Bloodborne Pathogens and Infection Control OSHA

Objectives:

Upon completion of this course the student will have an understanding of the proper handling of hazrdous bio-waste they may encounter in their duties as a healthcare worker, the infectious diseases associated with these bloodborne pathogens, the steps needed to prevent these infections and the OSHA regulations and rules regarding them.

Exposure to blood or other potentially infectious materials (OPIM) is an issue of growing concern for health care workers. Care must be taken to prevent the transmission of bloodborne pathogens such as the Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV), in the workplace.

The following topics relate to occupational safety and health hazards with blood or OPIM:

· Bloodborne Pathogens Standard	· Personal Protective Equipment
· Needlestick Injuries	· Latex Allergy
· Other Sharps	· Labeling and Signs
· Universal Precautions	· HBV, HIV, and HCV

Bloodborne Pathogens Standard

Definitions for bloodborne pathogens, other potentially infectious materials (OPIM), and occupational exposure are found in 1910.1030(b).

Hazard

Example Controls

Provide an effective ECP and training as required by the Bloodborne Pathogens Standard [1910.1030]. Each employer must:

Identify employees who have occupational exposure to blood or OPIM [1910.1030(b)], and then establish and implement a written Exposure Control Plan (ECP), designed to eliminate or minimize employee exposure [1910.1030(c)(1)].
The ECP must be made available to all employees [1910.1030(c)(1)(iii)] and be reviewed and updated at least yearly [1910.1030(c)(1)(iv)].
Ensure that employees with occupational exposure to bloodborne pathogens receive appropriate training at no cost to employees, and during working hours [1910.1030(g)(2)(i)].

Training requirements are listed in [1910.1030(g)(2)(vii)].

It is recommended that employers review record keeping data required by the bloodborne pathogens standard to help evaluate the effectiveness of the ECP.

Example Exposure Control Plans:

A Model Exposure Control Plan is provided to assist employers in developing their own plans [OSHA Directive CPL 2-2.44D Appendix D (1999, November 5)]. The following sections and downloadable forms are provided below.
Exposure Control Plan

Policy
Program Administration
Employee Exposure Determination
Methods of Implementation and Control
Hepatitis B Vaccine
Post-exposure Evaluation and Follow-up

Administration of Post-Exposure Evaluation and Follow-Up
Procedures for Evaluating the Circumstances Surrounding an Exposure Incident

Employee Training
Record keeping

Sample Forms:

Written Opinion for Hepatitis B Vaccination
Written Opinion for Post-Exposure Evaluation
Bloodborne Pathogen Exposure Evaluation Form
Hepatitis B Declination Form

Additional Information:

Bloodborne Pathogens Technical Links Page.
Model Exposure Control Plan for Home Care: A Guide for Hospice/Home Agencies on the Bloodborne Pathogens Standards. OSHA Office of Occupational Nursing, (1994), 5.2K PDF, 74 pages.

Needlestick Injuries

An estimated 800,000 needlestick injuries occur each year. Nursing staff are most frequently injured. EPINET Data show needlestick injuries occur most frequently in patient rooms.
Needlestick injuries account for up to 80 percent of accidental exposures to blood. (OSHA JSHQ, 1998).
NOTE: Recording of Exposure Incidents: For recordkeeping purposes, an occupational bloodborne pathogens exposure incident (e.g. needlestick, laceration, or splash) should be classified as an injury since it is usually the result of an instantaneous event or exposure. CPL 2-2.44D,X.

Hazard

Exposure to blood and OPIM from needlestick injuries due to:

Unsafe needle devices.

Improper handling and disposal of needles.

Example Controls

Engineering and Work Practice Controls must be the primary means to eliminate or minimize exposure to bloodborne pathogens. Where engineering controls will reduce employee exposure either by removing, eliminating or isolating the hazard, they must be used, and changes to the Exposure Control Plan (ECP) must include these engineering controls [1910.1030(c)(1)(iv), 1910.1030(d)(2)(i) and OSHA Directive 2.44D, XIII (D)(2)].

Engineering Controls are controls (e.g., sharps disposal containers, self-sheathing needles) that isolate or remove the bloodborne pathogens hazard from the workplace [1910.1030(b)].

NOTE: The exposure control plan must document consideration and implementation of appropriate commercially available and effective engineering controls designed to eliminate or minimize exposure [OSHA Directive 2.44D,XIII,C5].

Work Practice Controls are controls that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique) [1910.1030(b)].
Needlestick prevention program: The standard requires immediate follow-up of employees after a needlestick [1910.1030(f)(3)]. It is recommended that such follow-up include identifying injury patterns and accident analysis to determine if other training, procedures, or safer needle devices should be used to prevent future accidents.

Post-exposure Evaluation and Follow-up also includes:

A confidential medical exam [1910.1030(f)(3)].
Documentation of the route(s) of exposure, and the circumstances under which the exposure incident occurred [1910.1030(f)(3)(i)].
Testing of the source individual's blood [1910.1030(f)(3)(ii)(A)] and making the results of the source individual's testing usually after consent available to the exposed employee [1910.1030(f)(3)(ii)(C)].

Administration of post-exposure prophylaxis, when medically indicated, as recommended by the U.S. Public Health Service [1910.1030(f)(3)(iv)].

Unsafe Needle Devices: Most needlestick injuries result from unsafe needle devices, rather than carelessness by health care workers.

Safer needle devices have built-in safety control devices, such as those that use a self-sheathing needle, to help prevent injuries before, during, and after use through safer design features.

The FDA is responsible for clearing medical devices for marketing in the U.S. It recommends safer needle devices with a fixed safety feature that:

Provides a barrier between the hands and the needle after use; the safety feature should allow or require the worker's hands to remain behind the needle at all times.
Is an integral part of the device and not an accessory.
Is in effect before disassembly and remains in effect after disposal to protect users and trash handlers, and for environmental safety.
Is as simple as possible, and requires little or no training to use effectively.

