sAg positive a Exposed person has not been vaccinated or has not completed vaccination Hepatitis B vaccination ahould be initiated A single dose of HBIG (006 mlikg) should be adrnirusteied as soon as possible after exposure end withrn 24 hours, if possible Tb. first dose of hepatilie B vaccine should be administered intramuscularly at a separate silO (deltoid for sdulle) and can be administered simultaneously with HBIG or within 7 days of exposure, subsequent doses should be adrninistered as recommended for the specific vaccine lithe exposed person has begusi but has not completed vaccination, one dose ol HHlG should be administered immediately and vaccination should be completed as schecl iiled b Exposed person lieS already been vaccinated against hepatitis B. and anti HBs response status is known TABLE Al exposure for hepatitis B prophylexi. following percutaneous Ti..tm.nt when source is found to b. Unknown or Eaposed p.rson HB.Ag po.Itiv. HHsA 9 nsg.tiv. not t.st.d Unvscctr taisd Administer ilHiG I • and initiate hepatitis B vaccine’ inii,ai hepatitis B vaccine’ inltiaie hepaiiti , B vaccine’ Pnsvlouil v.ccin t .d Known responder Test exposed person for anti 118, I If adequate. no treatment 2 Il inadequate, hepatitis B vaccine hoosier dose No treai,nerit ‘ No ireat,nent Known non responder 11816 a 7 on HBtG a I, plus 1 dose of hepatitis B vaccine No treatment If known high risk source, may treat a, if source were IIBeAg positive Response unknown Test exposed person for anti HB I II inadequate 11816 x 1. plus hepatitIs B vaccine booster dose 2 II adequate no treatment No treatment Test exposed parson br anti 118, 1 1 If Inadequate. hepatitis B vaccine hoosier dose 2 ii adequate. no treatment liepei ,Ius B ii,,rirune globulin fitBiOl dose 008 intikg intraitiuscuierly llepetiirs B vaccine dose see labia 1 ‘Adequate anti liRe i , ‘ 10 ri,Iiti litter neiio, ,eI units (1) lithe exposed person is known to have had adequate response in the past. the anti HBs level should he tested unless an adequate level has been demonstrated within the last 24 months Although Current data show that vaccine induced protection does not decrease as anttbody level wanes. most experts consider the following approach to be prudent (a) lithe anti HBs level is adequate, no treatment is necessary (b) lIthe anti HBs level is Inadequate, • a booster dose of hepatitis B vaccine should be administered (2) If the exposed person is known not to have responded to the primary vaccine series, he or she should receive either a single dose of HBIG and a dose of hepatitis B vaccine as soon as possible abler exposure, or two doses of HBIG 1006 mI/kg), o,w as soon as possible after exposure and the second 1 month taler The lalter treatment is preferred for those who have not responded to at leasl four doses of vaccine c Exposed person has already been vaccinated against hepatitis B. attd the anti HBs response is unknown The exposed person should be tested for anti liBs (1) Ii fIts exposed person lies adequate antibody, ito addiiional treatineiit is necessary (2) lithe exposed person has inadequate antibody on testing, one dose of HB1G (0 06 niL/kg) should be administered imniiediatelv arid a standard booster dose of vaccine administered at a different site 2 Source of exposure known and l-fflsAg-negative a Exposed person has not been vaccinated or has riot completed vaccination If unvaccineted, the exposed person should he edrniiiistered the first dose of hepatitis B vaccine within 7 days of exposure, and vaccination should be completed as recommended tithe exposed person lies not completed vacci nation. vaccination series should be completed as sclieriuled b Exposed person has already been vaccinated against hepatitis B No treattisenit is necessary 3 Source of exposure unknowns or not available for testing a Exposed person has riot been vaccinated or lies not conipleted vaccination Ii unvaccirsated. the exposed person should be administered the first dose of hepatitis B vaccine wIthin 7 days of exposure and vaccination should be completed as recommended If the exposed person has not completed vacci nation, vaccination should be completed as scheduled b Exposed person lies already been vaccinated against hepatitis B, and anti HOs response status is known (1) If the exposed person is known to have had adequale response in the past. no treatment is necessary (2) If the exposed person is known not to have responded to the vaccine, prophylaxis as described earlier in seclion 1 b (2) under “Source of expo. sure known and HBsAg .positive” may be considered if the source of the exposure is known to be at high risk of HBV infection c Exposed person lies already been vaccinated against hepatitis B, arid the anti HHs response is unknown The exposed person should be tested for anti HUs A a e juai enitrbody level us 10 mlIJ/nnl ------- 24 MMWR November 22. 1991 Vol 401 No RH 13 MMWR 25 (1) II the exposed 1)015011 has a(le(lriale anti fiRs. 110 lreatiiieril Is necessary 121 If the exposed person has inadequate 8011 HOs. a standard booster dose of vaccine should be administered Sex Partners ol Persons with Acute Hepatitis B Virus Infection Sex partners of HBsA 9 positive persons are at increased risk of acquiring HBV infection, arid HBIG has been shown to be 75% effective in preventing such infections (A8 I Because data are limited, the period after sexual exposure during which HB1G is effective is unknown, but extrapolation from other s ttings makes it unlikely that this period would exceed 14 days Before treatment, testing sex partners (or susceptibility is recommended if it does not delay treatment beyond 14 days after last exposure Testing for antl-HBc is the most efficient prescreening procedure to use in this population All susceptible persona whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (006 niLlkgl and should begin the hepatitis B vaccine series if prophylaxis can be started within 14 days of the last sexual contact or if sexual contact with the infected per son will continue Administering the vaccine with HBIG may improve the efficacy of postexposure treatment The vaccine has the added advantage of conferring long lasting protection An alternate treatment for persons who are not from a high risk group for whom vaccine is routinely recommended and whose regular sex partners have acute HBV infection is to administer one dose of HBIG (without vaccine) and retest the sex partner for HB5Ag 3 months later No further treatment is necessary if the sex pariner becomes HBsAg negative If the sex partner remains HBsAg positive, a second dose of HBIG should be given end the hepatitis B vaccine series starled Household Contacts of Persons with Acute Hepatitis B Virus Infection Since infants have close contact with primary care givers and they have a higher risk of becoming HBV carriers after acute I-IBV infection, prophylaxis of an infant less than 12 rnoiithie of age with HBIG (05 nil) end hepatitis B vaccine is indicated if the mother or primary care giver has acute IWV infection Prophylaxis for other house- hold contacts of persons with acute HBV infection is not Indicated unless they have had identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors Such exposures should be treated like sexual exposures If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine References Al Stevens CE, Taylor PE. Tong Mi, or al Yeast recombinant hepatitis B vaccine efficacy with hepalilis B immune globulin in prevention of perinatal hepatitis B virue transmission JAMA *997,257 2612 6 A? Besstey RP, Hwang I. V. lee 6 C. or at Prevention oh perinatalty transmitied hepatitis B virus Infections with hepatitis B immune globulin arid hepatitis B vaccine Lancel 1983 2 1099 102 A3 Stevens CE. Toy P. Tong Mi. et at Perinatat hepatitis B virus *ransmi,sion in the United States prevention by passive active immunization JAMA 1985,253 1740 5 A4 Beastey HP. Hwang L-V. Stev8ns CE. 01 at Efficacy of hepatitis B immune globulin (or prevention of periiiaixl transmission of the hepatitis B virus carrier siate boat reponi of a randomized double blind pt8Cat)0 controlled filet Hepatotogy 1983 3 135 41 AS Xu Z Y tiu C B Francis oP. et el P,eveniioin of peririetal ecqulalilon of hapailile 0 virus car i isqi. Iis linq varc,irn’ ti. rliriiinar y r i. ini I of n i a.uitoniii,ed dot ,I,fe lili,id 1 it aceimo coniiroilcil and comparelive Irial Pediairics 1985 76 7138 A6 Seeff LB Wright (C Zimmerman Hi at at Type B hepeillis alter rieedlestick exposure Prevention with hepatitis B iniinuiie globulin hinal report ol itia Veterans Administration Cooperative Study Ann triter,, Med 1970.89 205 93 Al Grady GF. Lee VA. Prince AM et at Hepatitis B immune globulin for accidental exposures among medical personnel final report of a mulliceriter conirotted Iruel J Infect Die 1978,13862530 A9 Redekes AG. Mosley JW Gocke DJ McKee AP Pollack W llepaiiiis I I immune globulin as a prophylactic n ,easiire for spouses exposed to acure iype 8 lier)aiiIiS N Enigl J Med 1975 293 lOSS 9 ------- APPENDIX E ------- APPENDIX E OPTIONAL POST-EXPOSURE TESTING FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV): INFORMATION AND CONSENT/DECLINATION FORMS ------- NEIC Exposure Control Plan: Eloodborne Pathogen Exposures Page 1 Appendix E: Optional Post—Exposure Testing for Human Inmiunodeficiency Virus (HIV): Information and Consent Declination Forms APPENDIX E OPTIONAL POST-EXPOSURE TESTING FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV): INFORMATION AND CONSENT/DECLINATION FORMS A. BACKGROUND INFORMATION ON HIV (AIDS) INFECTIONS Following job related exposure, the NEIC may be required to offer HIV antibody testing without cost to a federal employee. The blood test for antibodies against the HIV determines if someone has had exposure to this virus. A positive test (one that shows the presence of antibodies) does not necessarily mean that you now have or will develop Acquired linmunodeficiency Syndrome (AIDS). A positive test does mean that you should have further medical evaluation by your physician or usual source of medical care. A positive test also means that you may spread the virus by intimate sexual contact or by exposure to infected blood or other body fluids. Individuals who have a positive test must never be blood donors and should seek information from their usual source of medical care on ways to avoid spreading the virus. The virus can also be spread by an infected mother to her developing child. There is presently no permanently effective treatment for AIDS and the disease has thus far been uniformly fatal. The populations which have experienced the highest prevalence of AIDS in the United States include homosexual and bisexual men, people who use intravenous drugs, hemophiliacs, and people who received blood transfusions subsequent to 1977 and prior to the adoption of proper HIV antibody testing of donor blood in 1985. It is unsafe sex and abuse of illegal drugs which have been identified as the major risk factors which place individuals at greatest risk to AIDS through exposure to infected blood and/or other body fluids. ------- NEIC Exposure Control Plan: Bloodborne Pathogen Exposures Page 2 Appendix E: Optional Post—Exposure Testing for Human Immunodeficiency Virus (HIV): Information and Consent Declination Forms B. PROCEDURES FOR VOLUNTARY HIV ANTIBODY SCREENING If the source patient has AIDS, is positive for HIV antibody, or refuses the test, an employee or contractor will be counseled regarding the risk of infection and evaluated clinically and serologically for evidence of HIV infection as soon as possible after the exposure. Testing will be done: immediately after exposure, _______ 6 weeks after exposure, _______ 12 weeks after exposure, and _______ 6 months after exposure. Counselling must be done both before and after HIV testing. All testing for HIV following blood exposure is strictly voluntary. Results will be confidential and will be given only to the employee, in person. Due to the extremely sensitive nature of these test results, and to insure absolute confidentiality,these results will only be presented in person and will not be provided over the phone or by mail. A copy of the results will be stored in a confidential medical file at the clinical facility. It is important for you to be acquainted with the above information before you consider having your blood drawn for this test. ------- NEIC Exposure Control Plan: Bloodborne Pathogen Exposures Page 3 C. STATEMENT OF CONSENT FOR HIV ANTIBODY SCREENING I have read and understand the information on voluntary post-exposure HIV anti-body screening. I have also had an opportunity to ask any questions I may have concerning this screening. I consent to have the blood test for antibodies to the HIV virus, which will be paid for by my employer. I understand that a screening test will be performed first. If this test result is positive, the screening test will be repeated on the same specimen. If the repeat test is positive, a more specific test will be performed on the same specimen. My results will be reported to me in person. Individual test results will be kept confidential in my medical record. Signed Date Social Security Number Witness Date D. DECLINATION OF HIV ANTIBODY SCREENING I have decided not to have the MIV blood screening at this time but understand that my blood will be stored for 90 days in the event that I change my mind and later consent to the test. Signed Date Social Security Number Witness Date ------- APPENDIX F ------- APPENDIX F REFERENCE INFORMATION ON HIV INFECTIONS FROM I4MWR ------- MMWfl CENJIRS EOQ DISEASE CONIROt Jun. 23 $9991 Vol Jo INo S 6 Recommendations and ku Reports MORBIDItY AND MOR AIIIY WUKLY REPORI Guidelines for Prevention of Transmission of Human Immunodeficiency Virus __ and U I Gsi i Pi i 01111. I 9 Oil I IOiSII 11 . 