appendix Occupational Safety and Health Administration Regulations on Occupational Exposure to Bloodborne Pathogens

In 1970, the U.S. Congress enacted the Occupational Safety and Health Act to protect workers from unsafe and unhealthy conditions in the work­place. To oversee this effort, the law also created the Occupational Safety and Health Administration (OSHA) within the U.S.

In December 1991, OSHA issued new regulations on occupational exposure to bloodborne pathogens that are designed to minimize the transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and other potentially infectious materials in the workplace. The regulations cover all employees in physician offices, hospitals, medi­cal laboratories, and other health care facilities where workers could be

“reasonably anticipated” as a result of performing their job duties to come into contact with blood and other potentially infectious materials. The reg­ulations were revised, effective April 2001, to comply with the Needlestick Safety and Prevention Act of 2000.

Approved State Plans

Under the federal law that created OSHA, states are encouraged to develop and operate—under OSHA guidance—state job safety and health plans. Currently, 25 states and 2 other jurisdictions have OSHA-approved plans, which require them to provide standards and enforcement programs that are at least as effective as the federal standards.

• Alaska

• Arizona

• California

• Connecticut

• Hawaii

• Illinois

• Indiana

• Iowa

• Kentucky

• Maryland

• Michigan

• Minnesota

• Nevada

• New Jersey

• New Mexico

• New York

• North Carolina

• Oregon

• Puerto Rico

• South Carolina

• Tennessee

• Utah

• Vermont

• Virgin Islands

• Virginia

• Washington

• Wyoming

A list of these state OSHA offices is available on the OSHA web site at www.osha.gov/dcsp/osp/states.html; call the number listed to receive a copy of the state’s standards on occupational exposure to bloodborne pathogens. In Connecticut, Illinois, New Jersey, New York, and the Virgin Islands the state plans cover state and local government employees only; the private sector is covered by the federal OSHA standard. In addition, states with an OSHA-approved state plan must comply with the federal OSHA standard.

Complying With Regulations

Exposure Control Plan

In order to comply with the regulations, health care employers are required to prepare a written “Exposure Control Plan” designed to eliminate or minimize employee exposure to bloodborne pathogens. This plan must list all job classifications in which employees are likely to be exposed to infec­tious materials and the relevant tasks and procedures performed by these employees. Infectious materials include blood, semen, vaginal secretions, peritoneal fluid, amniotic fluid, any body fluid visibly contaminated with blood, all body fluids in which it is impossible to differentiate between the body fluids, any unfixed human tissue or organ (living or dead), as well as HIV-containing cell or tissue cultures, organ cultures, and HIV-containing or HBV-containing culture medium or other solutions.

Under the plan, employers are required to adopt universal precautions, engineering and work practice controls, and personal protective equipment requirements. Employers also must establish a schedule for implementing the following controls:

• Housekeeping requirements

• Employee training and record-keeping requirements

• Hepatitis B virus vaccination for employees and postexposure evalu­ation and follow-up procedures

• Communication of hazards

A detailed discussion of each of these requirements follows.

Mandatory Universal Precautions

The regulations require that universal precautions must be used to prevent contact with blood or other potentially infectious materials. It is OSHA’s intention to follow the Centers for Disease Control and Prevention’s guidelines on universal precautions. As defined by the Centers for Disease Control and Prevention, the concept of universal precautions requires the employer and employee to assume that blood and other body fluids are infectious and must be handled accordingly.

Engineering and Work Practice Controls

Specific engineering and work practice controls for the workplace must be implemented and examined for effectiveness on a regular schedule. These include the following controls:

1. Employers are required to provide hand-washing facilities that are readily accessible to employees; when this is not feasible, employees must be provided with an antiseptic hand cleanser with clean cloth or paper towels or antiseptic towelettes. It is the employer’s respon­sibility to ensure that employees wash their hands immediately after gloves and other protective garments are removed.

2. Contaminated needles and other contaminated sharp objects shall not be bent, recapped, or removed unless the employer can dem­onstrate that no alternative is feasible or that a specific medical procedure requires such action.

3. Eating, drinking, smoking, applying cosmetics or lip balm, and han­dling contact lenses are prohibited in work areas where there is a reasonable likelihood of exposure to potentially infectious materials.