Improper Handling and Disposal of Needles/Sharps:
Proper handling and disposal of needles can reduce needlestick injuries. For example, the Bloodborne Pathogens Standard:

Prohibits the recapping, bending, or removal of contaminated sharps, to avoid accidental punctures. Shearing or breaking of contaminated needles is also prohibited [1910.1030(d)(2)(vii)].

Unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure. In such cases the recapping or needle removal must be accomplished through the use of a mechanical device or one handed technique (2)(vii)(A) and (d)(2)(vii)(B).

Requires discarding of contaminated needles and other sharp instruments immediately or as soon as feasible after use into appropriate containers [1910.1030(d)(4)(iii)(A)(1)].

Containerization

Appropriate containers must be [1910.1030(d)(4)(iii)(A)(1)]:

Closable, puncture-resistant and leak-proof on sides and bottom.
Accessible, maintained upright and not allowed to overfill.
Labeled or color coded according to 1910.1030(g)(1)(i)

Colored red or labeled with the biohazard symbol.
The label shall be fluorescent orange or orange-red, with lettering and symbols in a contrasting color [1910.1030(g)(1)(i)(C)].
Red bags or containers may be substituted for labels [1910.1030(g)(1)(i)(E)].

Other Sharps
"Contaminated Sharps" means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires [1910.1030(b)].

Hazard

Exposure to blood and OPIM through other sharps:

Glass Capillary Tubes that break when used may result in a penetrating wound and expose workers to blood and OPIM.

I.V. Connectors that use needle systems increase the risk of exposure to bloodborne pathogens through needlestick injuries.

Disposable razors that could be contaminated with blood should be considered "contaminated sharps" and disposed of properly in appropriate sharps containers.

Example Controls

Implement engineering and work practice controls to help prevent exposures.

Capillary Tubes:

Broken glassware, such as capillary tubes is not to be picked up directly with the hands [1910.1030(d)(4)(ii)(D)].
Regulated wastes including capillary tubes need to be disposed of properly [1910.1030(d)(4)(iii)].
Gloves must be worn when among other things, handling or touching contaminated items or surfaces, such as capillary tubes [1910.1030(d)(3)(ix)].
In their joint document (Glass Capillary Tubes: Joint Safety Advisory About Potential Risks (1999, February)), OSHA, FDA and NIOSH warn health care workers about the hazards from breakage of glass capillary tubes and recommend the use of:

Capillary tubes that are not made of glass.
Glass capillary tubes wrapped in puncture-resistant film.
Products that use a method of sealing that does not require manually pushing one end of the tube into putty to form a plug.

I.V. connector systems: The use of needleless connector systems with I.V. setups is an engineering control that will minimize occupational exposure.

FDA urges the use of needleless systems or recessed needle systems to reduce the risk of needlestick injuries and exposure to bloodborne pathogens.

These connectors use devices other than needles to connect one I.V. to another. This example shows the plunger-type system.

Universal Precautions
An approach to infection control which treats all human blood and other potentially infectious materials as if they were infectious for HIV and HBV or other bloodborne pathogens [1910.1030(b)].

Hazard

Exposure to bloodborne pathogens because employees are not using Universal Precautions.

Example Controls

Implement Universal Precautions according to the Bloodborne Pathogens Standard [1910.1030(d)(1)].

Treat all blood and other potentially infectious materials with appropriate precautions such as:

Use gloves, masks, and gowns if blood or OPIM exposure is anticipated.
Use engineering and work practice controls to limit exposure.

There are other concepts in infection control that are acceptable alternatives to universal precautions, such as Body Substance Isolation (BSI) and Standard Precautions (OSHA CPL 2-2.44D, Section D):

These methods define all body fluids and substances as infectious and incorporate not only the fluid and materials covered by the Bloodborne Pathogens Standard, but expand coverage to include all body fluids and substances.

Personal Protective Equipment (PPE)

Hazard

Exposure to blood and OPIM due to an ineffective PPE program. Common problems include improper:

Use of PPE

Handwashing

Disposal of PPE

Example Controls

Personal Protective Equipment (PPE) is required by the Bloodborne Pathogens Standard and can provide some protection from infectious materials as a barrier to protect skin and mucous membranes from contact with blood and other potentially infectious materials.

Appropriate PPE, addressed in 1910.1030(d)(3)(i), must be provided by the employer, at no cost to the employee, in appropriate sizes and be used by personnel if blood or OPIM exposure is anticipated. The type and amount of PPE depends on the anticipated exposure. PPE includes:

Gloves, gowns, laboratory coats, masks, face shields, eye protection, mouthpieces, resuscitation bags, pocket masks, or other ventilation devices.
Gloves must be worn when hand contact with blood, mucous membranes, OPIM, or non-intact skin is anticipated, and when performing vascular access procedures, or when handling contaminated items or surfaces [1910.1030(d)(3)(ix)].

Handwashing according to the Bloodborne Pathogen Standard:

Employers must ensure that employees wash hands and any other skin with soap and water or flush mucous membranes with water as soon as feasible after contact with blood or other potentially infectious materials (OPIM) [1910.1030(d)(2)(vi)].
Employers must provide readily accessible handwashing facilities, [1910.1030(d)(2)(iii)] and ensure that employees wash their hands immediately or as soon as feasible after removal of gloves [1910.1030(d)(2)(v)].

Disposal of Protective Clothing:

Protective clothing must be removed before leaving the room; [1910.1030(d)(3)(vii)], and disposed of in an appropriately designated area or container for storage, washing, decontamination or disposal [1910.1030(d)(3)(viii)].

Latex Allergy

It is estimated that 8-12% of health care workers are latex sensitive with reactions ranging from irritant contact dermatitis and allergic contact sensitivity, to immediate, possibly life threatening, sensitivity.

Hazard

Developing latex sensitivity or latex allergy from exposure to latex in products like latex gloves.