1s. I V Hepatitis B Virus to AtIN & IAIMAN UNV II P M.c 111.1111 S ., . Health —C are and Au. .. GA 333 1111 1 1 Su$ 1.S Public-Safety Workers U S Depadment of Health and Human Services Public Health Seivica Centers for Disease Coi;tioI National Institute for Occupational Safely and health Atlanta Geoigia 30333 II$IS PubIstSIlOfl No (COCI 990012 ------- VoIlISNoI MMWA Serial .uWIc.ikim ki she MMWR are p .Ni Iied by the Epidemininpy P np,an, Duke. ( g l)ke. e Cre,tml PuNk lleabh Sender. U S Ibparnneas ui Nealib NOTICE II.,uiam %uv.cr . Alisnia. tkmp .a m i i i Ibis issue of MMWR Re ommvndagu,n, and Repotis (Vol 38. No S 6) is a repi.uil of an adminisiralive documenl circutaled and reviewed tidier in 1989 I i is being psoviskd SUGGESTED CITATION I fre fo ( T mlss 4 l1 as a. an Issue in she MMWR series as a service so ihe readership I linmuandellckiscy Vim, asid Ikpehk R Vinis io Ikahh Cite aud PuIuiIc.SaIety I Wnuhers MNWR I9* N4no S A) lh’clu 1ve pipe aunthrr , I Cenius for Disease Coimul . WaIst, ft Thi*dk. Pb 0 A thug Di ’etinr This ,rpnn wa. piqwred by Nub..) lnstUvw fat (keupuilonat Safesy and UuIih I Onsiald MIII .,. M 0 Dlre .-s.w Is coiWintuk .. wiih Cen ter ln,In laci lcssD lqasws FtededckA Muqrliy.DVM.PIsD Dl,asuw flu piuducilon .1 thIs sepast was cacidjialed In Ep ldeiabulnpy Prop.... . O(flci Michael (ht,,. N D Acting Dl,aiMr Iki sardA Ooodmin.MD..MPH. Mssat MMWR Sqrfrj EdIbwI.t Services . . .. . . ft FIlkisi Cliv ,chIII. N A CAkJ arid P,ndwsln, FAitiw Revesly Holland Progras Specialist I Copies can hr purchased 1mm Suprilniendini of Document,. U S Oovenimeni I P .bntlrip 0 10cc W.üenplon DC 20402-921S Trkplsnne 120H 1P1 i1I ------- Vo 3S No SS MMW MI Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health-Care and Public-Safety Workers A Rcspoiisc to I’.L. 100-607 The Health Omnibus rrograrns Extension Act of 1988 U.S. Deparlmtnl of Iltaith and liwnan Servke3 Public Health Service Centers for Disease Control Atlanta, Georgia February 1989 ------- V.i3SlNoSS MMWR v TABLE OF CONTENTS Introduction 3 A Background B Purpose and Organiration of Document ... . 3 C Modes and Risk of Virus Traiwnibsion In the Workplace . .. . 4 1). 1 tausmlesion of hepatitis B VIrus to Workers . 3 I health care wuskesi 5 2 Emergency medkal und publlc-salety workers 6 3 VaccinatIon lot hepatitis B virus 6 E Ttammbsk’n of Human Immunodeflciency Virus to Woskeri . . 6 I health case workefl with AIDS 6 2 Human lmmunodefkiency virus t,mambskrn In the workplace ... 7 3 Emergency medical service and pubik-ulety workers 8 Ii. Principle. of Infection Control irid Their Application to Emergency and Publk.Safety Worlera 9 A General Infectio n Control 9 B. Ilniversill Blood and Body Fluid Precautlona to Prevent Occupational lilV and IWV Transmission 9 III. Employer Reaponslbllllim II A General B. Medical 12 I hepatitis B vaccination 12 2. Management of percutaneous esposure to blood and other Infectious body fluk 12 a. Hepatitis B virus po.tespo.ure management 12 b. Human Immunodelklency virus postelposure management.. Ii 3. Management of human bites 14 4 Documentation of espoaure and reporting 14 5. Management of I IBV . or HIV .Inlected workers 15 C. Disinfection. Decontaminalion. and Disposal IS I. Needle and sharp. disposal 16 2 hand washing 16 3 (leanIng. disln lcctlng. and aterilleing 16 4 CleanIng and decontentlnatlng spills of blood 16 5 Laundry 17 6 i)ccontaminatiOn and laundering of protective clothing .. 17 7 InfectIve waste . . . . i7 IV. Fire and Ernulency Medkal Service. . . 19 A Personal Protective Equipment 19 I Glove’ 19 ------- MMW .iu’wu. i.s, Vat MMWR 2 M ks. eye eet, snd owt . . 20 3. Re.uscllalkrn equipment. 20 V. I ..w.!n(ora,menl .nd Cosv,disusSI-Fc0h 17 Oflkm . 22 A. [ aw-EnIo.ctment .,ui Coued nsI Facliliks Co, lderet . 22 I Fights end ,.ulIs • 22 2. cEdk)pulmonsq , adtsIkn 23 Guidelines for Pre’r ntiOfl of a Ls*’ cement Coindde,at 23 Trnnsmj 5 5jofl of I. Sesiches end e4denc hendllii$ 23 2, HandlIng end body t 51OVII Human ImmunodeficiencY Virus 3. Auio ks 25 and 4. Fo.eindc laborstoiks 25 C Couedkmsl FacUlty Cooddersilot. 26 IIcpřIi(is II Virus 2. m :::::::::::::::::::::::::: to IlealthCare and Public-Safety Workers VI. Rd ianc VII. T.bIes The CDC iaIl members lsvted below 5 civcd as .uthms (or ibis publication Robe,’ I Mullan. M I) Edwaid I Bases. M U . M P II James M Hughes M U David M Bell. M I) Ilaiohi W hue. M U Wallel W hood. I, Ma,k A Kane. M I) M r ii M iiy C Clm.ol ilIiiiil M I) . M r I I Ruih.iiine Marcus M r It Maflin S Faveto Pt. I) William i Maitsitic. M U Julia S Gainer. M N Maik I Sc.lly Stephen C tiadler. M I) Phillip W St,.nc ------- V.IISSNoB MMWR I I. lnd A. Background This document is. resporwe to recently enacted legislation. Public Law *00 607. The Health Omnibus Progranw Eztemkm Act of 1988. iltIe II. Programs with Respect to Aequlied Immune Deficiency Syndrome (AIDS Amendments of *988”) SubtItle E, Oeneral p,ovbkjna. Section 253(a)of Title II specliks that “the Secretary of Health .nd Human Services, acting lhwugh the Director of the Centers for Disease Control, shall develop. issue, and disseminate guldeUnes to ill health workers, public a.iety workers tl,iriudlna emer,encv response employees) In the United States concerning — (I) ,,elhodatoredueetherbklnthewO1kplacCOfbCU1fl1IflglnfeCted lts the cilologie agent (or aequired Immune deficiency syndrome; and (2) circumstances under which eaposwe to such ctkkrgk sFnt may occur.— It is further noted that beSectetary lol Health and human Scrvkrsl shalltr.nsmlt the guidelines issued under subsection (a) to the Secretary of Labor br we by the Secretary of Labor InthedeveiopmentObstSfldaUisIObo 1t1edu11&1 theOceupatlonalSafetyand Health Act of *970,” and that “the Secretary, actIng through the DIrector of the Centers with respect to the prevention olexposwe to the etlologic agent for aequl red Immune deficiency syndrome during the proceas of responding to emergencies - Following development of these guidelines and curriculum. “Itihe Secretary shall — (A) transmit toSatepublicheIlthoIf rs00pS01the$U Uu 5rai he niodelcurrkulumdeve l oped under pars gnsph( I )wlth the request that such of (leers disseminate such copies as appropriate throughout the State; and (B) make such copies available to the public.” B. Purpose and Organization of Document The purpose of this document is to provide snoverview of the modes of transmission of human Immunodelkkncy vhw (lflV) in the woriptact. an assessment of the risk of transmission under various assumptions. principles underlying the control of risk, and apedulc risk-control recommendations for employers and workers uris document also Includes lnfornIatlononmedkslmaflagemefltotPe11omwhohave1wtau 51td1Pohhmte at the workplace to these viruses (e g • an emergency medical technicians who Incur a ....Ate itick lnlurvwhile nerformlni professkinaldutks). These guidelines are intended ------- 4 MM No IS MMWH I for tsebyatechnkally Info,medaudlencc. Mnotcdebove.asep.ratemodeieurrkulum b.sed on the principles cm l practices discussed in this document is being developed for use in training workers and wUl contain less Sechnkal wording Inlorinatlon concerning the protection of workei against acquisition of the human Immimodelkiency virus (lIIVj whik pcrformlngjobdutle., the virus that cause. AIDS, is presented here. tnlo,siatkmon hepatitis Betom (lID V I k.bo presented In this docu- meni on the bh of the following mownptlom: • the mode. o( trarwai ksn(oi hepatitis B virus (HDV) are similar to those of IIIV. • the potential (or HDV trsmmisskrn in the oecupslk)hal setting is greater than for “IV. . workplace, and • general practices to present the trsrnm kmof 1IDV will siso minimize the risk of transmission of IIIV Blood borne *rammissk,n of other psthorm not specifically addressed here will be Interrupted by.dherence to the precautions notedbeiow It is Important to nose that the Implementation of control measures for IIIV .nd HBV does nut obviate the need for continued adherence to general infection-control prlndpks and general hygiene mea- sures fe g • hand wsshlng ) for preventing transmission of other infectious disesses to both worker and dient. (leneral guidelines for control of these disemea have been pub. lished (1.2.3). This document wdevelopedpibnltlty to provide guidelines for fire-service personnel. emergency medical technicians. paramedlus (see section IV. page 19). and law enloror- mentandaurecilonhl fadutypenonflel(seeaect lonV.Pal efl) lbroughouttherepotl, pa,.medka and emergency t’ e ’ technicians see called emergency medical wotkers and Ike-service, law enforcement, and correctional facility personneL publk safely worker. - Previously issued guidelines address the necib ol hospital . laboratory • and clinic basedhcatlh-eare w inkers(4.5) Acondens .tk)nOl generalguldellneafor protec- tknt ol workers horn tratomisalon of blood-borne pathogens. derived from the Joint Advisory Notice of she Departments of Labor and Health and Human Services (6). is provldcdlnectk)fl Ill (see page I I) . C. Mode. nd Risk of Virus Transmission in the Workplace wound. nonintact (e g,ch.pped,sbr.drd.w ep lng.ordeimathl lc)1 1 1 t1.0r mucous niem- brand to blood, blood contaminated body fluI . or concentrated virus Blood Is the single most Imposlant source of WV and IIBV In lbs worbptsct setting. Protection mcuusea against IliV and IIBV for woekers should focus prienaillyon preventing these types of exposure’ to blood so well — on delivery of I WV vaccination. The risk of hepatitis B lnfectlonfollowlflghPar eflt erat(l e • needle stick or cut) exposure to blood is directly proportional to the prob.blllty that the blood contains hepatItis B surface antigen llBsAg). the immunity stetus of the recipient, and on the efficiency ol transmisslon(l). Theprobabitityof thesourceol lhebloodbdlflgHllsAg positive varies from ItoS per thousand In the general population to 5%-lS% In groups at high risk for HBV Infection. such as Immigrant. from areas of high endemicity (China and Southeast Ailasub SaharanAftlCa,rnOst paclflcislan& andthe Amazon IlasIn);ctlents Ininstitu tions for the mentally .ct.,ded intravenous drug users, homosexually .ctlve male., and household (sexual and non sexual) contacts of IIBV carriers 01 persons who have not had prior hepatitis B vwxtnationot postelposwe prophylaib. 