4. Food and drink must not be kept in refrigerators, freezers, shelves, cabinets, or on countertops where blood or other potentially infec­tious materials are present.

5. All procedures that involve blood or other infectious materials shall be performed in a manner to minimize splashing, spraying, spatter­ing, and creating droplets; mouth pipetting and suctioning of blood or other potentially infectious materials is prohibited.

6. Specimens of blood or other potentially infectious materials must be placed in closed containers that prevent leakage during collection, handling, processing, storage, transport, or shipping; containers must be labeled or color coded in accordance with the regulations for easy identification. However, when a facility uses universal precautions in the handling of all specimens, the required labeling or color coding of specimens is not necessary as long as containers are recognizable as containing specimens; this exemption applies only while the speci­mens and containers remain in the facility. If outside contamination of the primary container occurs, it must be placed within a second container that is leakproof, puncture resistant, and labeled or color coded accordingly.

7. Equipment that could be contaminated with blood or other infectious materials must be examined before servicing or shipping and shall be decontaminated as necessary, unless the employer can demonstrate that decontamination of the equipment or parts of the equipment is not feasible.

Personal Protective Equipment

The regulations also stress the importance of appropriate personal pro­tective equipment that employers are required to provide at no cost to employees whose job duties expose them to blood and other infectious materials. Appropriate personal protective equipment includes but is not limited to gloves, gowns, laboratory coats, face shields or masks, eye pro­tection, mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. As defined by OSHA, personal protective equipment is considered “appropriate” if it prevents blood or other potentially infectious materials from reaching an employee’s work clothes and skin, eyes, mouth, or other mucous membranes under normal conditions of use.

Employers must ensure that the employee uses appropriate personal pro­tective equipment unless the employer can demonstrate that the employee temporarily declined to use the equipment, when under rare and extraor­dinary circumstances, it was the employee’s professional judgment that use of personal protective equipment would have prevented the delivery of health care services or would have posed an increased hazard to the safety of the worker or co-worker. When an employee makes this judgment, the circumstances shall be investigated and documented in order to determine whether changes can be made to prevent such situations in the future.

Personal protective equipment in the appropriate sizes must be acces­sible at the worksite or issued to employees. Hypoallergenic gloves, glove liners, powderless gloves, or other similar alternatives, shall be accessible to those employees who are allergic to the gloves normally provided.

Gloves must be worn when it can reasonably be anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and nonintact skin; when performing vascular access procedures; and when handling or touching contaminated surfaces. Disposable gloves shall be replaced as soon as practical when contaminated or when torn or punctured; they shall not be washed or decontaminated for reuse. Utility gloves may be decontaminated for reuse but must be discarded if a glove is cracked, peeling, torn, punctured, or shows other signs of deterioration.

Masks in combination with goggles or protective eye shields must be worn whenever splashes, spray, spatter, or droplets of blood may be cre­ated and eye, nose, or mouth contamination can reasonably be anticipated. Gowns and other protective body clothing such as, but not limited to, gowns, aprons, lab coats, clinic jackets, or similar outer garments, shall be worn in occupational exposure situations. The type and characteristics will depend upon the task and degree of exposure anticipated. Surgical caps, hoods, shoe covers, or all three must be worn in situations in which gross contamination can reasonably be anticipated (eg, autopsies, orthopedic surgery).

Housekeeping

Employers must ensure that the worksite is maintained in a clean and sanitary condition and shall develop and implement a written schedule for cleaning and method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area. All equipment and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials.

Contaminated work surfaces shall be decontaminated with an appro­priate disinfectant after tasks and procedures are completed; immediately or as soon as feasible when surfaces are contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last clean­ing. Protective covering (eg, plastic wrap, aluminum foil, or imperviously backed absorbent paper used to cover equipment and environmental sur­faces) must be removed and replaced as soon as feasible upon contamina­tion or at the end of the work shift if they may have become contaminated during the shift. All bins, pails, cans, and similar containers intended for reuse shall be inspected and decontaminated on a regularly scheduled basis and cleaned immediately or as soon as feasible upon visible contamination.