Example Controls

Use appropriate gloves for latex-sensitive employees:

The employer shall ensure that appropriate personal protective equipment, in the appropriate sizes, is readily accessible at the worksite or is issued to employees. Hypoallergenic gloves, glove liners, powderless gloves, or other similar alternatives shall be readily accessible to those employees who are allergic to the gloves normally provided [1910.1030(d)(3)(iii)].

Among the alternatives are synthetic, low protein, and powder free gloves. Powder free gloves may reduce systemic allergic responses.

Eliminate the unnecessary use of latex gloves when no risk of exposure to blood or OPIM exists.

Note: Hypoallergenic gloves, glove liners, or powderless gloves are not to be assumed to be non-latex or latex free.
The FDA now requires labeling statements for medical devices that contain natural rubber and prohibits the use of the word "hypoallergenic" to describe such products. (Federal Register, Volume 62, No. 189, effective September 30, 1998). A summary is provided in the FDA talk paper Latex Labeling Required for all Medical Devices (1997, September 30).

Hand washing is required by OSHA's Bloodborne Pathogens Standard after removal of gloves or other personal protective equipment. This helps to minimize powder and/or latex remaining in contact with the skin [1910.1030(d)(2)(v)].

It is recommended that thorough clean-up of any residual powder in the workplace with appropriate vacuum filters will reduce latex sensitivity and decrease employee exposure.

Labeling and Signs

Hazard

Exposure to bloodborne pathogens due to improper labeling and signs of potential hazards.

Individual units of blood, for transfusion

Biohazard label on regulated waste containers

Disposal of contaminated I.V. tubing into a biohazardous waste container

Example Controls

Implement labeling and signs required by the Bloodborne Pathogens Standard, such as:

Biohazardous Waste Container: Regulated waste, such as I.V. tubing used to administer blood, contaminated PPE, and needles etc., must be disposed of into appropriately labeled biohazardous waste containers [1910.1030(g)(1)(i)(A)].

Biohazard Label: Containers that contain regulated waste, (contaminated PPE, needles, etc.), must bear the biohazard symbol, in accordance with 1910.1030(g)(1)(i)(A).

These labels shall be fluorescent orange or orange-red, with lettering and symbols in a contrasting color [1910.1030(g)(1)(i)(C)].

Red bags or red containers may be substituted for labels [1910.1030(g)(1)(i)(E)].

Exception for Blood Products: Individual containers of blood, blood components, or products that are labeled as to their contents and have been released for transfusion or other clinical use need not be labeled as hazardous [1910.1030(g)(1)(i)(F)].
Note: Individual containers of blood or OPIM need not be labeled if placed in a labeled container for storage, transport, shipment or disposal [1910.1030(g)(1)(i)(G)].

Bloodborne Illnesses - Hepatitis B Virus
Hepatitis is an inflammation of the liver that can lead to liver damage and/or death. The CDC estimates 800 health care workers became infected with HBV in 1995. This figure represents a 95% decline in new infections from the 1983 figures. The decline is largely due to the immunization of workers with the Hepatitis B vaccine, and compliance with other provisions of OSHA's Bloodborne Pathogens Standard.

Hazard

Exposure to potentially fatal bloodborne illnesses such as Hepatitis B Virus (HBV).

Hepatitis is much more transmissible than HIV.
Risk of infection from a single needlestick is 6%-30% (CDC 1997).
50% of the people with HBV infection are unaware that they have the virus.
The CDC states that HBV can survive for at least one week in dried blood on environmental surfaces or contaminated needles and instruments.

Example Controls

Prevent the exposure in the first place by implementing an effective Exposure Control Plan as required by the Bloodborne Pathogens Standard [1910.1030(c)(1)].
Employers must offer to all employees who have occupational exposure to blood or OPIM, under the supervision of a licensed physician the hepatitis b vaccination [1910.1030(f)(2)]:

Except as provided in 1910.1030(f)(2)(i).

At no cost to employee, at a reasonable time and place [1910.1030(f)(2)(i)].
After the employee has received the required training [1910.1030(f)(1)].
Within 10 working days of initial assignment.
Those declining the hepatitis b vaccine must sign a declination statement . A sample declination form is available.
OSHA provides the following non-mandatory sample form: Written Opinion for Hepatitis B Vaccination.

Health care workers who have ongoing contact with patients or blood and are at ongoing risk for injuries with sharp instruments or needlesticks must be offered testing for antibody to hepatitis B surface antigen one to two months after the completion of the three-does vaccination series.

Employees who do not respond to the primary vaccination series must be offered a second three dose vaccine series and retesting. Non-responders must be offered medical evaluation [1910.1030(f)(1)(ii)(D)].

Following a report of an exposure incident the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow-up [1910.1030(f)(3)].
If a worker is exposed to HBV, timely post-exposure follow-up with hepatitis b immune globulin and initiation of hepatitis b vaccine which must be offered [1910.1030(f)(1)(ii)(D)], are more than 90% effective in preventing HBV infection.
A health care professional's written opinion is required after an exposure incident [1910.1030(f)(5)].

OSHA provides a non-mandatory sample form

Bloodborne Illnesses - Human Immunodeficiency Virus (HIV)

HIV infection has been reported following occupational exposures to HIV-infected blood through needlesticks or cuts; splashes in the eyes, nose, or mouth; and skin contact. Most often, however, infection occurs from needlestick injury or cuts.

Hazard

Exposure to potentially fatal bloodborne illnesses such as HIV.

Risk of HIV infection after needlestick is 1 in 3000 or 0.3%.
The CDC documented 55 cases and 136 possible cases of occupational HIV transmission to U.S. health care workers between 1985 and 1999.