6%-3O% of persons who receives needle stick exposure (roman lUDaAg-poaltlse individual wilibecome Infected (7) The risk of Infection with HIV following one needle stick esrosu,e to blood from a patient known to be Infected with lily is approxImately 0 5% (4.5) This rate of hans- mbslonbconskldiatrly lower than that for HBV. probably ma result of the signhllcantly lowerconcent,atlom0fvir ad thehPbood0f l-ilV lnfectedpei.ons Tablet (seepage 31) presents theoretical data concerning the likelihood of iniection given repeated needle- IllVsetoatatusis unknown Thoughlnadequateiy quentilled. the risk from exposure of nonlntacl skinor mucous membranes is likely tobe far less than that from percutaneous inoculation. U. Transmission of hepatitis B Virus to Wo,kers I. health-care workers In 19*7, the CDC estimated the total number of I IBV infections In the United States 10 30,O0pCry1,witppro1 tdly75.O 25 0 l infrcledpersonldevel0P- ing acute hepatitis 01 these infected Indlviduab. lI.000-30.OtXI (6%-iU%) will become IIBV canlen. at risk of developing cluonic liver disease tchronic active hepatitis. cirrhosis, and primary liver cancer), and infectious to others CDC ha. estimated that 12,000 health care workers whose )obs entail exposure to blood become infected with tiHY each year, that 500-600 of them ate hospitalized as a result of that Infection, and that 700-1,2(X) of tho,e infected become IIHV carriers 01 the Infected woikers, spproilmatety 250 wIll dIe ( 12-1 5 from fulminant hepatitis. l7O_2UUfromcIrrhosis,aM40- 50 fr0m re.1 r) Studies lndlcatethat Atthoughthe potentialfor I WV tr.n.mbsionin the workptacesettIflIisgrdtthar f0r HIV, the modes of transmission for these two viruses are similar. Both have been trans misted inoccupatlunal s ettinpoitlyby percutaneous inoculatlonor contact with anopen ------- S MMWN Vol ISIN. IS Jun. U. lIfl MMWR 7 lO%-30% of health care or dental worke,s show serologic evidence of pest or pie. sent IIBV Infection. 2. Emergency medical and publlc safesy workers Fmergencymedkatwoike,s hsveanh,crearedrhk forhepatith BInleclkin(8,9,1O). Thedegreeolrhkco,relstes wiIhthefrequnqandeJtentofbloodeaposuredu, She conduct of work activities. A few studies are available concerning thkof HBV lnfccl i onI o rothergeoupsofpabilcsafe t,wo,ke,s(Isw.eflfO,ctmentpefsoflnep 5 coriecltnnisi Iacfflivw ,hCfl),bu 5 reports that Icnpubftiheddonnidocuni,ni any increased ilk for HBVInfedkm(I j2IJ) I4eve,thelesa, In occupational settings In which workers sarybe routhielyesposedto blood or other body (tulsis described below, an Increased ibis lot oncupatlonsi acquisition of HBV Infection mint be esstimad to be preseaL 3. Vacetnatk. for hepatitis B vicmn A safe and effective vaccine to piewnt hepatitis B tme been avaIlable lime 1952. Vaccination is. been recommended for health care workers regularly esposed to bloodandotherbody Ilukie potenthltycontasn lnatcdwfth VlBV(7,l4,1 ). In 1987, the Depaitmentof IleahhandHum.nSe vkesandtheDepartment oflaborstated that hepatitis B vaccine should be provided to aS such workers at no charge to the worker (dJ. Avblevsstlmulatect lvelmmunh yaga lnatllflV lnfecsk,nandp,ov ldeo v er 90% ptotedkm against hepathis B lot 7 or more years following vaccInation (7). Hepatitis B vaccines ahoa,e 70-88% effectlvawhenglvenwhhln I week after IIDV eaposure. HepatItis Birmtmuneglobultn(HBIG ) .aprep.rationofhmnunoginbufln w4thh lghkveholanlibodytoHBV(.n ll-lIBs), provides temporary passive prolec. lion following esposure to HBV. Combination treatment with hepatitis B vaccine and HB 1O hover 90% effectIve In preventing hepatitis B following a documented elposure (7). E. Transmission of human Immw iodeflclency Virus to Workers I. Heahh.care workers with AIDS Asof September 19, 195$, a total of 3.182(5 t%)of6I .929adults with AIDS, who had keen irnorted to the CDC national aurvrillanrr . 5 1 5 cm .nd for whom occun.. incomplete for 2$(17%) because of death or refusal lobe Interviewed; 97 157%)are still being Investigated. The remaining 44 (26%) health care workers were inter. viewed directly or had other follow-up inlormatlon available The occupations of these 44 were nine nursing assistants (20%); eight physicIans 115%). four of whom weresusgeom;eighthoisaekeeplngormalntenanoewotkerat I$%);thnurses( 14%); (2%); one paramedIc (2%); one embalmer (2%); and (our others who did not have contact with patients (9%). Eighteen of these 44 health care workers reported psrentersland/o ,othernon-needle-stkkespoauretobloodorothcrbodyfluidalrom patients in the tOyea.s preceding their diagnosis of AIDS l4oneof these elpeaures Involved. patient with AIDS or known IIIV infection, sod I IIV serocxmvcrvion of the health care workcs war not documented followings specific esposure. 2. human Immunodeficlency vinsa transmission In the workplace Aaof July31, 1988,1,201 heahh-cate workers had been enrolled and tested for IIIV .nt lbodyinongo lngCDCsurve lllanceofheahh-ca rewo rkcrseiposedv laneed lestkk or splashes to akin or mucous membranes to blood from patients known to be HIV.infccted (16). Of 860 workeis who had received needle-stick Injuries or cute with sharp objects (Le , parenteralespoaurea) and whoseserum had been tested for HlVantlbodyst least i5odaysafterespcsaure. 4 were positive, ylekiingaseropieva- knee rate of 047%. Three of these individual eaperienced an acute rctrovlrat syndrome associated with documented seroconversion Investigation revealed no nonoccupatkrnalrbkfactonfortheaethreeworkers. Serunicotkctedwlthtn3odays of esposure was not available from the fourth person. This worker had an I -Il V-seroposltlve sejual partner, and heterosexual acquisition of infection cannot beesciuded Noneof She IO3wo,kerswhohadconlamlnalionofmucousmembsanea or nonlntact skin and whose serum had been tested at least I SO days after exposure developed serologIc evidence of HiV InfectIon. Two other ongoing prospectIve studies assess the risk of nosoconmlat acquisItion of lllVlnlecttonamonghealth-c .reworkerslfltheUnttedStstel Ajof April 1988,the National Institutes of Health had tested 983 health care workers 131*11k &,cu- mentedneedk.stkklnjurkasnd345kealth -c*re *orkerswhOhadsUslaincdmUC nl n- membrane esposures to blood or other body fluisk of III V-Infected patients; none had seroconverted (I?) (one health care worker who sut,scquentty c.pcrknccd an occupational HIV .eroconverslon lies since been reported from MIt 1181) As of March IS, 98$, a similar study at the IJnlvcralty of California of 212 health care workers with 625 documented accidental parenteral esposures Involving ltlV-ln- fected patknla had identified one seroconversion following a needle stick (19) Prospective studies In the United kingdom and Canada show no evidence of ISV tional Information w available, reported being employed in. health care settIng. Of the health-care workers wish AIDS. 95% reported hIgh-rIsk behavior; for the remaIning 5% (i69 workers), the means of ISV acquisition was undetermined. Of these 169 health care workers with AIDS with undetermined risk, information is ------- S MMW Jun.fl. 1 5 5 5 v.ausN $• MMWR srammhlkrn.mong22oheafth carceorkeri wlthparcntersl, mucor membrane,o, cutlneot eipo.we. (20.21). in addltkrn to the hesltheese woiker. enrolled In these kniglludlnal surveillance studies, case biSons. tgve been publhhed In She scientific literature for 19 liv. Infected hesith-eate workers (13 wIth documented scroconversion .nd6 without documcnledseroconver.loa) l4oncof these rkersrcportednonoccupatlona l,lsk lactoes (see T.ble 2, psgca 32. 33) 3. Emergency medical sender and public safety worker. In sddlikrn So the one paramedic with undetermined rirk dlsca*scd above three publIc-safety worker. lsw.enforcrmcnt oflke,s).re clarsilledlnthe undetermined s l am group Follow-up Investigations of these worker. could not determine con. chaively If lily Infection wm ac u1red dunlni the performance of job duties. II. Prtnetph.ol Infection Control and Their Application to !mergency and Publk.Satety Woebere A. Oeneral infection Control Wlthtnthehealth caresettlnLFneralbncofltroiprOcedUre.hevebcendeve lopod to ntltdmlie the rbk of patient acquiltionol Infection from contact with cont.mlnated devices, objects, or surfaces or of tr.mmhekm of an Infections agent from health care worker. to patients (1,2.3). Such procedure. abo protect workeri from the uk of t,eoondng Infected General InfectIon-control procedures are designed to prevent trans. nthalonof a wide range of nrlcrobloiogkal agent, ant to provide .wkie margin of safety In the varied situations ennountered In She health-care environment. General infectlon-conurol principles are applicable to othcn work environments where workenconlaclother Indlvlduabandwhere trammbsbno( Infectionsagenti mayoecur. The modes of tranambalon noted In the hospital and medical office environment are observed In the work situations of emergency and public safety worker., as well There- fore, the principles of InfectIon control developed for hospital and other health-care settings are sho applicable to these work sItuations Use of general Infection Control measures. adaptodtothe workenvlronmentaofemergencyandPubllc safety worker., b important to protect both workers and indlvlduabwfthwhomtheyworkhOmavsrlety of Infections agents not juat IIIV and ISV. Becanse emergency and public-safety worker. work In environments that provide in- herently unpredictable iii.. of eaposurea, general InJection-control procedures should be adapted to these work sItuations Exposures are unpredictable, and protective mea- sures may often be med In situations that do not appear to present ilak. Emergency and public safety workers perform their duties In the community under estremely variable conditions; thin. control mamures tint are sImple and uniform across all sItuations have the greatest likelIhood of worker compliance. Admlnlsttative procedures to ensure compliance sko can be more readily developed then when procedures are complex and Hghty variable. B. Universal Blood and Body Fluid Precautions to Prevent Oceupatkrnal H1V and IIBV Trammialon In 1983. CDC developed thestrategyof “tuihersal blood and body fluid precautions” to address concerns regarding tran,mbslon of IIIV In the health care settIng (4) The concept, now referred to simply as unlversal precautions” stresses that all satlenla should he assumed to he InfectiouS fur fflV and other blood-borne pathoantil In the ho.pltslandothcr health caleaettlng.”ufllvcrulpreCaUtiofls” shoul.Jbcluilowed when worker. are exposed to blood, certain other body flukie (smnlotk fluid, per Icardisi fluid, peritoneat fluid, pleural fluid, synovisi fluid, cerebrospinal fluid, semen, sod vaginal secretions), or any body fluid vblbty contaminated with blood Since thy and IIBV ------- I. MMWfl Jun. U. ime Vol SuN. 1 . 5 MM* it timwmtasion ha. not been documented from elposure to other body liukie (feces, mail aecretk,n., sputum, sweat, tears, urine, and vomilto), unlve,..l precautiona” do not apply So these flulč. Universal precautkuw abe do not apply to saliva, except in the dental setting, where sally. h likely So be contaminated with blood (7). For She purposeof thiedocument, human elposwebdellnedasarntec l wtthbloodor other body fluke to whkhw i lve rsa l pr ecsutk m aspp l y through percutanco tatlon oe contact with n open wound, nonlntact skin, or murow membraneduring She pester. m.iice of normal Job duties. An “exposed worker” I defined, for the purposes of thh document as an Individual exposed , as described above, while performing noimat Job duties. The unpredklsble and emergent nature of exposures encountered by emergency and public which are not Isazsrdma very difficult midoftenlmposalble. For example, poor lighting mayllmlt thewosker’ssbilitytodetectvbibleblo din nitiworfeces Therefore, smaredncs ci matinees in flies daffoubeiworn fluWtv a ea isdif flc idLi l nut ._________l.._ __ — a-— as s__s _.