Broken glassware that may be contaminated must not be picked up directly with the hands; it must be cleaned up using a brush and dustpan, tongs, or forceps. Contaminated reusable sharp objects must not be stored or processed in a manner that requires employees to reach by hand into the containers in which these sharp objects have been placed. Containers for contaminated sharp objects must be closable, puncture resistant, leakproof on the sides and bottom, and labeled or color coded in accordance with the regulations. During use, containers for contaminated sharp objects shall be easily accessible to personnel and located as close as possible to the immediate area where sharp objects are used. Additionally, these contain­ers must be maintained upright throughout use, replaced routinely, and not be allowed to be overfilled. Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner that would expose employees to the risk of percutaneous injury. Containers of contaminated disposable sharp objects and personal protective equipment are defined as regulated waste; such containers must prevent the spillage or protrusion of contents during handling, storage, transport, or shipping.

Contaminated laundry shall be handled as little as possible and must be placed in bags or containers at the location where it was used; it must not be sorted or rinsed in the location of use. Contaminated laundry shall be transported in clearly labeled or color-coded bags or containers in accordance with the regulations. Employers shall ensure that employees who have contact with contaminated laundry wear protective gloves and other appropriate personal protective equipment. When a facility ships contaminated laundry offsite to a second facility that does not use univer­sal precautions in handling all laundry, the facility generating the contami­nated laundry must clearly mark or color code the bags or containers with appropriate biohazard labels.

Hepatitis B Vaccination

Employers are required to provide HBV vaccination free of charge to all employees who are at risk of occupational exposure. The vaccine must be provided within 10 days of an employee’s initial assignment, except in the following cases:

• The employee has previously received the complete HBV vaccina­tion series.

• Antibody testing has revealed that the employee is immune.

• The vaccine is contraindicated for medical reasons.

The regulations prohibit employers from making employees partici­pate in a prescreening program as a prerequisite for receiving the vaccine. Employees who refuse the vaccination must sign a “Hepatitis B Vaccine Declination” form stating that they have declined the vaccine. If the U.S. Public Health Service ever recommends booster doses of HBV vaccine, they also must be provided to employees free of charge. The employee, how­ever, is allowed to change his or her mind and elect to receive the vaccine at any time at the employer’s expense.

Postexposure Evaluation and Follow-up

Following a report of an employee exposure incident, the employer must make immediately available to the exposed employee a confidential medi­cal evaluation at no cost to the employee and at a reasonable time and place, and follow-up, including at least the following information and follow-up care:

1. Documentation of the route(s) of exposure and the circumstances under which the exposure occurred

2. Identification and documentation of the individual who is the source of the blood or potentially infectious material, unless the employer can establish that such identification is not feasible or is prohibited by state or local law. The source individual’s blood shall be tested as soon as possible and after consent is obtained, in order to determine HBV or HIV infectivity. If consent is not obtained, the employer must document that legally required consent cannot be obtained. If the source individual’s consent is not required by law, the source individ­ual’s blood if available must be tested and the results documented. However, when the source individual is already known to be infected with HBV or HIV, blood testing for HBV or HIV is not required. Results of the source individual’s blood test must be made available to the exposed employee, and the employee shall be informed of all applicable laws concerning the disclosure of the source individual’s identity and infectious status.

3. Collection and testing of the exposed employee’s blood for HBV and HIV serologic status as soon as feasible after the employee gives con­sent. If the employee consents to baseline blood collection but does not give consent at that time for HIV serologic testing, the sample shall be preserved for 90 days. Testing of the blood shall take place within the 90 days if the employee decides to do so.

4. Postexposure prophylaxis when medically indicated, as recommended by the U.S. Public Health Service

5. Counseling

6. Evaluation of reported illnesses

The employer must ensure that the health professional responsible for the employee’s HBV vaccination is provided a copy of the OSHA regulation on bloodborne pathogens. In the case of a health professional evaluating an exposed employee, the employer shall ensure that the health profes­sional is provided the following information:

• A copy of the OSHA bloodborne pathogens regulations

• A description of the exposed employee’s duties as they relate to the exposure incident

• Documentation of the routes of exposure and circumstances under which exposure occurred

• Results of the source individual’s blood testing, if available

• All medical records relevant to the appropriate treatment of the exposed employee, including vaccination status, which is the employer’s responsibility to maintain

The employer must obtain and provide the employee with a copy of the evaluating health professional’s written opinion within 15 days of comple­tion. The health professional’s written opinion for HBV vaccination shall be limited to whether HBV vaccination is indicated for the employee and if the employee has received such vaccination. The health professional’s written opinion for postexposure evaluation and follow-up shall be limited to the following information:

• The employee has been informed of the results of the evaluation.