Example Controls

Prevent the exposure in the first place by implementing an effective Exposure Control Plan as required by the Bloodborne Pathogens Standard [1910.1030(c)(1)].
Under certain circumstances post-exposure prophylaxis for HIV must be provided to health care workers who have an exposure incident, as defined in 1910.1030(b).
- Limited data suggests that such prophylaxis may considerably reduce the chance of becoming infected with HIV. However, the drugs used for prophylaxis have many adverse side effects.
- No vaccine currently exists to prevent HIV infection, and no treatment exists to cure it.
Employees who have an incident must be offered a confidential medical evaluation and follow-up [1910.1030(f)(3)].
- A health care professional's written opinion is required after an exposure incident [1910.1030(f)(5)(ii)].
  - The non-mandatory sample form is available: Written Opinion for Post-Exposure Evaluation.

Bloodborne Illnesses - Hepatitis C Virus (HCV)
HCV infection is the most common chronic bloodborne infection in the United States, affecting approximately 4 million people. Hepatitis C infection is caused most commonly by needlestick injuries. HCV infection often occurs with no symptoms, but chronic infection develops in 75% to 85% of patients, with 70% developing active liver disease (CDC 1998).

Hazard

Exposure to potentially fatal bloodborne illnesses such as Hepatitis C Virus (HCV), which is:

A major cause of chronic liver disease.
The leading reason for liver transplants in the United States in 1997 (CDC).

Example Controls

Prevent the exposure in the first place by implementing an effective Exposure Control Plan as required by the Bloodborne Pathogens Standard [1910.1030(c)(1)].
Employees who have an exposure incident shall be offered a confidential medical evaluation and follow-up [1910.1030(f)(3)].
A health care professional's written opinion is required after an exposure incident [1910.1030(f)(5)].

The following non-mandatory sample form is available: Written Opinion for Post-Exposure Evaluation.

No vaccine is available for hepatitis C. Immunoglobulin or antiviral therapy is not recommended and no effective post-exposure prophylaxis is known at this time (CDC 1998).

CLICK HERE FOR OSHA 1910.1030

Recordkeeping

According to the OSH Act of 1970 "each employer shall make, keep and preserve, and make available to the Secretary or the Secretary of Health, Education, and Welfare, such records regarding his activities relating to this Act as the Secretary, in cooperation with the Secretary of Health, Education, and Welfare, may prescribe by regulation as necessary or appropriate for the enforcement of this Act or for developing information regarding the causes and prevention of occupational accidents and illnesses."

Hazard

Employers not maintaining records which help:

Document trends in illness and injury.

Develop information regarding the causes and prevention of occupational accidents and illnesses.

Example Controls

Comply with OSHA Recordkeeping Standards:

	Recording and Reporting Occupational Injuries and Illnesses [1904].
	OSHA 200 Log: Log and Summary of Occupational Illnesses & Injuries: Log description, who it applies to, and posting requirements. Definition of recordable illnesses and injuries.
	OSHA 101 Log: Supplementary Record of Occupational Injuries & Illnesses.
	OSHA Standard 1910.1020(e) Access to Employee Exposure and Medical Records.

Recordkeeping for Bloodborne Pathogens

Hazard

Non compliance with the Bloodborne Pathogens Standard recordkeeping requirements.

Example Controls

The Bloodborne Pathogens Standard [1910.1030], requires both medical and training records be maintained [1910.1020].
Medical Records must be preserved and maintained for each employee with occupational exposure to bloodborne pathogens [1910.1030(h)(1)].

For at least the duration of employment plus 30 years, and must be kept confidential (not disclosed without written permission of employee, except by law) and separate from other personnel records and must also include:

The employee's name and social security number, hepatitis B vaccination status, including the dates of vaccination and medical records related to the employee's ability to receive vaccinations.

If an exposure incident occurs, reports are added to the medical record to document the incident, including testing results following the incident, follow-up procedures, and the written opinion of the health care professional.

Training Records: Employers must establish and maintain a training record for all exposed employees for 3 years, from the date the training occurred which includes [ 1910.1030(h)(2)]:

The names and job titles of all persons attending the training sessions, the dates, and content of the training sessions, and the trainer's name and qualifications.
If the employer ceases to do business:

Training and medical records must be transferred to the next employer or successor employer.
If there is no successor employer, the employer must notify the Director of the National Institute for Occupational Safety and Health (NIOSH) for specific directions for the records at least 3 months prior to intended disposal.

Both medical and training records must be available to [1910.1030(h)(3)(ii)]:

Director of NIOSH.
Assistant Secretary of Labor for Occupational Safety and Health.
Employees or employee representatives (someone having written consent of the employee).

Additional Information

Bloodborne Pathogens and Acute Care Facilities, Recordkeeping OSHA Publication 3128 (1992).

Exposure Control Plan-Policy

The Model Exposure Control Plan is intended to serve as an employer guide to the OSHA Bloodborne Pathogens standard. A central component of the requirements of the standard is the development of an exposure control plan (EXP).

The intent of this model is to provide small employers with an easy-to-format for developing a written exposure control plan. Each employer will need to adjust or adapt the model for their specific use.

The information contained in this publication is not considered a substitute for the OSH Act or any provision of OSHA standards. It provides general guidance on a particular standard-related topic but for specific compliance requirements.

The (Company Name)__________________ is committed to providing a safe and healthful work environment for our entire staff. In pursuit of this endeavor, the following exposure control plan (ECP) is provided to eliminate or minimize occupational exposure to bloodborne pathogens in accordance with OSHA standard 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens."

The ECP is a key document to assist our firm in implementing and ensuring compliance with he standard, thereby protecting our employees. This ECP includes:

Determination of employee exposure
Implementation of various methods of exposure controls, including:
- Universal precautions
- Engineering and work practice controls
- Personal protective equipment
- Housekeeping
Hepatitis B vaccination
Post-exposure evaluation and follow-up
Communication of hazards to employees and training
Recordkeeping
Procedures for evaluating circumstances surrounding an exposure incident

The methods of implementation of these elements of the standard are discussed in the subsequent pages of this ECP.