• a__ta a - — - — - S - spplk.tion prhidpksof 5.1 pracaulkiru to ihealtimtk,nunmuntered by these workers results In the development of guidelines (lined below) for work proc. ticea, use of personalprotectlveequlpment, sMother protective measures. Tomlnbnlze the rIb of acquiring HiV and HBV dwing peciormance of Job duties, emergency and puirk-safetyworkenhoueprotededlromeiposuretobk,odandother body fluids drcunwtanmsdkute P tecllonennbeach ievedth,ouah.dherer ice towo,bnractkex designed to mininthe or eliminate exposure and through use of personal protective equipment (Lc.,g l oves,mmbs.andpmtsetlvedothlng) ,whkh provideabarrier between the worker and the exposure source, In some sltuatiom, redesign of selected aspects of the Job through equipment modificatloiw or environmental control can further reduce viek. These approaches to prbnary prevention should be mcd together to achieve mail. mat reduction of the ilk of exposure. lfeiposursof.nlndlvidualwoskeroccurs, medlcalmanagement ,conshllngofcolledk,n of pertinent medical and oecupstlonsl hietory, pro,bkm of treatment, and osumdling regarding future work and personal behaviors, may reduce riek of develophigdbcase as • result of the exposure epbode (22) Following epbodk (or continuous) exposure, dea,ntaminatk,n and di.lnfecikrn of the work environment, devices, equipment, and doihins or other Intia. of ntiaonat niotective eauinnirnt can reduce subscuucnt ilk of Ill. Employer Respoualbllltiee A. General Detailed recommendations for employer responsibIlItIes in protecting workers from .cquhitlonof blood bornedbea.eslntheworkplaet havebeenpublished inthebepart. mdntofEborandDeDaftn l entofHe 5ithafldHUmanSe s10ifltAdchor 0 an1d follows series of steps: I) classification of work activity. 2) development of st.ndard operating procedures. 3) provlknof traingandeducation. 4) development of proce. dines toerisureand monitoroompllsnce,andS)worklllace redesign. Ajelint .tep.eveiy see Table 3, page 34). I inployeis should make protective equipment available to all worker . when they are engsgcd In Category I or Il .cllvitks. Employers should ensure that the .pproprlate protective equipment bused by workers when they perform Cate- goryl activities. As . e nd step, employers should establbh $ detailed work practices program that includes standard operating procedures (SOPs) for all activities having the potential lot exposure Once these SOP. are developed, an initial and periodic worker education program to assure Iamill . rlIy with work practices should be provided to potentially exposed worker.. No worker should engage In such tasks or activities before receiving training pertaining to the SOP., work ptact , sod protective equipment required for thattask. anrpkio1pcrsonalp,otedivcequipnientforthep1eh01Plt5l5cttmf$( i0ed ass setting where delivery of emergency health care tales place away from a hospital or other health care seating) are provided In Table 4 (page 33j (A curriculum for such training progranw I being developed in conJur ictkm with these guidelines and should be corwulled for further Information concerning such training programs) To facilitate and monitor complience with SOP., sdmlnbtratlve procedures should be developed and records kept as described In the Joint Advbory Notice (6). Employers should monitor the workplace to cosine that required work practices are observed and that protective clothing and equipment are provided and property wed The employer should maintain records documenting the admlniatraiive procedures used to classify Job activities and copies of all SOP. for tasks or activities involving predictable or unpredic- table exposure to blood or other body fluids to which universal precautions apply In addition, training records, Indicating the dates of training sessions, the content of those training sessions along with the names of .11 persons conducting the training, and the names of .11 those receiving training should also be maintained. ing the work environment which will reduce exposure rIL Such approaches are desira- ble, since they don’t require individual worker action or management activity For ..i.mnl, irikandcnrlrctionslladhitk ShOUWhaVeda SSi IiCatlOflPrOcett Iu1d1 that require exposures. Proper dhpos.l of contaminated waste ha. similar benefIts. ------- I? MMWa .IuaslI.ISIS V .1 NINa MMWR I I — . s •flc 1 .t 5 .Iwu. ,. .,.— — to attack correctional facility stall with the Intent of traiwmllling IliVot I WV B Medk.l In addition to the geeral ,e onalbliullos note4 above, the employer h the specific reapomlbwly to make available to the worker a program of medkal management. 11th program b designed so provide (or the reduction of rbk of infection by HBV and for aruiwefing woiken a,nctmtng hsuea regardIng lily and HOV. These services should be provided by. Ikemed health professionaL All phmes of medical management and c,ounseUnishouldenaure thaItheiidelUia ,Ofthewotke1, fh5n *W5ta bpsoiectd. I. llepsthhBv.cdrmtk’fl AU workers whose jobs involve participation hi m b or .ctlvlllcs with eiposwe to bloodorothei bodyflukiatOwhkhUflhoflalP Iapply tmdelinedabOveOfl page 9) should be .acehwted with hepalIth B vaccine. 2. Management of percutmmot eaposur. to blood and other Inlacliour body flukia Onceanelposute hat xvrtesi(.deflncdabovcoflpar IO).abloodsam ple sho uid bedrawnaIteIameflth0bbom 1 u 5 0o nbd eliclency virus (IIIV antibody) Local lawn regarding coment for testing source Individoab should be followed. Polkics should be available for testing source ln dI,kiuah In situatiotw where cement cannot be obtained ag • an uncoosdous patient) Teasing of the souros Individual should be dons as. location where ap propriate pretest wumctlng b avsllsbk poatteal coumeflng and referral (or treat. ment should be provided. Is h estremely Important that all IndMduals who seek iomultallofl lot any I II V.related concerns receive coumefing as outlined In the ‘Public I lealthServke Ouldelinea for Counseling and Antibody Testing to Prevent IIIV Infection and AiDS” (22). a. Hepatith B virus posle .poaure msnsgement For aneapoturs toa source Individual found lobe positive for HBIAg. the worker w 0 h flotprevi beengivenhePauith Bvscdne,houMreceh’c the vbcclne scales A single dose of hepatith B immune globulin (IIBIG) b .bo recommended. If thb can be given wIthin? days of caporule For c i. polules (roman lIBsAg positive source to workers who have previously recelvedvaclflc.thet1P001r5h0 be1ested lo,snilbodytohepati lb Bsurlaceafltlgen(anti IIB.,.andglvCflOflCdOICOf vaccine andonedoic IOSRUbyRIA,negatlvebyE lA) (7). - - - If the source individual I negative for liBsAg and the worker has not been vaccinated, thir opportunity should be taken to provide hcpatltb B vacelna- haiL lithe source Individual ref ure, testing or he/she cannot be kientilled. the unvacdnaicd worker should receive the hepatllb B vaccine perk. IlItiO administration should be considered on an Individual bash when the source Individual I known or surpected lobe at high ilk of IWV infection Man agementandtrealmenl. If anyoiprevloualyvscdnated workeis who receive an eapeawe from .souice who reluses testing orb not identifiable should be IndIvidualized (7). b Human bnmunodelklency vIta posteiposure management For any eaposule los source Individual who has AIDS, who I found lobe positive for IIIV Infection (4), or who relines testing, the worker should be counseirdregardlngthe rbkoflnfectlonandevslualeddlnkailyandscrolo- gkally for evidence of HIV Iniectionessoon as possible after she eiposurc. Inv lewoflheevolvtngnalureollllVpoalcipoauiemaflagement.the health. care provider should be well liformed of current PHS guidelines on subject. Thcwo,kctshouldbeadvbedtoreportsndieek niedlcalevatuatlon (or any acute febrile illness that occurs wIthin 12 weeka alter the eaposure. Suchsnwnns.p .rlk i arlyofledrdei lzedbyre vei.r s sh.OiIyiflPhaden O- pathy. may be Indicative of reotnt HIV Infection Following the initial tess at the timed eiposuse.seronegalive workcrsshouldbe retcsted6 weeks, Il weeks, antl6montlo alter eiposuze ho determine whethet tran,mbakin has oecwred Du,tngthkl000w-uppcrlod(eapedally the (1. 16- l2weekiaftcr eiposwe,whcnmost fectcdpersoiwareeipechedtoscrocunvert ).eipoied worke,sshouldlollow U S Pubtlclle.IthServlce (PuS) recommendations for preventing tranambilon of IIIV (22). These Include rdraInlng from blood donation and taing approprhle protection duilngsciual lniercouisc (23) Dwlngailphascsof(OIIOW-Up,I1 hvltalthat workerconlidentlallsybe protected. If the source IndIvidual wes tested and found so he seronegailve. baselIne testing of the eaposed worker wi;h follow-up testing 12 weeks later may be peilormed U dralred by the worker or recommended by the health case provider ------- I I MMWR Vol hub SI MMWR Is follow up should be kalividualked Serologic testing should be node avail •bk by the employer to at) wo,kei. who may be concerned they have been Infected with lilY Ihiough an occupational erpoaure as defined above (see page 10) 3 Management of human bites On occasion, police and correctional facility officers are inientlona lly bitten by stwpectaor prisoners When such bile. occur, routine medical and surgical lher.py lincluding an assessment of tetsnua vwxlnation stal in) should be Implemented as soonas possible, since such bites frequently result in Infection wlthorganbnnothes than tliV and 1IBV. Victims of bites should be evaluated as deicilbed above (see page Il) for erposure to blood or other Inlec tloi n body flukie. Sallvaof some penornlnfectedwlthHBV hasbeenshowntoconisln HBV.DNA at concentrations 1/1.000 to 1/10,000 of that found in the Infected person’s serum (3,24) IIbaAg positive saliws has been shown lobe infcctknm when injected into esperimentat .nimais and In human bite eipuaures (23-27) However. HOIA5. positive uiiva has not been shown to be inleciloin when applied to oral mucous membranes In esperimentalprimate studies (27)or ihroughwntsmln.lionof musi- cat Instruments or cardiopulmonary resuscitation dummies med by HBV carriers (28.29). Epidemiologic studies of nomeau.l boinehold contacts of Ill V-Infected patknt..lnc ludingseveralsms i laedesinwhlchH lVtrammh h lOnfa lkdto occ llratter bile. or (ler percutaneots Inoculation or contamination of cuts and open wounda with s.ltv.froin Hi V.Infected patients, suggest thai the potenlial for salivary tram. mbskmof HIV is remote (3.30-13). One case report from Germany has suggeated the possibility of transmbslonof HIV na hotsehold setting from an infected child toe sibling through a human bile (34). The bite did not break she skin or result In bleeding Since the date of aeroconversion to HiV w not known for either child In 4 DocumentatkmOf esposure and reporting As pert of the anti Identlal medical record, the clrcunwtances of espolure should be recorded Relevant Information includes the activity In which the worker was en- gaged at she time of eaposuse. the extent to which appropriate work practices end protective equipment were med. and. description of the soucoc of exposure. Employers haves ,espomnlbiUty under various Federal end state laws end regulations so report occupational Illnesses and injuries Existing program’ in the i4atlonal institute for Occupational Safety and Heaith (NiOSIt), Department of Ikalth end Human Services, the tiurenuof labor Stat btka, Department of Labor (1)01); and theOccupatlonaiSafcl,sfldIle a IthAdmIfl i str l 0I)r 5ud i1d0mm 5tboh i for the purposes of surveillance and other objectives. Cases of Infectious disease, Inciuding AIDS and IIBV Inf ectkni , eze reported to the Centers for Disease Control through State health departments. - 3 Management of HBV. or HIV-Infected workers Transmission of HBV from hesith-care workers to patients has been documented. Suchtr.mmbslonhasoccurreddwhigcertalfltfltcsoflttvslveproCedUfes(e.I ,orai arid gynecokigle surgery) In which health-care workers, when tested, had very high conorntr.tknsof IIBV In their blood (at least 100 millIon Infectious viris particles per mllhtllter,aoonosntratkmn much hlg$ier than occurs with HiV Infection), and the health care workers sustained a puncture wound while performing invasive proce. dwes or had exudative or weeping lesions or mk,oiaceratlona that aflowedvlna to contaminate ltwtnunents or open wounda of patients (33,36) A worker who is liBsAg positive and who has transmitted hepatitis B vInn lo another Individual during the performance of hh or bet job duties should be eududed from the perfor- mance of those job duties which place other individuab at risk for aa uisitlon of hepatitis B infection. Workerswithtnlpairedimmunesyltemsrc sUtttflg fromHlVlntectkinorotbercauscs are at increased rukof acqulrlngorelperkndngaeilouscomptlcatk)naOl Inlectlotn disease. Of particular concern is the risk of severe Infection following exposure to other persona with infectious diseases that arc easily transmitted If appropriate precautions sic not taken (e g • measles. vericella). Any woiker with an Impaired immune