Authority and Responsibility
Environmental Health and Safety has the primary responsibility and authority for the implementation and enforcement of the Bloodborne Pathogen Exposure Control Plan and is responsible for:
- Reviewing and revising the Bloodborne Pathogen Exposure Control Plan annually;
- Providing Bloodborne Pathogen training for affected University employees;
- Ensuring compliance with the Exposure Control Plan during laboratory and building inspections;
- Identifying appropriate personal protective equipment (PPE)
- Maintaining training records for three years from the date on which training occurred; and
- Evaluating safer medical devices.
Departments with employees affected by this program are responsible for:
- Ensuring that all affected employees meet the annual Bloodborne Pathogen training requirement;
- Providing department specific information and training relating to hazard communication for affected University employees;
- Ensuring engineering controls are properly maintained and/or replaced; and
- Providing PPE.
Principal Investigators are responsible for:
- Developing lab-specific standard operating procedures (SOPs) to ensure compliance with the Exposure Control Plan;
- Providing lab-specific safety training to employees upon initial work assignment;
- Reviewing SOPs annually to reflect new or modified tasks, procedures, or technology that eliminate or reduce exposure to bloodborne pathogens; and
- Documenting annually the consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure.
Employees are responsible for:
- Complying with the Bloodborne Pathogen Exposure Control Plan;
- Participating in the University’s annual Bloodborne Pathogen training session and department specific training sessions;
- Understanding which tasks have potential occupational exposure; and
- Using and maintaining PPE.
University Human Resources (HR) is responsible for:
- Maintaining a sharps injury log for University employees, including Biological Sciences Division employees.
University of Chicago Occupational Medicine (UCOM) is responsible for:
- Maintaining medical records of each employee with occupational exposure.
Employee Exposure Determination
A list of University employee job classifications which have the potential for occupational exposure to blood or OPIM can be found in the Employee Exposure Determination Matrix. Two groups are shown: Group 1 lists job classifications in which all employees have occupational exposure and Group 2 lists job classifications in which there is occupational exposure while performing certain tasks/duties.
Methods of Compliance
Universal Precautions Controls
Universal precautions shall be observed in all situations where there is potential for contact with blood or OPIM. Under circumstances where body fluids are difficult or impossible to differentiate (e.g., dark areas), all such fluids shall be considered potentially infectious.
Engineering controls are used to eliminate or minimize employee exposure by isolating or removing bloodborne pathogens from the workplace. To ensure their effectiveness, all engineering controls shall be examined and maintained or replaced on a scheduled basis by each department.
Engineering controls include, but are not limited to, the following:
- Biological safety cabinets to protect workers from possible inhalation of aerosolized infectious agents;
- Re-sheathable needles that encase the needle immediately after use to prevent needlestick injuries and exposures;
- Sharps disposal containers located at the point of use to prevent injury or exposure during transportation of contaminated sharps;
- Secondary leak proof containers used during transportation to help prevent spills if the primary container breaks;
- Needleless systems; and
- Sharps with engineered sharps injury protections (SESIP).
Handwashing facilities shall be present and readily accessible to employees. When not feasible, an appropriate antiseptic hand cleanser in conjunction with clean cloth/paper towels or antiseptic towelettes shall be provided. When hand cleansers or towelettes are used, hands shall be washed with soap and running water as soon as feasible.
Work Practice Controls
Work practice controls involve altering the manner in which the job is being performed. Correct work procedures include, but are not limited to, the following:
- Proper handling and disposal of needles, sharps, used bandages and gauze, linens, and all other any items that come in contact with blood or OPIM;
- Recapping, removing, bending, shearing, or breaking needles is prohibited (Note: If needle recapping is absolutely necessary such as with incremental doses of medication or the injection of radioactive materials, a one-handed method or mechanical device approved for this purpose shall be used.);
- Passing uncapped needles to others is prohibited. If a needle needs to be passed, it should be set down on a surface for the next person to pick up to reduce the potential for sticking the recipient;
- Wearing gloves whenever handling tissues, body fluids, or OPIM;
- Regular handwashing is recommended even when personal protective equipment such as gloves are removed;
- Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses is prohibited in work areas where there is a reasonable likelihood of occupational exposure;
- Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or OPIM are present;
- All procedures involving blood or OPIM shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances;
- Wash hands and any other skin with soap and water or flush mucous membranes with water immediately or as soon as feasible following contact of such body areas with blood or other potentially infectious materials;
- Mouth pipetting/suctioning of blood or OPIM is prohibited;
- Specimens of blood or OPIM shall be placed in a container that prevents leakage during collection, handling, processing, storage, transport, or shipping;
- If a specimen could puncture the primary container, the primary container shall be placed within a secondary container, which is puncture-resistant and labeled or color-coded;
- If outside contamination of the primary container occurs, the primary container shall be placed within a second container that prevents leakage during handling, processing, storage, transport, or shipping, and is labeled or color-coded;
- Equipment that has been contaminated with blood or OPIM shall be decontaminated before being serviced or shipped unless it can be shown that decontamination of the equipment is not feasible. Equipment, or portions thereof that are not decontaminated, require that a protective film be wrapped around the equipment and a warning label be affixed; and
- Laboratory samples (e.g., biological, chemical) shall not be stored in off-site refrigerators outside of the laboratory (e.g., home, personal offices).