Exposure Control Plan-Program Administration

_________________________ is (are) responsible for the implementation of the ECP. _____________________________ will maintain, review, and update the ECP at least annually, and whenever necessary to include new or modified tasks and procedures. Contact location/phone number: ___________________________________________________
Those employees who are determined to have occupational exposure to blood or other potentially infectious material (OPIM) must comply with the procedures and work practices outlines in this ECP.
_______________________________ will maintain and provide all necessary personal protective equipment (PPE), engineering controls (e.g., sharps containers), labels, and labeled or red bags as required by the standard. ______________________ will ensure that adequate supplies of the aforementioned equipment are available in the appropriate sizes. Contact location/phone number: _______________________________________________
__________________________ will be responsible for ensuring that all medical actions required are performed and that appropriate medical records are maintained.
Contact location/phone number: ________________________________________
__________________________ will be responsible for training, documentation of training, and making the written ECP available to employees, OSHA, and NIOSH representatives.
Contact location/phone number: ________________________________________

Notes to Employer:

The names or job titles of the program administrators should be used to ensure that authority and responsibility have been designated. In a small business, the responsibilities for the program may be held by one individual. In this case, these duties can be combined.

"Other potentially infectious materials" (OPIM) means (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any 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; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV- containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

Exposure Control Plan-Employee Exposure Determination

As part of the exposure determination section of our ECP, the following is a list of all job classifications at our establishment in which all employees have occupational exposure:

JOB TITLE	DEPARTMENT/LOCATION
________________________	________________________
________________________	________________________

The following is a list of job classifications in which some employees at our establishment have occupational exposure. Included is a list of tasks and procedures, or groups of closely related tasks and procedures, in which occupational exposure may occur for these individuals:

JOB TITLE	DEPARTMENT/LOCATION	TASK/PROCEDURE
____________	________________________	_______________
____________	________________________	_______________

All exposure determinations were made without regard to the use of PPE.

Notes to Employer:

You are not necessarily required to complete both sections A and B; you may complete only the section(s) that apply. Registered and licensed practical/vocational nurses, home health aides, and personal care providers generally fall into category A. Examples of category B would include secretarial or housekeeping staff who handle laboratory specimens or contaminated waste (e.g. sharps containers) only when they are brought into the agency office form a client's home, or office staff who are expected to clean contaminated durable medical equipment. See paragraph (c)(2) of the standard for Exposure Determination.

"Good Samaritan" acts are unanticipated events that occur when employees who do not have occupational exposure are exposed to blood or OPIM (e.g., assisting a client's child with a nosebleed). These are not included in the scope of the bloodborne pathogens standard. OSHA, however, encourages employers to offer post-exposure evaluation and follow-up in such cases.

Part-time, temporary, contract and per diem employees are covered by the standard. How the provisions of the standard will be met for these employees should be described in the ECP.

Exposure Control Plan-Methods of Implementation

II. METHODS OF IMPLEMENTATION AND CONTROL

Universal Precautions
All employees will utilize universal precautions. Universal precautions is an infection control method which requires employees to assume that all human blood and specified human body fluids (OPIM) are infectious for HIV, HBV, HCV, and other bloodborne pathogens, and must be handled accordingly.
Exposure Control Plan
1. Employees covered by the bloodborne pathogens standard will receive an explanation of this ECP during their initial training session. It will also be reviewed in their annual refresher training. All employees will have an opportunity to review this plan at any time during their work shifts by contacting ___________________________ A copy of the plan will be made available free of charge and within 15 days of the request.
2. ______________________ will be responsible for reviewing and updating the ECP annually or more frequently if necessary to reflect any new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with occupational exposure.
Engineering Controls and Work Practices
1. Engineering controls and work practice controls will be used to prevent or minimize exposure to bloodborne pathogens. The specific engineering controls and work practice controls which we will use, and where they will be used, are listed below:
  
  *__________________________________________________
  
  *__________________________________________________
  
  *__________________________________________________
  
  *__________________________________________________
2. Sharps disposal containers in the office will be inspected and maintained or replaced by _______________________ every _______________ or whenever necessary to prevent overfilling.

This facility identifies the need for changes in engineering control and work practices through: __________________________________________

We evaluate need procedures or new products by:________________ __________________________________________________________

The following staff are involved in this process: __________________ __________________________________________________________

__________________________________ will ensure effective implementation of these recommendations.

Personal Protective Equipment (PPE)
1. PPE will be provided at no cost to employees. Training will be provided by _________________ in the use of the appropriate PPE for the tasks or procedures employees will perform.
2. The types of PPE available to employees are as follows:
  __________________________________________________________
  
  __________________________________________________________
3. PPE is located ________________________________ and may be obtained through _________________________________________. (Specify how employees are to obtain PPE, and who is responsible for ensuring that it is available.)
4. All employees using PPE must observe the following precautions:
  * Wash hands immediately or as soon as feasible after removal of gloves or other PPE.
  
  * Remove PPE after it becomes contaminated, and before leaving the work area.
  
  * Used PPE may be disposed of in the client's home or returned to the office in appropriate containers for storage, laundering, decontamination, or disposal.
  
  * Wear appropriate gloves when it can be reasonably anticipated that there may be hand contact with blood or OPIM, and when handling or touching contaminated items or surfaces; replace gloves if torn, punctured, contaminated, or if their ability to function as a barrier is compromised.
  
  * Utility gloves may be decontaminated for reuse if their integrity is not compromised; discard utility gloves if they show signs of cracking, peeling, tearing, puncturing, or deterioration.
  
  * Never wash or decontaminate disposable gloves for reuse.
  
  * Wear appropriate face and eye protection when splashes, sprays, or droplets of blood or OPIM pose a hazard to the eye, nose, or mouth.
  