system should be counseled about the potential risk associated with provi- ding health care to persona with any transmissible Infection and should continue to follow existing recommendatlomn for inlectloncontrol to minimize risk of exposure to other Infectious agents (2,3) Recommendations of the immunization Practices for vaccinating workers with llvc.virus vaccines (e.g, measles. rubella) should aiso be considered The question of whether workers infected with IllV can adequately and safely be allowed to perform patlent-caredutlea or whether their work assignments .houldbc changed must bedetermined on en kidlvidual basis. These decisions should be made by the worker’s personal physician(s) In conjunction wIth the employer’s medk*l advisors. C Disinfection. Decontainlnatkrn, and Disposal Asdescflbedk%Sectlonl C. (see pagel).theofllydocumentedOocUpatlOflhirl 5kiof lllV arid I- WV infection are associated with parenteral (Including open wound) arid mucous membmaneelposUre So blood andother potentially Infectious body flukb Neve,thcless, the precautions described below should be routinely followed. ------- J u N 53 ) Vat 5SINoS I, MM* I. NeedkandShatPsdhPohht MNWw All workeis should take precsulknw to prevent injuries cained by needles, scalpel imtrwnenta . during disposal 01 med needki, and when tiandilng sharp Instruments alter procedures To prevent needle stick Injuries, needles should not be recapped. purposely bent orbmkenby hand. removed (rdm disposable syringes, or otherwise manipulated by hand. After they arc med. disposable syn*ngea .nd needles, scalpel blades, end other sharp itemashould be placed In pundute-teibtat t container, lot disposat the pun e.resnfltaisuh0 k,cstedmclose — practical to the we area leg, lathe ambul.nce or, if sharps are carried to the scene of victim Sothescene.wefl). Remnshie needle shou ldbeleftoflthtsyrlnhl shOuhd be placed na puncture4Csistaflt container (as transport to the teproctssing r 2. Hand washing lands ami other skin surfaces should be wedied Immediately and thoroughly II contaminated wlthbk,Od. other body fluids towtdchuntvtml prec .utkun apply. Or potentially contaminated .rtkirs Hands should sinayl be wedied after glo as are ,emoved .cVefl If the gloves appear lobe intact. hand washing shouldbealmPleted wing the.pp.oprlate fadUbim.surhUtIlityOrtutr00msI k Watelkllafltbeptle hand cleanser should be provided on responding units lowe when hand washing lacllhki s ic not .vsllable. When hand washing facilities are available, wash hands with warm water and soap. When hand.washlflg facIlIties arc not svallsbk. mae a asterlma antiseptic hand cleanser. The manufacturer’s recommendations For the product should be followed 3. CleanIng. dislnfcctlfl$. and aterilising TableS (see pages 36,37) present’ the nscthods and applications (or cleaning. disin- fecthig. .inI sterilIrkil equipment and surfaces In the prehospltal setting These thods abo apply to homaekeepiflg and other cleaning tasks 1’,evlotnly Issued guidelines for heahh4ate workeis contain mote detailed descrIptions (4). 4. Cleaning .nddrcont .mhl atlflg splib of blood ANspUb i oodntamt b5h PP an EPA.SPprOr cdVI cora I.I sol onofhoUsCholdb 1 dh1the following manner while wearing glares Visible material should lint be ,emoved with dis- posable toa’ Is or other appropriate means that will ensure against direct contact althblood i (splashiflgia.fltlClpat proteccyeweMsho m11vlthm an tmperviomd gown or spron which provides an effective barrier to splashes The area should then be decontaminated with an appropriate germicide I lands should SoiledclcsningcqulPmentsbouldsest%ed andmiecontamlflatedot plscedlnaflaPPfOPtieteWnt 5 hsPo1ed0otO1 18 to agency policy Plastic bags should be available for removal of contaminated Demo (tons the site of the spill Shoes and boots can beuune contaminated with blood in certain Instances Where coverings should be comlde,cd. Protective gloves should be worn to remove con. t.mlnated shoe coverIngs The coverings and gloves shouldbe dIsposed of In plastic bags AplastiebagshOUldbe the mesctnekibot thecarwhichbtobe wed for the disposal of contaminated ltenn. Eats. plastic bags should be stored In the police auber or emergency vehicle. 5. Laundry oIactual0neasCir5Ian iuu3 ’ e ’ catlons. hygienic storageand proceuingof clean end soiled linen are recommended. L au,yfaCllit i eand/ 0 fseMce, 5h0ul m 5&routindl7aval YtbeP0Y Soiled linen should be handled little as possible and with minimum agitation to prevent gross mic,oblslcontsmtflatlOli0f the sir and of persona handling the linen Misolledlinenshouldbe baggedat the location where it waS wed EJnensollcd with bloodshoUldbe placedsndtransportediflbaP that prevent leakage F’Iormst laundry cycles should be wed according to the washer and detergent manufacturers’ recom mendatiota. 6 i)econtatnlnatk)n and Iaw,derlng of protective clothing Protective work clothing coniaminated with blood or other body fluids to which universal precautions apply should Lie placed and transported in bags or contains that prevent leakage Personnel Involved in the begging. transport. and laundering of contaminated clothing should wear gloves Protective clothing and station end work uniforna shouldbe washed and dried according to the manuladuier’s Instruc lions Boots and leather goods may be brwh scrubbed with soap and hot water so remove contamination 7. infectIve waste The selection of procedures For disposal of infective wnite is determined by the rcIatlvc risk of disease transmission end applkstk)flOf local regulations, which vary widely in all cases, local regulations phould be consulted prior to dlapar.l proce- dures and followed. Infective waste, in general, should either be Incinerated or ahouldbedec ofltamin ate 0re poie ass ts,yl andfill lluikbioud, suCIIOfled ------- Is MMWn 5 ). I S I S Vol 15 1W. SI MMWR I. fluids. eretetlona. andsecretions may be carefully poureddowna drain connected to • sanitary sewer, where permitted. Sanitary sewers etay also be used to dbposc of other infectious wastes c .p . U . of being ground and iliohed into the sewer, whets permitted. Sharp itenw uhould be placed in puncture-proof containers and other blood-contamInated beam should be placed in leak-proof plastic bap for transport to so appropriate disposal location. the pstknt has been eared for titouidcsselullyseaichf ot and remove contaminated materIals. Debib should be disposed of a noted above. IV. flr, sod emergency Medical S., . k The guidelines that appear in this section spply to lire and emergency This support personneL Firefighters often provide emergency medical seniors and therefore enmtmter the eaposurn common to paramedics and emergency medical technicians Job duties are often performed in uncontrolled environments, which. doe to a lack of time and other laclora,donot show for auotkatlonof acompleadeclsion -makbig process tothe emer- rncvat hand. The general prlnclpks presented here have beendevelopedfromesbtingprlndpksofoocu- pational safety and health In conjunction with data from studies of health-care workers In hospital settings The basic premise is that worker, must be protected from esposure to bloodsndother poientlaltyinfectlorwbodyflukbinthccourseofthelrworkaCllvitles There bapaudtyoidstaconorrnht gthe,bkstheseworkerg roU psla ce.hOwever,whlChCOmPlk* 1e 5 development of control prinelpies. Thus, She guidelines presented below are based on prin. ciples of prudent public health practice. Fire and emergency mrdkalservkt personnel are engaged In delivery of medical care In the prehospitalsettlng Thefollowlnggukleiinesareintendedtoasslst thesepersonncilnmaklng decisloca conoernins we of personal protective equipment and resuscitation equipment, as well as lot decontamination, dlshifectlon,.nd disposal procedures. A. Personal Protective Equipment Appropriate personal protective equipment should be made availeble routinely by the employer to reduce the risk of especure as defined above For many situations, the chance that the rescuer will be esposed to blood and othe, body fluidi to which universal prec*utloea apply can be determined in advance. Therelore. lithe chances of being esposed to blood is hIgh (e g .CPR. IV insertion, trauma, delivering babies), the worker should put on protective attire before beginning patient care. Table 4 sce page 13) sets Iorthesampksofrecommendationlforpelsonaiprotectlveequipment inthe prchospitai setting; the list is not Intended to be aU-Inclusive. I. Oloves Disposable gloves should be a standard cumponent of emergency response equip. ment,andshou)dbedonnedbyallpersOflfleiplIoI tolnltiatingsnyemergencypat lent care asks involvingesposure tobloodorother bodyiluids to which unlversalprecsu- lions apply. Eatra pairs should always be available Considerations In the choice of disposabie gloves should include desterity, durability, lit, and the taik bcinF per- formed. Thus,there is no.lngk typeor thickness of glove appropriate for protection in allsltuatlons For situations where large aniountsof blood tue llkeiy to beencoun- tcred,it isimportant thstgloveslitttghltyst the w,ist toprevent hloodcontaminatiofl ------- aS MMWn Junfl.iN 5 Vc IflINSS MM ii of handa around the cull For multiple trauma victims. gloves should be changed between patient contacts, If she emergency situation allows theater pcr.on.l protective equipment measures are Indicated for situations where btokenglmeandsharpcdgaserebkel,sobeenoun lered.such.sc xt, i c a s i ngaper,on from an automobile wreck. Structural I I,. lighting gloves that meet the Federal OSlIA requirements lot lire lighten gloves as contained In 29 CFR 1910156 or llstkmnal Fire Protection Aaaodsikm Stans ard *973, Oloves lot Structural Fire Ftghtenpsbooldbeworninanyshuatkmwheassbazpo. toughawlacasare Ilkelyto beenoounle,ed(37). While wearing gloves, avoid handling personal brew, suchmcombs and pens, that could become soiled or contamlimled. Oloves thai have become contaminated with blood or other body Ilulde to which wthcnal peecautkriw apply should be removed • soon as possible, taking ease to avoid skin contact with the esierior surface Contaminated gloves should be piaced and transported In h . p that prevent leakage mid should be diaposed ole., In the ems of tamable gloves, cleaned and dblnfected properly. 2. Mmba,p....ar,ndgowrw Mwha,eyeweat ,andgowmshouldbepresentonallemergencyvehkksthat respond or potentially respond to medical emergencies or victim rescues These protective barrlersshoublbe wed ina rdanceMththelevelofeape.weencountered. Minor loceratlom or small amounts of blooddo not mciii the same extent of barrier r ae as tequimdtorensanguInatingvictltnsormemIvea talalbkedIng Msnagementolthc patient who it not bleeding, and who has no bloody body liulda present, should met rouinquheweofbatrlerprecsutkuw. Masks .ndcyewear (eg safety glasses) should be worn tugeiher,or a lamahield should be med by all personnel prior to any slsuat l onwtsern.phot.csotbkrodorosherbodyllukittow*skhunlve iaalprecaui i om apply are likely tooecue. (loans or aprons should be worn to protect clothing from sphehor with blood. If inrge aphahea or qrantltles of blood arc present or anikip.. ted, Imp omagowiwor aprons should be worn. Aneitrachangeof work clothing sisouk ibe avallabteat all times. 