The worksite shall be maintained in a clean and sanitary condition. A written schedule for cleaning and a method of decontamination, based on the location, type of surface, type of soil present, and procedures being performed in each area shall be present.
All equipment and working surfaces will be cleaned and decontaminated after contact with blood or OPIM.
The process of decontamination shall be conducted as follows:
- After completion of procedures;
- When surfaces are overtly contaminated;
- After the spill of blood or OPIM; and
- At the end of the work shift, if the surface may have become contaminated since the last cleaning.
The common disinfectant used is a 10% bleach and water solution consisting of approximately two cups chlorine bleach in one gallon of water. Avoid splashing while pouring or handling bleach. Utilize a misting spray bottle and apply the bleach solution over the entire contaminated area, cover it with paper towels, and allow thirty minutes of contact time. Consult the Selected EPA-registered Disinfectants for alternatives.
Protective coverings such as plastic wrap or aluminum foil shall be removed and replaced at the end of the work shift if they may have become contaminated during the shift or whenever they become visibly contaminated.
Any bins, pails, cans, or other similar receptacles intended for re-use will be inspected and decontaminated before re-use.
Broken glassware shall be handled with the aid of a mechanical device (e.g., brush and dustpan, tongs, or forceps). The mechanical device shall be decontaminated if possible or discarded in accordance with the Potentially Infectious Waste policy.
Personal Protective Equipment (PPE)
Personal protective equipment shall be used in all occupational exposure situations where there is the potential for the employee to come in contact with potentially infectious materials.
Personal protective equipment shall be considered “appropriate” only if it does not permit blood or OPIM 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.
General rules on personal protective equipment are as follows:
- Employees shall be trained how to use personal protective equipment properly;
- Personal protective equipment shall be appropriate for the task;
- Personal protective clothing and equipment shall be suitable so that the level of protection fits the expected exposure (e.g., gloves would be sufficient for a laboratory technician who is drawing blood while a pathologist conducting an autopsy would need considerably more protective clothing);
- The University shall provide, repair, or replace personal protective equipment as needed to maintain its effectiveness at no cost to the employee;
- All personal protective equipment shall be available in the appropriate sizes and readily accessible at the worksite or issued to the employees; and
- If a garment(s) is penetrated by blood or OPIM, the garment shall be removed and replaced immediately or as soon as feasible.
Gloves shall be worn when it can be reasonably anticipated that the employee may have contact with blood, OPIM, non-intact skin, and when handling or touching contaminated items or surfaces.
Gloves shall be made of water impervious materials such as latex, nitrile, or rubber. Hypoallergenic gloves, glove liners, powderless gloves, and other similar alternatives shall be readily accessible to employees who are allergic to gloves normally provided.
Cuts and open sores shall be bandaged before donning gloves since gloves can be punctured by sharps.
When using disposable, single use gloves, replace them as soon as practical or when they become visibly contaminated, torn, punctured, or when their ability to function as a barrier is compromised. Disposable gloves shall not be washed or decontaminated for re-use.
Utility gloves may be decontaminated for re-use if the integrity of the glove is not compromised. Utility gloves shall be discarded if they are cracked, peeling, torn, punctured, or if they exhibit other signs of deterioration or when their ability to function as a barrier is compromised.
Gloves shall be removed prior to exiting the laboratory and before touching public objects such as telephones, elevator buttons, or door handles to avoid cross contamination.
When performing procedures that are likely to generate splashes, spray, spatter, or droplets of blood or OPIM, protective eyewear such as goggles, glasses, or face shields shall be worn to protect the eyes.
Face shields can be used to protect from splashes to the nose and mouth in addition to the eyes.
Gowns, aprons, lab coats, clinic jackets, or other protective body clothing shall be worn when performing procedures likely to generate splashes or splatters of blood or body fluids and in all occupational exposure situations. Gowns and laboratory coats are used to protect clothing from being contaminated by fluids and soaking through to the skin.
Respiratory devices and pocket mouthpieces are types of personal protective equipment designed to isolate contact from the victim’s saliva during resuscitation.
Surgical Caps/Shoe Covers
Surgical caps or hoods and/or shoe covers or boots shall be worn in instances when gross contamination can reasonably be anticipated (e.g., autopsies, orthopedic surgery).
Proper Disposal of Personal Protective Equipment
Personal protective equipment shall be removed prior to leaving the work area. When personal protective equipment is removed, it shall be placed in an appropriate designated area or container for storage, washing, decontamination, or disposal.
All soiled laundry and personal protective equipment shall be placed in labeled or color-coded leak-proof bags or containers without sorting or rinsing.