  * Remove immediately or as soon as feasible any garment contaminated by blood or OPIM, in such a way as to avoid contact with the outer surface.
5. The procedure for handling contaminated PPE is as follows: (may refer to specific agency procedure by title or number and last date of review)
  ___________________________________________________________
  
  ___________________________________________________________
  
  (For example, how and where to decontaminate face shields, eye protection, resuscitation equipment)

Notes to Employer:

It is imperative that employees be provided with appropriate protection when occupational exposure is anticipated. PPE is considered "appropriate" only if it does not permit blood or OPIM to pass through or reach the employee's clothes, skin, eyes, mouth, or other mucous membranes. The type and characteristics of PPE will depend upon the task and degree of exposure anticipated. For example:

* Gloves are used when employees have contact with blood, OPIM, non-intact skin, and mucous membranes, e.g. dressing changes, bathing client with broken skin, or phlebotomy. Hypoallergenic gloves, glove liners, powderless gloves or other similar alternatives must be provided for employees who are allergic to the gloves that are normally provided.

* Masks and eye protection are used when blood or OPIM may be splashed or sprayed, e.g. suctioning, oral care, tracheostomy care.

* Protective clothing is worn to protect against contamination of the employee's personal clothing with blood or OPIM, e.g. central venous line insertion.

Employees covered by the standard who make visits to clients in their homes must be provided with appropriate PPE. For employees who have occupational exposure, gloves, gowns or aprons, and disinfectant towelettes or antiseptic hand cleanser for hand washing in the absence of running water must be provided. Employees who perform invasive procedures must additionally be provided with face masks and eye protection. Employees using disposable sharps will be provided with portable sharps disposal containers. Employees who are expected to perform CPR as a function on their job must be provided with resuscitation bags or mouthpieces.

Due to the court of appeals decision, home health employers will not be held responsible for violating those provisions of paragraph (d)(3) in the bloodborne pathogens standard which require that the employer ensure that the PPE is actually used, or that employees wear PPE.

Housekeeping

Regulated Waste is placed in containers which are closable, constructed to contain all contents and prevent leakage, appropriately labeled or color-coded (see labels), and closed prior to removal to prevent spillage or protrusion of contents during handling.

The procedure for handling sharps containers is: (may refer to specific agency procedure by title or number and last date of review)
_________________________________________________________

_________________________________________________________

_________________________________________________________
The procedure for handling other regulated waste is: (may refer to specific agency procedure by title or number and last date of review)
_________________________________________________________

_________________________________________________________

_________________________________________________________
Contaminated sharps shall be discarded immediately or as soon as possible in containers that are closable, puncture-resistant, leak-proof on sides and bottoms, and labeled or color-coded appropriately. Sharps disposal containers are available at _______________________________________________________ (must be easily accessible and as close as feasible to the immediate area where sharps are used).

Bins and pails (e.g., wash or emesis basins) must be cleaned and decontaminated as soon as feasible after visible contamination.
Broken glassware which may be contaminated must be picked up using mechanical means, such as a brush and dust pan.

Laundry

The following contaminated articles will be laundered by this company:

_____________________

Laundering will be performed by _______________________ at (time and/or location) ________________________________________________
The following laundering requirements must be met:
* handle contaminated laundry as little as possible, with minimal agitation

* place wet contaminated laundry in leak-proof, labeled or color-coded containers before transporting

* use (red bags or bags marked with biohazard symbol) if the facility where items are laundered does not use universal precautions

* wear appropriate PPE when handling and/or sorting contaminated laundry: (List appropriate PPE)___________________________________________

Labels

The following method(s) is used in this facility:

EQUIPMENT TO BE LABELED	LABEL TYPE (size, color, etc.)
___________________________	___________________________
___________________________	___________________________
(e.g. specimens, contaminated laundry, etc.)	(red bag, biohazard label, etc.)

________________________ will ensure warning labels are affixed or red bags are used as required if regulated waste or contaminated equipment is brought into the office. Employees are to notify _________________________ if they discover regulated waste containers, refrigerators containing blood or OPIM, contaminated equipment, etc. without proper labels.

Notes to Employer:

Red bags or red containers may be substituted for warning labels. Labels or red bags must be used for contaminated laundry, containers of regulated waste, refrigerators containing blood or other potentially infectious material, and other containers used to store, transport, or ship blood or OPIM. Exemptions are listed under paragraph g(1)(i)(E, F, and G).

The BIOHAZARD symbol is the required legend for labels in this section. See the bloodborne pathogens standard, section g "Communication of Hazards to Employees" for specific language about labeling requirements.

Exposure Control Plan-Hepatitis B Vaccination

III. HEPATITIS B VACCINATION

A. ______________________ will provide training to employees on hepatitis B vaccinations, addressing the safety, benefits, efficacy, methods of administrations, and availability. The hepatitis B vaccination series will be made available at no cost after training and within 10 days of initial assignment to employees who have occupational exposure to blood or OPIM unless: 1) documentation exists that the employee has previously received the series, 2) antibody testing reveals that the employee is immune, or 3) medical evaluation shows that vaccination is contraindicated.

B. However, if an employee chooses to decline vaccination, the employee must sign a declination form. Employees who decline may request and obtain the vaccination at a later date at no cost. Documentation of refusal of the vaccination is kept at______________________________________

C. Vaccination will be provided by (name and title)______________

at _____________________________________(location)__________

D. Following hepatitis B vaccinations, the health care professional's written opinion will be limited to whether the employee requires the hepatitis vaccine, and whether the vaccine was administered.

Notes to Employer:

The exact language for the declination statement can be found in Appendix A of the bloodborne pathogens standard. Employees must sign a statement when declining the vaccination.

Participation in pre-screening must not be a prerequisite for receiving the vaccine.

Employees must not be required to waive liability in order to receive the vaccine.

Hepatitis B vaccine is to be provided even if an employee declines but later requests it.

Vaccine is to be given in accordance with US Public Health Service recommendations.

Booster doses must be made available to employees if recommended in the future by USPHS.

A copy of the health care professional's written opinion, stating whether hepatitis B vaccine is indicated and/or has been received, must be provided to the employee within 15 working days. (Page A-2, or alternate form, should be returned to the employee after the first dose of the vaccine, and updated after the third dose.)