3 Resracftatlon equipment Notrsmmhslonol HBVos HtVlnfectiondurlngmouih to mouthre,uscltstionhas been documented. however, become of the irk of salivary trsmmimlon of other Inlectiomadbeascs (eg, herpes simplex and Nthude mesrin 1 tt idir P and the theore •frmt.kInlIIIVandI iRViianimhalnndu,In..tl llklslventUatk)flOltraUfl%avkuInw, thoroughly cleaned and dbmnfected after each inc according to the manufacturer’s recommendations Mechanical respiratory assirt devices leg, bag-valve masks, oxygen demand valve ,csmadtstors) should be avaIlable on all emergency vehicles and to all emergency response personnel that respond or potentially respond to medkal emergencIes or vIctim rescues. Pocketmouth to rnouth,csusdtationmaskadeslgfledtObOiateemergtn cyrespome personnel lie • double lumen 5 )1 5mw) from contact with vid Inn’ blood and blood- contaminated saliva, respiratory secretions, and vomifta should be provided to all personnel who provide or potentially provide emergency treatment dnlevl(ca be wed once and dbposed of or,lf reusable, ------- Jun. 21. ime vol IN. S• 23 be put on soon N amditlom permit. In e of blood contamination of clothing. sneMra change of clothing should be available at all times 2. cardIopulmonary resuscitation LenforccmentandenfleetioflaIpeiOflfletme5bOco e bd 5tbout infectionwith lily and IIDV through administration of csrdiopuimonasy resuscitation (CPRI. Although there have been tm documented cases of I-IIV irammisrion through this mechanhm,thepossibllllyOftrsmmbslOnOfOlheI lnfectiousdiscaacseibli There- fore. agencies should make protective masks or airwaya available to office’s and provide training In their proper me Devices with one-way valves to prevent the patient? saliva or vomitus from entering the caregiver’s mouth are prelerabie B. law-Enforcement Co,nljerstloin I. Srdmeaanduvide&C handling Crlmhaljmnlkr personnel have potential risk. of aciuirlng liDVor lily infcction througheIposureswbkhoeeWd%flthI5esresan 1 cc handling Penetrating injuries are known tooceur.and puncture wountis or needle sticks in particular pose a h izard during searches of persor .vehklea.o b. and during evidence handling The following precautionary measure. will help to reduce the risk of Infection- • An officer should use greet caution in searching the clothing of suspects lndlvldu.ldiscrctiOfl,baaed on the ckcunntancea at hand.shoulddetcrmine ilasuspecto l prisoner shouldempty his own pockets or ii the officer should use his own skits in determining the contents of a suspect’s clothing • A safe distance should always be maintained between the officer arid the suspect • Wear protective gloves If elposure to blood is likely to be encountered • Wear protective gloves by .Il body cavity searches • lb cation gloves are to be worn when working with evidence of potential latent fingerprint vaiueat the aimescene. theycun be wornover protective disposable gloves when eaposure to blood may occur. • shifts, toaearch hlddenareas Whenever possible, use long-handled nmhrors and flashlights to search such areas (C g • under cut seats, 22 MMWn V. L aw.Inf ,JUNLCt and C.rr,dIetesl.FadhItIOf hh1 Law enforcement and correctional facility office’s may face the risk of eaposure to blood during the conduct of their duties. For eisnmpk, at the crime scene or during processing of suspects. law loreement off b e ets may e ‘ som rbb o tmminated oderm ic needles oiweapolS.Ofbe(mIkd upon to assist with body removal o,rectionml -fsc1lby officers may similarly be required to search prisoners or their eelS for hypodermic needles or wcsporn.or subdue violent and combative inmates. The following section present. inlor matbon for reducing the risk of acquiring HiV and HBV infectionby law-.nIolCemenI ann correctional facUlty officers acursequence of cmnylng out their duties. However, there is an eatremely diverse range of potential situatborts which fore, medjgle*it0(th Untivarual ou r or event. arise. These recommendat should serve an adjunct to rational decision action is required to preserve We or prevent significant Injury. The following guideline. .rc arranged into three aectiona: .sectlon addressing conceriss shared by both law enforcement and correctional facility officers, and two sectknts dealing separately with lawenlotcelnent office’s .nd c rr tlonalfadlhy officers. respectively. Table 4(5cc page 33)contsirn Kkdedelampksof personal protective equipment that may be employed by lawenfotetment and correctional facility officers A Law Enforcement and Correctional F.dlltlea Comiderstbont I Fights and assaults Iaw.enlo,ccmeI%t andcorrection5tf5cllltyo ce ’ s are elposell iou uu.. . tive and disruptive behavior through which they may potentially become eaposed to blood or other body flul containing blood. Behaviors of particular concern arc biting. attacks resulting In blood esposure and attacks with sharp objects Such bchsvlO ’ s may occur In a range of lawenfOrcement situations Including arrests. routine inte,rogatinns.domestkdisPutes,5nd p0rtloM._ 0r tbonal facility activities. Hand to hand combat may result in bleeding and may thus incur agreaterchaflee for blood-boll’s disease t,anambak,n. Whenever the possibility for elposure to blood or blood contaminated body flukis In all easel. estreme caution must be used in dealing with the suspect or prisoner If there is any Indication of assaultive or combative behavior. When blood is present andaaidpectOr an lnmatclsconlbmtive or threatefllflgtOstafl. giovcssh0uklml 5 ------- 24 MUW Jwisfl. 1 5S 1 V ol SPIN. MMWR 2S • I I searchings purse.are(ufl,emptycoflt efltsdilectly Iiompu,sc,by .wnmg ft upside down over .tsbie. • liar puncture prooi cont wrs to store sberp hutrumenta mid dmely masked p 1.5 1k begs to stoic other poschly miptanthwded Itenn. • To avoid tearing gloves. use evidence tqc instead ol metal staples to seal • LoesIpioccdureslore4meh5ndUflhht should be air dried before sealing in photk. h.n Not all types of gloves are sultsble lot conducting searches VInyl or late. rubber provide Nt 1 octionsgslnstsbarpht strumts,afldt h elatet lot puncture. proof There badlrect lrade-oUbetweenleveIof protectkmsnd manipulability In other words, the thicker the gloves, the more protection they provide, but the less eUectlve they .rc hi locating objects Thus, there ft no single type or thickness of gloveapproptiate lot protecilon ln.llsltuatkflw Ofikee.ahouldsclect the type and thickness of gk)ve which provides the best balance of protection and search clii. ckncy. OlikenandahnesCene technklanamsya)flfrOflt unusual hara,ds,eapeclally when the crime scene Involves violent behavior, such as a homicide where large amounts • of blood are present Protective gloves should be .vsllsble and worn hi thb setting In addition, lot very large spur. conskierstbn should be given to other protective clothing, such as oversile. aprons. boots, or protective shoe covers They should be changed II torn or soiled, and siwsyl removed prkw to leaving she scene While wearing gloves, avoid handling penonal Itenn, such — combs and pens, that could become soiled or contaminated Face masks sod eye protection ora lam shield sic required lot laboratory and cvi dence sechniclam whose jobs which entail potential e po,utes to blood via ssplash to the face, mouth, nose, or eyes. Airborne particles of dried blood may be generated when a stain ft sciaped It ft recommended that protective masks and eyewear or lace shields be worn br labor. toryor evidence technicians when removing she blood stain (or laboratory analyses. objects e,personnelshOuidbeakrtbor thepzescflceOlUhsrP i ,...i ..n.ti aanalb.ornthershatP 2 Handling deceased peruorn and body removal Fordctcctlvcs. invcstlgstors,evldcnce technkisna,andothcrswhomayhavc to touch or removes body, the response should be the same as (or situations requiring CPR or first aid: wear gloves andoover aficuta arid abrasions tocrcate a barrier and care- lutly wsshslieiposed sreslteranycont .ct wish blood. The p,ecautions to be used with blood and deceased person. should abe be used when handling amputated limbs, hands, or other body parts. Such procedures should be followed after contact with the blood ol anyone, regardless of whether they are known or suspected lobe infected with lIiV or HBV. 3 AutopsIes Protective nwaks end eyewear (or (ace shields), laboratory coats, gloves, and water. proof apmmshouldbewornwhenperfosmingoraltendlngall.utopsles Atlautopsy materlslshou$becomldered lnfectkunlor both HIVsndHBV Onlookeriwithan opportunity (or eaposure to blood splashes should be similarly protected instru meAts and surlsces contaminated during postmortem procedures should be decon. tamlnaledwlthanappropsiatechemicllgermkide(4) Manyiaboraiories havemore detailed standard operating procedures lot conducting autopsies; where available, these should be followed. More detailed recommendations (or health-care workers in this setting have been published (4) 4. Forensic laboratories fflood Irom all individusk should be considered Infective To supplement other worksiie precautions, the following precautions are recommended (or workers In forensic laboratories a. All specimens of blood should be put In a well constructed, appropriately labelled container with a secure lid to prevent leaking during transport Care should be taken when collecting each specimen to avoid contaminsling the outikleol thecontalnersndo( the laboratory lorm . mpanylng the specimen b All persona processing blood apedmern should west gloves Maskiand protec- tive eyewear or lace shields should be worn If mucous membrane contact with blood ft snilcipated (e g ,removing tops from vacuum tubes) I lands should be wbcd alter completion of specimen processing C- —— a--— — — flS_.__I___I___S __.I__ _ _I_ _,.._M_._ —— gical culturing.. biological safety cabinet is not necessary however, biological safety cabinets (Class I or Ii) should be used whenever procedures arc conducted that have a high potential for generating dropleti These indude activities such as bkndlng, sonicating, and vigorous miring ------- MMwa Jun. fl imo V Ol 3I II. S.• ‘7 d. Mechanical plpettlngdevkiea should be used (or manipulating all liquids In the laboratory. Mouth plpetllng must Aol be done. C. I. U.e ol needle. and syilngc should be limited to .Ituatkins in which there is alternatIve, and the recommendations (or preventing injuries with needles out- lined under wilve,ul precautions should be followed. Laboialorvwo,kawfscessbouldbeckanedo (vblbIe mate ,Iabandthendecon. laminated with an apjwopriate chemical germicide sfterasplllof blood, semen, or binod-axdandnated body fluid and when work activities .rc completed. • Contaminated snaterlab wed In laboratory teal, should be decontaminated • bdoe reprocessing or be placed in hap and disposed of In accordance with Insthutlooal and local tegulelosy policies (or disposal of Infective waste. Penetrating Injuries are known to occur in the correctional facility setting, and puncture wounds or needle stick. In psiticuler pose a hazard during searches of prisoneraorthelrcelis. Thefollow1ngp,ecautlonarmeasureswIflheIPt0Kd tha risk of Infection: • A correcilonal-facdlty officer should use great caution In searching the clothing of prisoners. Individual discretion, based on the circumstance’ at hand, ahouki dctennlne lie prisoner should empty Id. own pockets or It the officer should tar itis own skis In determining the contents of a prisoner’. clothing. • A safe distance should slwaye be maintained between the officer and the prisonel. • Alwayscarrysflashllght.evendurlngdayllghl shlfts,touearchhlddenareiia Whenever possible, we long handkd mlrro,. and flashlights toaearchsuch areas (eg • under commodes, bunks, and In vents in jail celis). • Wear protective gloves If elposwe to blood Is likely lobe encountered. • Wear protective gloves (or all body cavity searches. Not all types of glove. are suitable for conducting searches. Vinyl or late, rubber glovescanprovldeflule,lfany.prolectlon.gslnataha,p lmtrumenia.andtheyare not puncture-proof. lbereis•d lrecttrsde.of(betwecnkvelofprotedionandmanlpula. bully. In other words, the thicker the glove.. the more protection they provide, but the less effective they are In locating object.. Thia, there is noalngk type or thick. nessol glove appropriate (or protection in all situations. Officers should lelect the typeandthkknesaofg l ovcwh lchplov i desthebe.t b atanceo(proteci i onandam,ch elficlency. 2. Decontamination s-wi disposal Prisoner, nasyspit atoflkenanduhmw(ecea; sometimes thesesubilanoes have been purposefullyo,ntaminated with blood. Although there are no documented cases of IUV or HBV transmission In this mannerand transmission by this route would not becapected Iooccur,othe ,dbeasescouldbei ,ammltted. These mate.labshouldbe removedwith. paper towelafterdonnlngglovea,andtheareathen Ieoontamlnste4 with en appropriate germicide. Following clean-up, soiled toweb and glovci should be disposed of properly. is. Scientific equipment that is. been atatanthiated with blood should be cleaned to the macufactusci. I. AU persons should wash their hands after completing laboratory activities and should remove protective clothing before leaving the laboratory. Area posting of warning signs should be considered to remind employees of continuing hazard of htlcctlois disease transmission In the laboratory setting C. Correctional Facility Considerations I. Searches ------- MMW 2i anI fl tNS VI. leisrencan (1a,ner iS. Fevero MS OuldeIlnelOt 19*5. Atlanta Public Heshh ServIce. Centers for Dbeasc Conttol, 19*5 BUS publIcation no. 99- I I I?. 2 OarneriS.SimmonaBP flflefO,h0I tionp opitala. Infect Control 19*3,4 (suppl) 245-325. 