• The employee has been told about any medical conditions result­ing from exposure to blood or other potentially infectious materials that require further evaluation or treatment.

All other findings or diagnoses must remain confidential and shall not be included in the written report.

Communications of Hazards to Employees

Warning Labels and Signs

The regulations require warning labels on containers of regulated waste and refrigerators and freezers that contain blood or other potentially infec­tious materials. Warning labels also must be affixed to containers used to store, transport, or ship blood or other potentially infectious materials. The warning labels must be fluorescent orange or orange-red; however, red bags or red containers may be substituted for labels.

Employee Training

Employers must ensure that all employees at risk of occupational exposure participate in a training program at no cost to employees and during work­ing hours. Training shall take place at the time of an employee’s initial

assignment to tasks that risk exposure and at least annually thereafter. Annual training for employees shall be provided within 1 year of their previous training. Additional training must be provided when changes, such as modifications of tasks or procedures or introduction of new tasks and procedures, affect the worker’s exposure risk. The training must be conducted by a person knowledgeable about the subject matter, and the material shall be presented at an educational level appropriate to the employees. The training program at a minimum must include the follow­ing information:

1. A copy of the bloodborne pathogens regulations and an explanation of their contents

2. A general explanation of the epidemiology and symptoms of blood­borne diseases

3. An explanation of the modes of transmission of bloodborne diseases

4. An explanation of the employer’s Exposure Control Plan and infor­mation on how the employee can obtain a copy of the plan

5. An explanation of the appropriate methods for identifying tasks and other activities that may involve exposure

6. An explanation of the methods that will prevent or reduce exposure (including appropriate engineering controls, work practices, and personal protective equipment)

7. Information on the types, proper use, location, removal, handling, decontamination, and disposal of personal protective equipment

8. An explanation of the basis for selection of personal protective equipment

9. Information on the HBV vaccine (efficacy, safety, method of admin­istration, benefits of being vaccinated, and that the vaccine will be offered free of charge)

10. Information on the appropriate actions to take and individuals to contact in an emergency that involves blood or other infectious materials

11. An explanation of the procedure for follow-up if an exposure inci­dent occurs (including the method for reporting incident and the medical follow-up that may be available)

12. Information on the postexposure evaluation and follow-up that the employer is required to provide for the employee

13. An explanation of the signs and labels, color-coding requirements, or both

14. An opportunity for interactive questions and answers with the per­son conducting the training session

Record-Keeping Requirements

The employer shall maintain an accurate record for each employee at risk of occupational exposure that includes the following information:

• The name and social security number of employee

• The employee’s HBV vaccination status (dates and any medical information relative to the employee’s ability to receive the vaccination)

• The results of examinations, medical testing, and follow-up procedures

• The employer’s copy of the health professional’s written evaluation as required following an exposure incident

• A copy of the information provided to the health professional as required following an exposure incident

The employer shall ensure the confidentiality of employee records; information shall not be disclosed without the employee’s written con­sent. The employer is required to maintain records for the duration of employment plus 30 years. The employer also must maintain records of the training sessions that include the dates, the names and qualifications of individuals who conducted training sessions, and the names and job titles of employees who attended sessions. These records shall be maintained for 3 years from the date the training session occurred.

All records shall be made available to the assistant secretary of OSHA for examination and copying, including employee medical records, for which the employee’s consent is not needed. In the event of an employer going out of business, these records must be transferred to the new owner or must be offered to the National Institute for Occupational Safety and Health.

Sharps Injury Log

An employer with more than 10 employees shall maintain a “sharps injury log” to record percutaneous injuries from contaminated sharps. The information in the log shall be kept in a way to protect the confidentiality of the injured employee. The log must contain:

• 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

The bloodborne pathogens regulations are just one of the OSHA stan­dards that physician offices must follow to be in compliance. Other OSHA regulations include standards on the hazards of chemicals in the work­place, compressed gases, office equipment, and an action plan in case of fire. An emergency hotline number has been established by OSHA to report emergencies: 1-800-321-OSHA (6742).