If the schedule of vaccinations has been interrupted, the entire course does not need to be restarted. According to current US Public Health Service recommendations, vaccine doses administered at longer intervals (than the recommended schedule) provide equally satisfactory protection, but optimal protection is not conferred until after the third dose. If the vaccine series is interrupted after the first dose, the second and third doses should be given separated by an interval of 3-5 months. Persons who are late for the third dose should be given this dose when convenient. Post-vaccination testing is not considered necessary in either situation. These recommendations may be updated by the USPHS; call 404-332-4555 for current information. Reasonable effort should be made to vaccinate the employee on schedule, unless the employee declines vaccination.

Post-Exposure Evaluation and Follow-up

IV. POST-EXPOSURE EVALUATION AND FOLLOW-UP

Should an exposure incident occur, contact immediately at the following number: .
An immediately available confidential medical evaluation and follow-up will be conducted by (Licensed health care professional) ______________. Following the initial first aid (clean the would, flush eyes or other mucous membrane, etc.), the following activities will be performed:

Notes to Employer:

An exposure incident is defined in the standard as "a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties." Employees may document each exposure on a form such as that provided on page A-7 of this document, EPINet Universal Blood and Body Fluid Exposure Report, and on the OSHA No. 200 log, if appropriate.

If consent is not obtained from the source individual, the employer must show that the required consent could not be obtained. Where consent is not required by law, the source individual's blood, if available, shall be tested and the results documented. This must be done whether or not the employee elects baseline testing and follow-up.

Following an exposure incident, prompt evaluation and prophylaxis is imperative. Timeliness is, therefore, an important factor in effective treatment. The American Nurses' Association Position Statement on "Post-Exposure Programs in the Event of Occupational Exposure to HIV/HBV" (September, 1991; cited with permission) includes the following Guidelines for Immediate Treatment:

1. Wound care/First Aid

A. Clean wound with soap and water.

B. Flush mucous membranes with water or normal saline solution.

C. Other wound care as indicated.

2. Notification of Responsible Parties

A. Notify supervisor or on-call staff member at the 24-hour hotline number after wound care has been provided.

Procedures for reporting an exposure should be in place which apply to any and all working hours. Following immediate wound care and supervisor notification, the post-exposure evaluation must be provided as in IV. B., above.

Administration of Post-Exposure Evaluation and Follow-Up
1. ________________________ will ensure that health care professionals responsible for employee's hepatitis B vaccination and post-exposure evaluation and follow-up be given a copy of OSHA's bloodborne pathogens standard.
2. ________________________ will ensure that the health care professional evaluating an employee after an exposure incident receives the following:
3. ________________________ will provide the employee with a copy of the evaluating health care professional's written opinion within 15 days after completion of the evaluation.

Notes to Employer:

See sample forms for post-exposure: Health Care Professional's Written Opinion for Post Exposure Evaluation, and Bloodborne Pathogen Exposure Evaluation Form.

If the employer is also the health care professional, the employer must ensure that the results of the employee's post-exposure evaluation remain confidential and are not disclosed to his/her co-workers, managers and supervisors, except to the extent absolutely necessary to comply with the standard or other legal requirements.

Post-exposure counseling is mandatory under the standard. The American Nurses' Association recommendations for exposed health care worker counseling are provided as an example. (From the Position Statement on Post-Exposure Programs, September, 1991.)

* Counseling should be provided by skilled personnel through previously established agency protocol.
* Counseling should include the following: meaning of test results; discussion of personal life factors such as safer sex practices, conception/contraception, and informing sexual partners; discussion regarding avoidance of blood, semen, and tissue donation.
* Counseling should include a validation of the health care workers' concerns and fears, and the implications of disclosure to other persons in their support system.
* The health care worker should be encouraged to monitor for signs/symptoms of acute sero-conversion illness (fevers, myalgias, rash, etc.) and to report these symptoms to designated personnel immediately.
* Information regarding workers' compensation, disability, and other benefits should be provided.

V. Procedures for Evaluating the Circumstances Surrounding an Exposure Incident

________________________ will review the circumstances of all exposure incidents to determine:
* engineering controls in use at the time

*Work practices followed

*A description of the device being used

*Protective equipment or clothing that was used at the time of the exposure incident (gloves, eye shield, etc.)

*Location of the incident (O.R., E.R., patient room, etc.)

*Procedure being performed when the incident occurred

*Employee's training
If it is determined that revisions need to be made, ___________________ will ensure that appropriate changes are made to this ECP. (Changes may include an evaluation of needleless systems, adding employees to the exposure determinations list, etc.)

Employee Training

VI. Employee Training

All employees who have occupational exposure to bloodborne pathogens will receive training conducted by ___________________________

(name and title, attach a brief description of their qualifications.)

All employees who have occupational exposure to bloodborne pathogens will receive training on the epidemiology, symptoms, and transmission of bloodborne pathogen diseases. In addition, the training program will cover, at a minimum, the following elements:
Training materials for this facility are available at ____________________

Recordkeeping:

The training materials, such as overheads, workbooks, and handouts may be included in the ECP. Self-study modules, videos, and interactive computer programs may all be used as part of the training program. However, a person knowledgeable in the subject matter and who can accurately answer employee questions must be accessible for interaction during the training session.

Training Records
1. Training records will be completed for each employee upon completion of training. These documents will be kept with the employee's records at ____________________. (See page A-6 for sample form.)
2. Training records will be maintained by _________________________.
3. The training records shall include:
  * the dates of the training sessions
  * the contents or a summary of the training sessions
  * the names and qualifications of persons conducting the training
  * the names and job titles of all persons attending the training sessions
4. Training records will be maintained for a minimum of three (3) years from the date on which the training occurred.
5. Employee training records will be provided upon request to the employee or the employee's authorized representative within 15 working days.