3 WilIlaim WW. OuldeUne (or Infection control In hospital personnel. Infect Control 19*3. 4(auppl)326- 49 4 Center. for Diae.ae Control. kecommend atkflw (Or preventIon of IIIV transmhakfl in he.ltb.C*rSKttlIlP MMWR 19*7; 36 suppl2S). S Centers for Diseme Control. Update: Universal prec.utkna (or preventIon of aranambal0nOlhU ’ ’ t ’ Bvlrua.afld0ther0 0t pathogena In health care eUlnp MMWR *9*8; 37:377-382,387 6 U S Department of Labor. U S Department of Health and human ServIces. Joint AdvNory Notkc: protectk)fl spinal occupStk)nb* eaposure 10 hepatItis B vina IHBV) and human lmmunOdeIlcIeIKY ,t,ta (HIV). Federal Register 19*7; 52:41*18-24. 7. Centers for Discue ControL , ccommendstkrna Inc prote lion q u a t viral hepatitis. MMWR 19*5; 34:313-324,329-335. & Kunches LM.Craven DE. Werner RCI.JscX)b$ LM Hepatitis BelpolUre Inemerlencl medical persoruseF prcvslenct of serologic markers and need for inununIiatk 1 . Amer J M cd 19$); 75:269—272. 9. Pepe PP.. HollInget FR. T,obl CL, Helberl D. Viral hepatitis risk In uiban emergency medical services personnel. Anak Emergency Med *9*6; lS(4):434-45 Ift VaktUUeIST . Hook EW. Copus MK. Corey L OccupatIonal eaposure to hepatitis B In paremedlol. Arch Intern M cd *9*5; 143.1976-1977. I I. Morgsn-CeP 1 P. I lurbon P. 1 -lepatllb B markers In Lancashire police off kers. EpIdemlol 101 *9*8. 100:145-151 12 I’etetklil M.CrSWIOId RI. Hepatitis B vaccine for police forces lLetterP Lancet 1986; 2 *458-59. I) Radvan Oil. IIewsot% P0. Berenger S. Rrookman Di The NewCaStle hepatitis B outbicak ob.ervetk)na on car.C. management, and prevention Med I AWt,alla *9*6; v .a 881N0 S• 14446 1-464. II Center’ for Disease ControL InactIvated hepatitis B virus vaccine MMWR 1982; 263*7-322.327-326 Ii. Center’ for Disease Control. Update on hepatitis B prevenuion MMWR 19*7; 36-333-360,366 16. Marcus Rand the CDC Cooperative Needkstkk Surveillance Oroup SurvclUanc’eof health eare worker’ eaposed to blood from pstlenta Infected with the human immnunodelkiency virija N EngI I Med *9*8.319 11*8-23 *7 Henderson Uk. Fahey RI. Sash Al. Schmitt JM, Lane IIC Longitudinal assessment of rkkforoecupatlonaI/n0mlaltran’m 1b0f hunranImmunodefkkflCY 1IiU5. type * In health care worker’. Abstract p634; presented at the 1988 ICAAC Conference, New Orleam *8 flamesDM IlealthwovkerlSndAlDS Questlo rwpelsbt Science 1988.241161-2 *9. Oerberding IL UtteflCO, Chamber’ hF, Moss AR, Carbon I. Drew W. Levy I, Sende MA. Rbkofoccupation.li1iVtr 5mm nt7 th careworkeri FoHow-up Abstr.ct S 343; presented at the *9*8 ICAAC Conference. New Orleans 20. Heehh.ndWel la,eCSflada Natlonalsu,velIlstlCe programonoccupittIOnaICIPOaUtes to HIV among health care workers In Canada Canada Dis Weekly Rep *987; 13-37:163-6. 2*. McE oyM.POftCf K,MofllmerP,SimmOM N,ShenaonD prospectiveatudyof clinical. Inboratory, and ancillary stall with accidental esposures to blood or body fluids (rum patients Infected with lily, Br M cd 1*987; 294 *595-7. 22. Centers for Disease Control Public health Service guidelines for counseling and antIbody testing to prevent HIV Infection and AIDS MMWR 1987; 36.509-315 23 Centers for Disease Control Additional recommendations to teduce aerual and drug abuae.relatcdtran’mis*IofloIh ii T.tymphotropIC virur type lil/lymphadcnopathly. associated visa. MMWR *986; 35.152-35. 24. Jenison SA, Lemon SM. Baker IN. Newbold JE. Quantitative analysis of hepatitis B visa DNA In saliva end semen of cluonicaUy Infected homosesual men I Infect Uls *987; I56 299-306. 25 Canclo Bello TI’, de Medlna M. Shoreyi. V,illedor MD. Schill 1R An lnriiiiitlonal outbreak of hepatitis B related toe human biting cattier I infect I )sr l9 1t2, 146652 6 ------- MM . 1 fiN. MMW SS II 31. 26. MscQ anlr MB,Foi 1 haMB,WofocbowDA. HeputlthBirimmltiedbyahunmnbhe. lANA 1974; 23&723-4. 27. Sazts RN. Snhbhan R. Hancroft W1 AIter HI, IlnipsI.pong N Eapethnental i,aasmbsloo of hepatith B vIne by eeaeoandssitva. I Infect Db 191% 142.67-71. 21. Glue, iS, N.dle, JP. Hepatlib B v*na In. cradiopulmonary resiacftatk,n training une: RMk of •iuwmiskm (romasuzf.cean*Igenposlilvc pulkipani. Asc I i Intern Med 1965; 145:1633-S. 29. OsleiholmMT. Bra .oER.CrossonJT.ciaL tacIioIimbsIonof ii.IhepatIthtype B after oral cqosvre so HBsAg.posltlve saliva. Br Mcdi l979 2:1263-4. 30. LUson AR. Do akeranie uiodes (or ime,m 1on of human hemunodrfkkncy vtna eat? A uvie.. , . lANA 191% 239:1333-6 P ,kdlnGH.SahsmanBR,RogenME et.L LackofIraasmbslonol lfltV.lII/LAV k,Iectkrn to hoiehoM rantactiol patknts with AIDS or A1DS-rc iedrampki with oralrandidlub. N En 6 IJ Med *916; 314:3449. 32. Cusr.n JW. Jaffe HW, Hardy AM. dii Epkkmlology of IIIV hifectkrn and AIDS In the United SIatra Sclenor 1911,239610-4. 33. Jason iN, McDoupIJS. DIxon 0. cii i. 1f1LV.IU/LAV azithody and knmune.tatn of hoinehold nentacti and semml psflne,i of peisom with bemoptW JAMA *91% 255:2 *2—3. 34. Wahn V, Kramer HH, Volt 1, Bdkier HI’, Sccaznplcal B, Scheld A. Hoilsontal i,ansnthslon of HIV Infectirn between two sflIInp Iteticil . LaneS 1966; 2.694. 35. Kane MA. Lattau LA. Ti.umlulonofHBV from dental penonnel So psilenIL JAm Dent Aisoc 1915; I 10.634-4. 36. Leti .uLA,SmIthJD, Williamas DetaL Transmbakmofhepsillb Bvkn whhrcsultant ,cstrktlonofsurglral practice. JAMA *964 235:934—7. 37. InternatIonal Aaaodatkm of Fire Fighters. Guidelines So pievent Scensmbslon of c*nnmunknble diteMe during emergency raze for Ike Ilghtcrs. pasamedim. and emergency medical technicians. Intern.tkmal Association of Fire Fighters. New York City, New York. 1911. VII. Tablu I 11 t!I II !J liii i - ti i 4111 i !! d 9 g9 9 9 A d .1 ------- U MMW Jw ,.2). I SS S Vol IISN. 5• MUWR I) Table 2 III Vial eded health care workers with no reported nonoccupsOonal Ilek (actors and ( i whom e h%storles have been publhhed hi the sdentilic Iheistwe Csees wIth Documented Seroçunver.Ion • AID1 . No(spt ’ kd • Mothu . Lw hei HIV W eawwhs o 1 with he chUlibloud afl body sea,t s TCt ihe othIt dM not wc and o(Ita d m l mlb he. hm _ Iy alIt .-.‘a . Table Z continued. lily Infected health care woikeis with no reported nonoccupatk.nai rha iactors and (or whom e histories have been published In the aclentilic literature Cnoes without Documented Seroconverskrn Case Occupation Country Type of Esposuic Source Country Type of Espolure Case Oeeupatkrn 19 NS 20 NS 21 Itescarchlab worker 22 Home health- care provider 23 Dentist Source United States United Slates United Slates England Puncture wound 2 Needkslkks Nonintact skin Nonintact skin I• 2 3 4 115’ 1 1$ 1 19 113 UnhedStstea United States UnIted Slates UnIted States Needleitiek I leedlestick I lecdlestkk 2 Ilcedleatlcha AlDSpatient AIDS patient AIDS patient AIDS patient, Ill V-Infected patient 3 6 7 NS Nurse Nurse United States England France Ileedlestiek I leedkstkk lleed l e st lck AIDS patient AIDS patient H IV.lnfected patient S 9 10 Nurse Research lab worker Home health- MartInique Uniled states United States Needkstlck Cut with sharp object Cutaneous AIDS patient Concentrated virus AIDS patient Ii 12 care worker 149 PMebotonikt Unt tedStates UnitedStates Non lnt.ctakIn Mucous-membrane AlD spat lent IIIV.in(ectcd patient 13 Tecbnok)$bt UnhedStates Nonlntadsk ln I IIVinfected patient 14 is 115 Nurse UnitedSistea Italy Needlestlck Mucous membrane AIDS patient IIIV infected patient 16 I? iS Ilutse Navy medic Clinical lab wo rkec Fiance UnttedStates U nltedStat e s Needlestick Needkstlck Cut wIthshaip object AIDS patient AIDS patient AIDS patient AIDS patient 2 AII)S patients Concentrated virus AIDS patient Unknown Unknown Unknown United State. Multiple needle- sticks 24 Technician Meiko Multiple needle. stkk . and mucous membrane 25 lab worker United Stales Netdkitkk. puncture wound • AIDS case ------- TIbis 3. Su. , Of T k Tmp1 cI ih for Fr .i u t Eq i4 mro1 Jo t Mv ory P -.1 prot ve sbou bt Nou Cazejo,,* Natwe of T.k/Aozcd A ab 7 Woio ? Db i..ct ijh b od or ot body O iwveiia1 p --’—”.’ qp y I I. Acthuy p.U 4 weboi Ya No b od b ip w , o m Thk/ydoa Ie No No or to b od U.S. Dtp rt ut of Labor. U.S. D n tof H th H0= Servi . Jo z . 4 wy ww L O ap t oorupa& i t p rwiL to kipttit I B v (HBV) a . .um -’ VW (} V). Wto ogton. DC: US D pan L of Labor, US D .ri eoa of Health s H0= Ser s. 19S7. r U ‘11 ‘ ! Illit’! !IIUJHI [ fl 1’! ‘1 ‘I’k t’lI ti I i!J it 1’ ‘If Ii . . I ’ is a’ I.;ii ti I 11111 i ii ‘ ‘ i r ii I ‘ I i I I t I I . , i i ‘I d I I I II ‘liii I 1 i1 11 ‘4 “ S I II Ii I s r2 ’ I i IS II Iflfl 11 I I U ------- MMW JwslI. i • Vol IIINoR• MMW 3p lUSh 1e,.elOh sdloot Tablet P., .sb Mesha fat Eqs4 .eai Used lo the p,,hcsphsV Heihh Cs,. Sesibi Doelic s AU lo, of .kioblsl Ifs lodu hĽh isuods,, of bsctsdol spo t. Meihoč. 3le . .um t piweots lo.totlesel.g. I Si k .eoe f .čy ho. .. as s,b loOPA lasrste , selo,peoluiised peilod of s .e 5 • 6 II) hoses as seeo, So .o.uladu ,ei$ hoH.ICUO Ifols isetlho lsbsweds.l7 Foe those hoUeoli at dev She . peseli.l.ablo a, o.atscl oiweIp $s, Snot of lbs body. es s .lpeh needhe el )bposabls losoths sq.lp.tas slotissicu the wed to aspect.. thess 5,,e, of I .i Who. h kstsd . ho s.s,. aasayssease sIio be s .hh s hush... lscUhp foe aspe000albi of eeotsbk lo,.h. heHuweots. AIfoe .sof_k . s* l eI I fsu ,eI$hISh ou elI o fhstt1 l ot1P01 Hal oslo. pooeuiSisllo. (SO-IOOC. t0.lostoe)o espouse to 51IPPA ,eShSe,edsle,lesl€kotbsfotlt.P41015lb011 apias,t thu (0- d i sweas .*ulof bp the eweud.d, .u Foe ,eso.bls heusuotentt at deekee thel cosot Into conlsd .IIh se *....L5 (s(.. heyni.ecpe bo nctsnt ha.. etc) lablet m ’r 1 4 histhode toe Equipsesil Used lo the P..L.,kd Uhak cots Sdthi - D .l,o,s Mast b.eleth.osse tfrwo...osuie (wigS. bus sot Mpeobocfevnir.s ai3orrslosb a. bscte,loI spot.. Methnde PM eegbteted hospltsi dlslofectsnii 5 as beI doSs, lot l &,.Ii. l s e1Mt ) Use: Thus 55 1551 see s,c flesl deane,, sad otn be wed to. toolbie hakeepls$oesessov.lof .lNshi .heeSsewsol eblileblood o.iM swfs o*kh hose boos.. used oSmull be tinned and dbbdeded otbi so, clesne, se dbhsfectsnl .gent sblth b Istended foe eosin.....entol see Sash sutton Include floats. .d .eb. _ od...le . . . sasu. sauntellops. etc t licps MF 51tiwus atksesots. ueet.iise lees . ’.. —. —— . sad .051 ls.L hal dee. mal b becte,Nl spoe Methade EPA eqbleud hospbsi dbmS etasul d.euofc .l peu .k51es that hew s d lu, tab. declhlpo..’I.Sy sss le hsed sisSies 51 ,.kld . a, salutloss c o& .blb i ii Inns tOO pp. I, .. .seflsblo chlosho • I IOO dIhillo . of soonosihootchald b le ijcb - . ppeushu*elp b eo, blesek pee plasof sap ores). Use: Faslhoseosl.nthMIOi5ebeOnt t0m5515Mat S. .teltrnscopel. blood puss.. cuffs. splInts. etc • sad hew bees ihhIp eoa l.ndnsled olih blood as bloody body Ibil SwIped s, be peeckaned .1 ebLIc ..ste,W befoes the 5e.s iId ehendsel h applIed I.. dhlslecIIo Sue, Shs sk ,. l.n. Le,eIDbMfedloa IMPORTANT Destoojo Meshode U.. Sote,.edhite Lcael wee holiunansi .sei this be lhosouhlj cksned of ii sIeSk atit ------- APPENDIX G ------- APPENDIX G TRAINING PACKET ------- NEIC Exposure Control Plan: Bloodborne Pathogen Exposures Page 1 APPENDIX G: TRAINING PACKET (SAMPLE) TRAINING RECORD (Note: Fill out separate form for each training session) Date of Training Session: ________________________ Number of Hours of Training: _________________________ Location of Training Session: ____________________________ Level of Training Session: Level I: Brief Overview for All Employees Level II: All Employees at Increased Risk Total Number in Training Session: ________ Trainer: ____________________________ Printed Name: ______________________ Phone: ______________ Signature: _________________________ Date: _______________ Please attach content or summary of training session and names and qualifications of persons conducting the training. (See “Trainer Information Sheet.”) Complete one line below for each person attending the training session. Work Location NAME Job Title Number ------- NEIC Exposure Control Plan: Bloodborne Pathogen Exposures Page 2 Appendix G: Training Packet QUALIFICATION VITAE FORM FOR TRAINERS TRAINER NAME: _______ ADDRESS: _____________ TELEPHONE NUMBER: ____ PRESENT POSITION: ____ PROFESSIONAL EDUCATION: Institution Major Degree Year PROFESSIONAL LICENSURE AND/OR CERTIFICATION: RELEVANT PROFESSIONAL EXPERIENCE OR SPECIAL PREPARATION WHICH QUALIFIES YOU FOR TEACHING THIS COURSE: Signature: Date: ------- NEIC Exposure Control Plan: Bloodborne Pathogen Exposures Page 3 Appendix C: Training Packet SAMPLE TRAINING OUTLINE FOR OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS (BBP) 29 CFR 1910.1030 Level I Training (approximately 30 minutes, or via a memorandum and/or brochure) This training is not required under the Standard but is highly recommended. It briefly highlights the general concepts in the Bloodborne Pathogen Standard for those people who will probably not be occupationally exposed to BBP and includes: 1. Where an employee can find a copy of the regulatory text of this Standard. 