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Bloodborne Pathogens means pathogenic microorganisms that may be present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). This article will address HBV exclusively.

Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the commonest chronic infectious diseases worldwide.

The Hepatitis B vaccine is administered intramuscularly in three doses usually given on a schedule of 0, 1, and 6 months, but there can be flexibility in this schedule. More than 95 percent of children and adolescents and more than 90 percent of young, healthy adults develop adequate immunity following the recommended three doses. Persons who respond to the vaccine are protected from both acute hepatitis B infections as well as chronic infection.

OSHA mandates employers make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure, and post-exposure evaluation and follow-up to all employees who have had an exposure incident. OSHA further requires employers are to ensure that all medical evaluations and procedures including the hepatitis B vaccine and vaccination series and post-exposure evaluation and follow-up, including prophylaxis are:

• Made available at no cost to the employee
• Made available to the employee at a reasonable time and place
• Performed by or under the supervision of a licensed physician or by or under the supervision of another licensed healthcare professional

Following a report of an exposure incident, OSHA mandates that the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow-up, including at least the following elements:

1.  Documentation of the route(s) of exposure
2. The circumstances under which the exposure incident occurred
3. Identification and documentation of the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law

Hepatitis B Post-Vaccination Titer Notes:

• All healthcare workers should have serologic testing 1–2 months following the final dose of the hepatitis B vaccine series.
• If adequate anti-HBs is present (>10mIU/mL), nothing more needs to be done.  An anti-HBs serologic test result of >10mIU/mL indicates immunity.  Periodic testing or boosting is not needed. If the post-vaccination test result is less than 10mIU/mL, the vaccine series should be repeated and testing done 1–2 months after the second series.

Hepatitis B Vaccine Notes:

•  Brand Names: Engerix-B, Recombivax HB
• The hepatitis B vaccine has been available since 1982.
• The hepatitis B vaccine causes the body to produce protective levels of hepatitis B antibodies which will protect against infection from hepatitis B virus.
• The Advisory Committee on Immunization Practices (ACIP) recommends hepatitis B      vaccination for everyone 18 years of age and younger, and for adults over 18 years of age who are at risk for HBV infection.
• There is no known cure for hepatitis B. Thus, prevention is the best option to dealing with this disease.  Currently, the only Food and Drug Administration (FDA) approved medicines for treatment of hepatitis B are Interferon Alpha and Lamivudine.
  • Interferon Alpha is usually used only for persons whose liver enzyme tests are abnormal.
  • The FDA recently approved Lamivudine in December 1998 for the treatment of chronic hepatitis.

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Bloodborne Pathogens means pathogenic microorganisms that may be present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV).

Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the commonest chronic infectious diseases worldwide.

Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) Hepatitis C is rarely observed as the early disease is generally quite mild.

HIV, the human immunodeficiency virus, is the virus that causes AIDS, a debilitating and deadly disease of the human immune system.

In the healthcare setting, bloodborne pathogen transmission occurs predominantly by percutaneous or mucosal exposure ofworkers to the blood or body fluids of infected patients. Occupationalexposures that may result in HIV, HBV, or HCV transmission include needlestick and other sharps injuries; direct inoculation of virusinto cutaneous scratches, skin lesions, abrasions, or burns; andinoculation of virus onto mucosal surfaces of the eyes, nose,or mouth through accidental splashes. NOTE: HIV, HBV, and HCV do notspontaneously penetrate intact skin, and airborne transmissionof these viruses does notoccur.

OSHA mandates the Hepatitis B vaccination shall be made available after the employee has received training on the hepatitis B vaccine 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.

If the employee initially declines the hepatitis B vaccination but at a later date while still covered under the standard decides to accept the vaccination, the employer shall make available the hepatitis B vaccination at that time. The employer shall assure that employees who decline to accept hepatitis B vaccination offered by the employer sign a mandatory Hepatitis B Vaccine Declination Form.

To avoid exposures to bloodborne pathogens, OSHA states : when there is occupational exposure, 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 employee’s work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.

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Tuberculosis (TB) – An infectious bacterial disease transmitted through the air that mainly affects the lungs.  With rare exceptions, TB is infectious only when it occurs in the lungs or larynx. TB that occurs elsewhere in the body is usually not infectious, unless the person also has TB in the lungs or larynx at the same time.

According to the Centers for Disease Control and Prevention (CDC), an estimated 2 billion persons (i.e., one third of the world’s population) are infected with M. tuberculosis. Tuberculosis kills almost 1.6 million people per year. Although the 2007 TB rate (4.4 cases per 100,000 population) was the lowest recorded in the United States since national reporting began in 1953, the average annual decline has slowed since 2000. TB is now the second most common cause of death from infectious disease in the world after human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS).