Note to Employer:

Training shall be provided:

* at initial assignment to tasks where occupational exposure may take place
* when new exposure is created by a change in tasks or procedures
* at least annually after initial training
* at no cost to the employee, during work hours
* with material appropriate to educational level, literacy, and language of employees
* by a person knowledgeable in the subject matter being presented, as it relates to home care

Recordkeeping

VII. Recordkeeping:

Training Records

Training records will be completed for each employee upon completion of training. These documents will be kept for at least Three years at____________________________________________________
The training records shall include:
* the dates of the training sessions
* the contents or a summary of the training sessions
* the names and qualifications of persons conducting the training
* the names and job titles of all persons attending the training sessions
Employee training records will be provided upon request to the employee or the employee's authorized representative within 15 working days. Such requests should be addressed to ____________________________

Medical Records

Medical records are maintained for each employee with occupational exposure in accordance with 29 CFR 1910.20, "Access to Employee Exposure and Medical Records."

__________________________________is responsible for maintenance of the required medical records. These confidential records are kept at________________________ for at least the duration of employment plus 30 years.

Employee medical records will be provided upon request to the employee or to anyone having written consent of the employee within 15 working days. Such requests should be addressed to ____________________________

OSHA Recordkeeping

An exposure incident is evaluated to determine if the case meets OSHA's Recordkeeping Requirements (29 CFR 1904). This determination and the recording activities are done by: ______________________________________________________

Health Care Professionals
Written Opinion For Hepatitis B Vaccination

Employee Name:______________________________________________
Date of Office Visit:___________________________________________
Health Care Facility Address: ___________________________________
Health Care Facility Telephone: _________________________________

As required under the bloodborne pathogen standard:

Hepatitis B vaccination is ____ is not ____ recommended for the employee named above.

The employee named above is scheduled to receive the hepatitis B vaccination on
the following dates:

First of three ___________
Second of three_________
Third of three___________

Signature of health care provider:____________________________________

Printed or typed name of health care provider:__________________________

This form is to be returned to the employer, and a copy provided to the employee within 15 days.

Employer Name:______________________________

Title:_______________________________________

Address:_________________________________________________________

*This form was taken from: Model Exposure Control Plan for Home Care: A Guide for Hospice/Home Agencies on the Bloodborne Pathogens Standards. OSHA Office of Occupational Nursing, 1994.

Bloodborne Pathogen Exposure Evaluation Form

(Send with employee at the time a health evaluation is needed. Form to be completed and kept by health care provider only. Information on this form is confidential. Do not send this form to employer.)

Employee Name:___________________ Today's Date:_______________
Social Security Number:_____________ Date of Birth:_______________
Home Phone:______________________
Job Title: _________________________
Date of Exposure: __________________

(See Exposure Report for circumstances under which exposure incident occurred)

Yes / No Blood of source individual has been tested with consent of individual as applicable. If no, please explain and/or indicate if HIV and/or HBV is already known.

________________________________________________________________

Yes / No Results of sources individual's testing conveyed to employee.

(Explain)_________________________________________________________

Yes / No Employee informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source.

(Explain)_________________________________________________________

Yes / No Exposed employee's blood collected and tested with obtained consent.

(Explain)_________________________________________________________

Yes / No If employee declines HIV testing, blood stored for 90 days from exposed incident.

(Explain)_________________________________________________________

Yes / No Post-exposure prophylaxis initiated if medically indicated.

(Explain)_________________________________________________________

Yes / No Hepatitis B vaccination is indicated. Elaborate on treatment given:________________________________________________________________

Status of employee vaccination:
One of three: Date________ Type__________ Lot#__________Site_______ Administered by:____________________________________

Two of three: Date________ Type___________ Lot#__________Site_______
Administered by:____________________________________

Three of three: Date________ Type__________ Lot#__________Site_______
Administered by:____________________________________

Yes / No Employee informed of results of evaluation. (Explain)________________________________________________

Yes / No Employee has been informed of any health conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment. (Explain)_________________________________________________

Assessment/Observations/Plan:

__________________________________________________________________

Action: _____ Confidential post-exposure evaluation entered into
employee's individual health record.

_____ Copy of health care professional's written opinion
for post-exposure evaluation completed and sent to employer.

_____ Copy of health care professional's written opinion
for post-exposure evaluation given to employee.

NOTE: all other findings shall remain confidential and shall not be included.

This form was taken from: Model Exposure Control Plan for Home Care: A Guide for Hospice/Home Agencies on the Bloodborne Pathogens Standards. OSHA Office of Occupational Nursing, 1994.

Health Care Professionals
Written Opinion For Post-Exposure Evaluation*

Employee Name:______________________________________________
Date of Incident:_____________________________________________
Date of Office Visit:___________________________________________
Health Care Facility Address: ___________________________________
Health Care Facility Telephone: _________________________________

As required under the Bloodborne Pathogen Standard:

______ The employee named above has been informed of the results of the post-exposure health evaluation.

______ The employee named above has been told about any health conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment.

______ Hepatitis B vaccination is ____ is not ____ indicated.

Signature of health care provider:_______________________ Date: ________

Printed or typed name of health care provider:___________________________

This form is to be returned to the employer, and a copy provided to the employee within 15 days.

Employer Name:______________________________

Title:_______________________________________

Address:_________________________________________________________

*This form was taken from: Model Exposure Control Plan for Home Care: A Guide for Hospice/Home Agencies on the Bloodborne Pathogens Standards. OSHA Office of Occupational Nursing, 1994.

Hepatitis B Declination Statement

The following statement of declination of hepatitis B vaccination must be signed by an employee who chooses not to accept the vaccine. The statement can only be signed by the employee following appropriate training regarding hepatitis B, hepatitis B vaccination, the efficacy, safety, method of administration, and benefits of vaccination, and that the vaccine and vaccination are provided 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.

Declination Statement

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 (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis B vaccine, at no charge 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 charge to me.

Employee Signature:_____________________________ Date:____________________

*Taken from:Bloodborne Pathogens and Acute Care Facilities OSHA Publication 3128, (1992).

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