Regulation Information Bloodborne pathogens §1910.1030; CPL 2-2.44C; STP 2-1.166; CPL 2-2.36 Introduction Bloodborne pathogens are pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, the hepatitis B virus (HBV), the hepatitis C virus (HCV), and the human immunodeficiency virus (HIV). OSHA’s bloodborne pathogens standard, located at §1910.1030, covers an estimated 5.6 million workers in healthcare and other facilities who are at risk of exposure to bloodborne pathogens (BBPs). Exposure to BBPs may occur in many ways. Although needlestick injuries are the most common means of exposure, pathogens can also be transmitted through body fluids, mucous membranes, and non–intact skin. The majority of at-risk workers are in the healthcare field, but exposures can also occur to workers in general industrial and office settings. It’s up to every employer to ensure that those employees are protected. If you have at least one employee with one or more of these responsibilities, OSHA requires your company to develop a bloodborne pathogens exposure control program. OSHA recognizes the need for a regulation that prescribes safeguards to protect workers against the health hazards from exposure to blood and certain body fluids containing bloodborne pathogens, and to reduce their risk to this exposure. OSHA's regulation on bloodborne pathogens was originally published on December 6, 1991. Needlestick safety amendments In November 2000, both houses of Congress approved the Needlestick Safety and Prevention Act of 2000. The act was signed into law and gave OSHA a mandate to revise the Bloodborne Pathogens standard to include requirements for safe medical devices to eliminate or minimize occupational exposure to bloodborne pathogens through needlestick and other sharps injuries. OSHA issued a final rule the following January, which went into effect on April 18, 2001. The revisions to the BBP standard can be broadly categorized into four areas: Modification of definitions relating to engineering controls; Revision and updating of the Exposure Control Plan; Solicitation of employee input; and Recordkeeping. Blood and other potentially infectious materials are recognized as a potential threat to the health of employees who are exposed to these materials by skin penetration. Injuries from contaminated needles and other sharps have been associated with an increased risk of disease from more than 20 infectious agents. The primary agents of concern in current occupational settings are the human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). The Centers for Disease Control and Prevention has estimated that healthcare workers in hospital settings sustain 384,325 injuries involving contaminated sharps annually. When non-hospital healthcare workers are included, the best estimate of the number of these injuries involving contaminated sharps is 590,164 per year. When these injuries involve exposure to infectious agents, the affected workers are at risk of contracting disease. Workers may also suffer from adverse side effects of drugs used for post-exposure prophylaxis and from psychological stress due to the threat of infection following an exposure incident. Revisions to definitions Sharps with engineered sharps injury protections will encompass a broad array of devices that make injury involving a contaminated sharp less likely, and includes, but is not limited to, syringes with a sliding sheath that shields the attached needle after use; needles that retract into a syringe after use; shielded or retracting catheters used to access the bloodstream for intravenous administration of medication or fluids; and intravenous medication delivery systems that administer medication or fluids through a catheter port or connector site using a needle that is housed in a protective covering. Needleless systems which is defined as “devices that do not use needles for: (A) the collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access is established; (B) the administration of medication or fluids; or (C) any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps.” Needleless systems provide an alternative to needles for the specified procedures, reducing the risk of skin penetration injury involving contaminated sharps. Examples of needleless systems include intravenous medication delivery systems that administer medication or fluids through a catheter port or connector site using a blunt cannula or other non-needle connection, and jet injection systems that deliver subcutaneous or intramuscular injections of liquid medication through the skin without use of a needle. Engineering controls has been modified to include as examples safer medical devices, such as sharps with engineered sharps injury protections and needleless systems. This change clarifies that safer medical devices are considered to be engineering controls under the standard. The term includes all control measures that isolate or remove a hazard from the workplace, encompassing not only sharps with engineered sharps injury protections and needleless systems but also other medical devices designed to reduce the risk of percutaneous exposure to bloodborne pathogens. Examples include blunt suture needles and plastic or mylar-wrapped glass capillary tubes, as well as controls that are not medical devices, such as sharps disposal containers and biosafety cabinets. Other revisions include: The exposure control plan must reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens and to document the consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure. This information must be updated at least annually. The employer must solicit input from non-managerial employees in the identification, evaluation, and selection of controls. This must be documented in the exposure control plan. Recordkeeping requirements Recordkeeping requirements are amended to require that employers maintain a sharps injury log to serve as a tool for identifying high risk areas and evaluating devices. The information in the log must protect the confidentiality of the injured employee. At minimum, the sharps injury log must contain the type and brand of device involved in the incident, department where the exposure incident occurred, and an explanation of how the incident occurred. The sharps injury log must be maintained for the period required by 29 CFR 1904. The requirement to establish and maintain the log only applies to employers who are required to maintain a log of occupational injuries and illnesses under 29 CFR 1904, OSHA's Recordkeeping rule. The log may be on paper or electronic. Sharps recordkeeping and OSHA's revised recordkeeping rule Under the revisions to OSHA's recordkeeping rule, employers are required to record sharps injuries involving contaminated objects on the OSHA 300 Log of Work-Related Injuries and Illnesses and the OSHA 301 Injury and Illness Incident Report (these new forms replace the current 200 and 101 