Characteristics of persons exposed to M. tuberculosis that might affect the risk for infection are not well defined. The probability that a person who is exposed to M. tuberculosis will become infected depends primarily on the concentration of infectious droplet nuclei in the air and the duration of exposure to a person with infectious TB disease. The closer the proximity and the longer the duration of exposure, the higher the risk is for being infected. Additional hazards are now present because of multidrug-resistant (MDR) TB. MDR organisms are resistant to the drugs that are normally used to treat TB, such as Isoniazid and Rifampin. The course of treatment when treating MDR TB increases from 6 months to 18-24 months, and the cure rate decreases from nearly 100% to less than 60%. Mortality among patients with MDR-TB can be high.

TB disease in persons over the age of 65 constitutes a large proportion of TB cases in the United States. Many of these individuals have latent TB infection; however, with aging these individuals’ immune function starts to decline, placing them at increased risk of developing active TB disease, and employees in long-term care facilities at risk of occupational exposure to TB. Nursing homes or long-term care facilities for the elderly have been identified as having a high-risk situation for the transmission of TB. The degree of risk of occupational exposure of a worker to TB will vary based on a number of factors.

OSHA withdrew its 1997 proposed standard on Occupational Exposure to Tuberculosis because it is unlikely to result in a meaningful reduction of disease transmission caused by contact with the most significant remaining source of occupational risk: exposure to individuals with undiagnosed and unsuspected TB.

Although OSHA has no standard for TB Infection Control, it will enforce the “General Duty Clause” in situations where employers’ failure to implement available precautions exposes workers to the hazard of TB infection. Created under the Occupational Safety & Health Act of 1970, the General Duty Clause can be thought as an employer’s general responsibility to ensure the safety of all its employees and states: “Each employer shall furnish to each employee a place of employment which is free from recognized hazards that cause or are likely to cause death or serious physical harm & each employee shall comply with the occupational safety & health standards and all rules, regulations and orders issued pursuant to this Act which are applicable to his own actions and conduct.” Additionally, OSHA requires employers with employee exposure to TB must comply with certain requirements including: 1910.134 – Respiratory Protection, 1910.145 – Accident Prevention Signs and Tags, and 1904 – Recordkeeping.

Under the General Duty Clause, OSHA will issue citations to employers with employees working in one of the workplaces where the CDC has identified workers as having a higher incidence of TB infection than the general population, when the employees are not provided appropriate protection and who have exposure as defined below:

• Exposure to the exhaled air of an individual with suspected or confirmed pulmonary TB disease
Or
• Employee exposure without appropriate protection to a high hazard procedure performed on an individual with suspected or confirmed infectious TB disease and which has the potential to generate infectious airborne droplet nuclei.

Furthermore: OSHA will issue citations under the “General Duty Clause” in cases where the following procedures are not followed:

• Periodic Evaluations: TB skin testing shall be conducted every three (3) months for workers in high risk categories, every six (6) months for workers in intermediate risk categories, and annually for low risk personnel. The CDC has defined the criteria for high, intermediate, and low risk categories.

When working with TB potential hazards, OSHA recommends the prompt implementation of early screening procedures, and staff training to help them identify potentially infectious individuals, which will allow for early identification of patients with infectious TB and the initiations of appropriate controls before occupational exposure occurs to staff and other patients.

OSHA encourages employers to follow the guidelines established by the Centers for Disease Control and Prevention (CDC), Division of Tuberculosis Elimination (DTBE) to minimize the potential of TB transmission.

Should TB exposure occur, OSHA Directive CPL 2.106 states individuals with suspected or confirmed infectious TB disease must be placed in a respiratory acid-fast bacilli (AFB) isolation room. High hazard procedures on individuals with suspected or confirmed infectious TB disease must be performed in AFB treatment rooms, AFB isolation rooms, booths, and/or hoods. (AFB isolation refers to a negative pressure room or an area that exhausts room air directly outside or through HEPA filters if recirculation is unavoidable).

OSHA requires all healthcare settings establish a TB infection control program designed to ensure prompt detection, airborne precautions, and treatment of persons who have suspected or confirmed TB disease.