2. A brief explanation of the Standard: a. Who is covered under the Standard, b. Definitions of: 1. Blood and body fluids. 2. Bloodborne pathogen. 3. Exposure incident. 4. Occupational exposure. 5. Potentially infectious material. 6. Universal precautions. 3. A brief explanation of the employer’s Exposure Control Plan and means by which the employee can obtain a copy of the written plan. 4. Information on the appropriate actions to take and person(s) to contact in an emergency involving blood or other potentially infectious materials. 5. Information about Hepatitis B and Human Immunodeficiency Virus (HIV). 6. Question and answer period. ------- NEIC Exposure Control Plan: 8loodborne Pathogen Exposures Page 4 Appendix C: Training Packet SAMPLE TRAINING OUTLINE FOR OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS (BBP) 29 CFR 1910.1030 Level II Training (approximately 2 hours) This training highlights the general concepts in the Standard for those people who will probably be exposed to BBP, and includes: 1. Where an individual can find a copy of the regulatory text of this Standard. 2. A general explanation of the epidemiology (incidence, distribution, and control of disease in population) mode of transmission, and symptoms of bloodborne disease. Emphasis will be placed on Hepatitis B (HBV) and Human Immunodeficiency Virus (HIV). 3. A general explanation of: a. Who is covered under the Standard, b. Definitions of: 1. Blood and body fluids. 2. Bloodborne pathogen. 3. Exposure incident. 4. Occupational exposure. 5. Potentially infectious material. 6. Universal precautions. C. Engineering controls d. Work practices e. Personal protective equipment, including types, use, handling, and disposal. 4. A brief explanation of the employer’s Exposure Control Plan and means by which the employee can obtain a copy of the written plan, including methods of recognizing work tasks and other activities that may result in exposure. 5. Information on Hepatitis B Vaccine (HBV), and that the vaccine and vaccination will be offered free of charge. 6. Information on Human linmunodeficiency Virus (HIV), and that the screening will be provided free of charge under certain conditions. 7. Information on the appropriate actions to take, procedures to follow, and person(s) to contact in an emergency or exposure incident involving blood or other potentially infectious materials. 8. Information on the post-exposure evaluation and follow- up. 9. Discussion of record keeping requirements for the agency. 10. An explanation of signs and labels and/or color coding required for biohazardous waste. 11. Question and answer period. ------- APPENDIX H ------- APPENDIX H INFORMTION FOR ORDERING APPROVED SHARPS CONTAINERS ------- APPENDIX H APPROVED SHARPS CONTAINERS Approved sharps containers for disposal of syringes/needles are puncture-r istant and splatter-proof. Perry Point Perry Point is the HRSA Supply Service Center located in Perry Pomt. Maryland 21902. (All federal agencies, including federally funded projects, can use Pen-v Point once an account is established.) The following are approved sharps containers that can be ordered through Perry Point 3.5 qt. (24/case) 6515011885345 7.5 qt. (12/case) 6530011832863 For more information on approved sharps containers, call an FEOH re ional office which will also likely be able to provide advice on local disposal regulations. ------- APPENDIX I ------- APPENDIX I STATE OF CALIFORNIA- HEALTH AND WELFARE AGENCY CALIFORNIA MORBIDITY REPORT DATED SEPTEMBER 4, 1992 ------- ste. W - Hsslih aist Wui ,, As p 7E SO GDvww California Morbidity 2151 AjJka.M. , esleesy 54754.1011 ______ Hac.i (510) 0’O- _ . IWlCon ______ The Dm an of Commie cable Disease Control Řormeily, d bdectious Disease 8r ’) pravicx ly publidied rexnvnendaflcns for preveruing mess in sewage workers (Callf irn a Morbidity, Auguat 24,1964). Que O(is nthue to be received, not only lorthe 4 es discussed tasi e bt 5 ao because newer cericems thoid d’ iara. HIV. and Hepad 1s it should be emphasized that there are NO state Immunization recpiremen maidated I c r sewage workers. Any eioli reqisreinerns that exist a’s made atthe local loyal, by employers or by local health agenoes. A ug t CaUOSHA otholats. sewage workers as not cevered by the •CatOSMA 8ioo orne PaPiogens Standard urdess those workers work dire yin cuw ge fleS w)Ihu M th r, $ c c before those lines jon ier (e.g.. vTuT1apa ) sewerage fnes. It stictid also be th ha ized that there axe no n ior uiddines or formal re mendabons in this area (as enunc zed by the Advisory Committee on Inwrsirizabon Pr cesotthe USPHS) nor is there universal agreement on what fIVTUlIZin9 agents sho d be recommended. Tt s is a dutf it aea. where the very small risk of disease (Irom pooled human sewage) must be b J aganst the very small risk of adverse effects (and St) ol on. Though pubrishea data do not eatst for all at the disease- ieof r imendabons oiniined below, there is Deportment of Health Services consensus on the following re mmendadcns: 1. Freqi,wnt, routine handwashing is the jimoortant sitoauard in preverwng infection by agents prss.nt in sewage. 2. Pveai v. clothing (Li., work clothes, covereUs, boots. gloves.-. nf _ re ep,rupriu . and plastie face shields—where appropn.ete) is rsc.unuundd , and such work clothes shOufd b. worn home or outsIde the Innii.dlase work environment. 3. Im.mnexaiian recomm.nd. ons can be cstegur .d as follows: a. Su’srietv Ricuuunendsd 1. T. -diphtherfe (rd)_Ml adu s. aid eupeaally sewage workers. shia.Ad be up -to-dale on Td inTmJr on. For those who havecornpleted the bawc sines of vee litvntsi ations, a booster shotddbegrven every sin years. 2. Noceiur vw1iursz ns as strongly recanuiiendedatthe present tine, but Hepatitis A vecone. recendy sised in Europe (by SnethX ne Beetham). may become licensed and available in the -. Urited S tes 1 ’ dn ’ w I ext severaz y rs. The need fci sewagu waters to receive 0 s v ie will be revIewed at that brrio b. Ootaon 1. Poliomyeftths - This ts a complex iseue. Sewage workers are probably at some risk of exposure to v.cthte polio wus but very raWyb wild polio virus. ki coreiv es with aibeensat twters of recent irrvmwants fran’ Southeast Asia, the nsli of wild virus exposure from pooled sewage may be somewhat greater. no cases of orx Jpesonally ared po omyeUlis have been repoiled in United States sewage workeism the va ne era. Further. unmuru tion with oral (San) poäo vaccine is riot rai nely recommended (or Uriied S es ilts (age 18 and over) of the smaU risk (perhaps one in a nilion) of developing paralytic polio altar meca ng oral po’o ne . This risk is for those who have received no prior doses at polio va ne of any t Wa: the risk extends to urinvasezad household of these va iees. as weL September 4, 1902 Deeanmaie at Nth si . vwam Moliy . sl Coys, M.D . .PJI., Dr r eves doses. c) Pa suns who have never received any Oral polio v me or inactivated polio vacome should receive Inactivateti polio yawns (IPV), exolusively. The m ary sense consIsts of two doses 4-8 weeks ai and a thud dose 6-12 nionthe after the second . The need arid interval for booster doses of IPV li have not been e ialted. Probably, at least one booster dose be taken five years after completion of the primary wws. 2. Typhud Fever - The risk of this disease for sewage workers In Cailfornie is exceodmgly small. Only one case has ever been reported ma Cafilornia sewage worker arid this was sian Ir vid i who had received at toast one dose of typhoid vacolne rine rrcrths previously. - Typhoid immunization Is no: g.nereny r&.o..m.nded . If iutuzaiion is considered, eIther of two va nes i be used: a) Inlectabi. vaccine: The inactivated v ne is only 70 -80 percent effective. The primary sines is two doses, gwen four weeks apart. Pan at the injection site, fever, and malaise we iemr . One fatal reaction has been recordecf in Ca crri A booster dose is needed at least every three yeas tar coninriued protection. The ineadermal 0.1 co dosage can be used for boosters (but not for the primary sines) and Is assooiatec with fewer edo effects. The uraradermal n,jectlon is best given at ttie mceps or deltoid area, not the vofar aspect at the forearm. b) Oral vaccine: The live bacterial vanone, given ii four ca si.4es on alternate days. is at feast as effective as the inactivated va ne and has tower side effects. The lou’- ule series be repeated every five yeas for continued protection. Nol Recommended 1. Irrvre ns glabubri (IG). also called Gamma Globilin (GG) tar Hepatitis A prophylaxis is not recommended because: a) It is relatively expensIve. painkil. and tnt rare Instances is associated with allergic reactions. b) IG injections must be repeated every 4-6 months for oorrn iued protecaon. 2. HepatitIs 8 Vaccine- While blood and other body fluids (a g.. men uaI discharges. etc.) enter the sewage stream. Hepatitis B virus is present in very dilute concentrations. No cases of Hepatitis B have ever been linked to sewage exposure. Moreover, - 1r H ,uJd B i i i u Ib nL4w0’by the fa1 .d1- iaI r Iw, mere is no risk from sewage by this route Hepatitis B v ne rs now mzwveroally recommended tar all inlaits born in the United S es wid for car n high-risk persons. far example, to protect zigasist sexuet transmission, exposures in health care se ngs. a -id benariüsiori by u ected drugs, etc. 3. io$era - The n k of cholera for sewage workers is extremely remote. Only a few cases of imported cholera are reported eadi yea- lii Caillornia aid titers has been no soixindary trans.mssmon. W ’io of eae onneentratlan in Caltorrea sewage is so d ltze as to probably be no -mnfe aus. (Whereas 1 Q2 St’igella are needed iocausedisease.asmanyasio’to 10’ V. o’iolerae ateneecled) Even If cholera did result. specific treatment is readily av slable Cholera yawns is not recommend.d: it Is only about 50 percent effective. requres booster doses every six months. and frequer y produces porn and redness at the injection site, fever, arid malaise. P mst auon is not routinely recommended for sewage Finafy, a word about POV and the nak of AIDS from sewage. The r nnwts waters. If it a to be considered, we eqgsst thw made above about Hepatitis B. and its extreme d ution in sewage, apçiy to ILLNESS IN SEWAGE WORKERS/RECOMMENDATIONS FOR PREVENTION ------- va ne of aiiy type; the n extends to urinTnLsllzed household s o these va ees. as weL P snmun %n nof rovtlnhly recommended tar sewage wakers. if ii to be amsidered. we suggest th a Persons with a history c4 three or more doses at oral (Sabn) polo v ne at any pńor time do not need additional doses. b) P onswthahss cyci l-2dose loralpov neatany or time i talie ad borial doses of either oral polio va rie or ma ivaied (Salk) polio va ine to br g the litadme totol to produces pain and redness at the inie ion site, fever, and malaise. Rna y, a word ab t HIV and the nsk of AIDS from sewage. The r naiuis made above about H a1lbs B. and its extieme di1 tjon in sewage, apply to HIV weILaxce that the level ci HIV in sewage woi4d be even several ci magnitude less than that at Hepatth5 B. Moreover, Ike Hu athis B. HIV is not ansmitted by the fece -arai route. In summery, the nsk at Hepatitis B tram sewage Is virtually nonexistenr and the rIsit of I V transmission tram sewage is even less. ------- |