forms). When the revised rule becomes effective on January 1, 2002, employers may elect to use the OSHA 300 and 301 forms to meet the sharps injury log requirements, provided two conditions are met. First, the employer must enter the type and brand of the device on either the 300 or 301 form. Second, the employer must maintain the records in a way that segregates sharps injuries from other types of work-related injuries and illnesses, or allows sharps injuries to be easily separated. For example, if OSHA 300 and 301 records are maintained on a computer, the employer must ensure that the computer is able to produce a record of sharps injuries that does not include other types of work-related injuries and illnesses (i.e., through using a program that allows for sorting of entries by injury type). If records are kept on paper forms, the employer would need to use a separate page of the 300 Log for sharps injuries. These revisions to the recordkeeping rule will not become effective until January 1, 2002, and until then many sharps injuries involving contaminated objects will not be recordable on the OSHA log. Therefore, employers must keep a separate sharps log until the revised recordkeeping rule becomes effective. Provisions of the Bloodborne Pathogens standard The following sections provide an overview of the information contained in the standard. For more specific information about how to comply with the standard, click on the regulatory links. Coverage §1910.1030(a) The standard applies to every employer with one or more employees who can reasonably be expected to come into contact with blood and other specified body fluids in carrying out or in performing their duties. Occupational exposure means a “reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of the employee’s duties.” Exposure control plan §1910.1030(c) A written exposure control plan is necessary for the safety and health of workers. Employers must develop a plan that identifies and documents the tasks, procedures, and job classifications covering instances where there is exposure to blood or other potentially infectious materials. Communicating hazards to employees §1910.1030(g) All persons with a potential for exposure must be provided with adequate training and information including general explanations of the modes of transmission, symptoms, epidemiology, and warning signals relating to possible exposure, and procedures to follow if exposure occurs. Preventive measures Hepatitis B Vaccination §1910.1030(f) Employers must make available, free of charge and at a reasonable time and place, the hepatitis B vaccine and vaccination series to all employees who are at risk of occupational exposure. The employee cannot be required to participate in an antibody prescreening program to receive the hepatitis B vaccination series. Vaccinations also must be provided even if the employee initially declines but later accepts treatment while covered by the standard. Employees who decline the vaccination must sign the declination form (found in the standard). Universal precautions Universal precautions is a method of infection control in which all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens. Universal precautions are to be observed in all situations where there is a potential for contact with blood or other potentially infectious material. Under circumstances in which differentiation between body fluid types is difficult or impossible, all body fluids are to be considered potentially infectious. Methods of control §1910.1030(d) Engineering and Work Practice Controls §1910.1030(d)(2) Engineering and work practice controls are the primary methods used to control the transmission of HBV and HIV. To the extent feasible, the employer must institute these controls to eliminate or minimize employee exposure to bloodborne diseases. Personal Protective Equipment §1910.1030(d)(3) In addition to instituting engineering and work practice controls, the standard requires that appropriate personal protective equipment also be used to reduce work risk of exposure. Personal protective equipment is specialized clothing or equipment worn by employees for protection from exposure to blood or other potentially infectious materials. Employers must make readily available, at no cost to employees, appropriate personal protective equipment in the appropriate sizes to provide protection from blood or other potentially infectious materials. Housekeeping §1910.1030(d)(4) Employers must ensure that emergency response vehicles and work sites are maintained in a clean and sanitary condition. Employers shall determine and implement an appropriate written schedule for cleaning and methods of decontamination based upon the location within the facility, type of surface, types of contamination, if any, and tasks or procedures being performed. Labeling §1910.1030(g)(1)(i) Containers of regulated waste, refrigerators and freezers containing blood and other potentially infectious materials, and other containers used to store, transport, or ship blood or other potentially infectious materials must be labeled with fluorescent orange or orange–red biohazard warning labels. What to do if an exposure incident occurs §1910.1030(f) An exposure incident is specific eye, mouth, other mucous membrane, non-contact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties. An example of an exposure incident would be a puncture from a contaminated sharp. Employees should immediately report exposure incidents. This allows for timely medical evaluation and follow-up by a health care professional as well as for timely testing of the source individual's blood for HIV and HBV. Employers must treat reports in the strictest confidence. Recordkeeping §1910.1030(h) There are two types of employee-related records required by the bloodborne pathogens standard: medical and training. Medical records A confidential medical record for each employee with potential for exposure must be preserved and maintained by employers according to OSHA's rule governing access to employee exposure and medical records, Title 29 CFR, Part 1910.1020(e). Training records The bloodborne pathogens standard also requires employers to maintain and keep accurate training records for three years. Declination Statement Appendix A to §1910.1030 Any employee who chooses not to accept the vaccine must sign the statement of declination of hepatitis B vaccination. The statement can only be signed by the employee following appropriate training regarding hepatitis B, hepatitis B vaccination, the efficacy, safety, method of administration, benefits of vaccination, the availability of the vaccine and that the vaccination is free of charge to the employee. The statement is not a waiver; employees can request and receive the hepatitis B vaccination at a later date if they remain occupationally at risk for hepatitis B. Copyright © 2008 J. J. Keller & Associates, Inc. All rights reserved.