Fundamentals of Effective TB Infection Control:

Administrative Controls
Environmental Controls
Respiratory-Protection Controls

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A brief overview of OSHA’s Needlestick Safety and Prevention Act of 2001:

Needlestick injuries and other sharps-related injuries which expose workers to bloodborne pathogens continue to be an important public health concern. In 1991, OSHA issued the Bloodborne Pathogens Standard.  The Occupational Safety and Health Administration published the Occupational Exposure to Bloodborne Pathogens standard in 1991 because of a significant health risk associated with exposure to viruses and other microorganisms that cause bloodborne diseases. Of primary concern are the human immunodeficiency virus (HIV) and the hepatitis B and hepatitis C viruses.  This standard safeguards employees from occupational exposure to blood or other potentially infectious materials.  OSHA delineates concise measures employers must implement to reduce/eliminate potential bloodborne hazards.  OSHA mandates each employer with employees subject to occupational exposure to bloodborne pathogens must establish a written Exposure Control Plan designed to eliminate or minimize employee exposure.  The Exposure Control Plan shall be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with occupational exposure.

Congress passed the Needlestick Safety and Prevention Act directing OSHA to revise the bloodborne pathogens standard to establish in greater detail, requirements that compel employers to identify and make use of effective and safer medical devices. That revision was published on Jan. 18, 2001, and became effective April 18, 2001.

The revision to OSHA’s bloodborne pathogens standard added new requirements including additions to the exposure control plan and keeping a sharps injury log.  The revision specifies in greater detail the engineering controls, such as safer medical devices, which must be used to reduce or eliminate worker exposure.  Furthermore, OSHA requires the employer’s Exposure Control Plan, including an annual review and update to reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens. The employer must: take into account innovations in medical procedure and technological developments that reduce the risk of exposure (e.g., newly available medical devices designed to reduce needlesticks); and document consideration and use of appropriate, commercially-available, and effective safer devices (e.g., describe the devices identified as candidates for use, the method(s) used to evaluate those devices, and justification for the eventual selection).

A vital component of the Needlestick Safety and Prevention Act of 2001 requires each employer who is required to establish an Exposure Control Plan to solicit input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps in the identification, evaluation, and selection of effective engineering and work practice controls and shall document the solicitation in the Exposure Control Plan.

The 2001 revisions to the bloodborne pathogens standard clearly states that each employer shall establish and maintain a sharps injury log for the recording of percutaneous injuries from contaminated sharps. The information in the sharps injury log shall be recorded and maintained in such manner as to protect the confidentiality of the injured employee. The sharps injury log shall contain, at a minimum:

+  The type and brand of device involved in the incident

+  The department or work area where the exposure incident occurred

+  An explanation of how the incident occurred

Most likely, OSHA will continue to monitor leading medical surveillance systems and adopt further controls to reduce or eliminate occupational exposure to bloodborne pathogens in healthcare environments.

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Most healthcare employers are aware that OSHA mandates bloodborne pathogens training to all employees who are subject to bloodborne pathogens in the workplace.  OSHA’s Regulation, in part, specifically states: “The employer shall train each employee with occupational exposure in accordance with the requirements of this section.  Such training must be provided at no cost to the employee and during working hours.  The employer shall institute a training program and ensure employee participation in the program.  Training shall be provided as follows:

• At the time of initial assignment to tasks where occupational exposure may take place &
• At least annually thereafter”

Although most healthcare employers are aware of their responsibility to comply with this federal law, many employers fail to recognize the real value of instituting a comprehensive bloodborne pathogens training program – creating a safer work environment for all employees at their facility subject to bloodborne pathogen exposures.

OSHA passed the Occupational and Safety Act in 1970 for several reasons: the most important being to assure safe and healthful working conditions for working men and women.  Even though healthcare employers are compelled to comply with this federal law, they should consider the following benefits to their practice regardless of OSHA’s initiatives:

• Increased productivity
• Increased income
• Increased efficiencies
• Employee retention
• Reduction in recruiting costs
• Reduction in costs associated with new employee orientation
• Reduction in workers’ compensation premiums

On the other hand, healthcare employers need to recognize the avoidable costs associated with the lack of a well constructed OSHA bloodborne pathogens training program.  Did you know the average cost assigned to sharps injuries is $3,042 (O’Malley, Scott, Gayle, Dekutoski, Foltzer, Lundstrom, et al., 2007)?  This includes the source patient and employee and is directly attributed to the following factors:

• Baseline and Follow-Up Laboratory Testing
• Labor Costs Associated with Testing & Counseling
• Cost of Post-Exposure Prophylaxis

The cost associated with the sharps injuries statistic noted above does not take into account:

• Lost time from work/lower productivity
• Loss of income
• Loss of career
• Emotional costs
• Societal costs
• Long-term costs

Healthcare employers need to independently recognize the true value of installing safer healthcare practices at their facility regardless of federal mandates and intervention.  The best means to accomplish this is through the educational process – empower your employees with work practice controls and universal precautions.  It’s a win/win situation – employers and employees benefit alike.

OSHA Optics, LLC

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EMail: Compliance@OSHAOptics.com