Cleaning, laundering, repair, replacement, or disposal of personal protective equipment shall be provided at no cost to the employee.
Each department is responsible for securing contracted services for regular washing of laboratory coats and gowns if reusable coats and/or gowns are used.
Exceptions to Wearing Personal Protective Equipment
Personal protective equipment may be temporarily or briefly declined under rare and extraordinary circumstances where using personal protective equipment may prevent proper delivery of healthcare or public safety services or where personal protective equipment may pose an increased hazard to the safety of the employee.
Situations in which personal protective equipment was temporarily or briefly declined shall be investigated and documented to determine if changes can be instituted to prevent future occurrences.
Regulated Waste Management
All regulated waste handling, storing, transporting, or shipping shall be labeled properly.
If outside contamination of the regulated waste container occurs, it shall be placed in a secondary container that is closable and constructed to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipping. The container shall be labeled or color-coded and closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping.
Potentially infectious waste shall be processed in accordance with the Potentially Infectious Waste policy.
Contaminated Sharps Disposal
Sharps shall be disposed of in designated containers immediately or as soon as possible after use. The containers shall be labeled or color-coded, leak and puncture proof, closable, and easily accessible to the user. They shall be located as close as feasible to the immediate area where sharps are used or can be reasonably anticipated to be found (e.g., laundries) and in such an area as to prevent tampering by unauthorized individuals. A standard 42-inch mounting height as measured from the floor shall be followed.
Sharps containers shall be maintained upright throughout use and not allowed to over-fill. Sharps containers shall be disposed of after they become three-fourths full by following the facility disposal guidelines. Contact your facility manager for the pick-up and disposal process of potentially infectious waste materials.
During replacement or removal from the work area, the sharps containers shall be closed to prevent the spillage or protrusion of contents during handling, storage, transport, or shipping. The sharps containers shall be placed into a secondary container if leakage is possible. The second container shall be closable, constructed to contain all contents and prevent leakage during handling, storage, transport or shipping, be red in color, and labeled with the biohazard symbol or the words “Infectious Waste”.
Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury.
Hepatitis B Vaccination
Employees who have the potential for occupational exposure shall be provided, at no cost, the hepatitis B vaccine and vaccination series along with the following information:
- Efficacy of the vaccine;
- Safety of the vaccine;
- Method of administration;
- Benefits associated with vaccination; and
- Acknowledgement of free vaccine and vaccination.
A hepatitis B prescreening program shall not be a prerequisite for receiving the vaccination.
An employee who initially declines the hepatitis B vaccination shall be allowed to receive the vaccination at a later date if the employee decides to seek the vaccination series. Employees who decline to accept the vaccination shall be required to sign the Hepatitis B Vaccine Acceptance or Declination.
If a routine booster dose(s) of the hepatitis B vaccine is recommended by the U.S. Public Health Service at a future date, such booster dose(s) shall be made available.
Post Exposure Evaluation Follow-up
All exposure incidents with blood or OPIM shall be reported in accordance with the Accident/Incident Reporting and Investigation Program.
Immediately following an exposure incident, a confidential medical evaluation and follow-up shall be provided at no cost to the employee. This medical evaluation shall include at least the following elements:
- Documentation of the route(s) of exposure and the circumstances under which the exposure incident occurred;
- Identification and documentation of the source individual, unless the employer can establish that identification is infeasible or prohibited by the state or local law;
- The source individual’s blood shall be tested as soon as feasible and after consent is obtained in order to determine hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infectivity. ** If consent is not obtained, the employer shall establish that legally required consent cannot be obtained. When the source individual’s consent is not required by law, the source individual’s blood, if available, shall be tested and the results documented.
- When the source individual is already known to be infected with HBV or HIV, testing for the source individual’s known HBV or HIV status need not be repeated.
- Results of the source individual’s testing shall be made available to the exposed employee, and the employee shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual.
- Collection and testing of blood for HBV and HIV serological status;
- The exposed employee’s blood shall be collected as soon as feasible and tested after consent is obtained.
- 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 at least 90 days. If within 90 days of the exposure incident, the employee elects to have the baseline sample tested, such testing shall be done as soon as feasible.
- Post-exposure prophylaxis, when medically indicated, as recommended by the U.S. Public Health Service;
- Counseling; and
- Evaluation of reported illnesses.
Information Provided to the Healthcare Professional
Environmental Health and Safety shall provide the healthcare professional responsible for the employee’s hepatitis B vaccination (University of Chicago’s Occupational Medicine Group – UCOM) a copy of the regulation.
The employer shall ensure that the healthcare professional evaluating an employee after an exposure incident is provided the following information:
- A copy of the regulation;
- A description of the exposed employee’s duties as they relate to the exposure incident;
- Documentation of the route(s) of exposure and circumstances under which exposure occurred;
- Results of the source individual’s blood testing, if available; and
- All medical records relevant to the appropriate treatment of the employee including vaccination status.
The employer shall obtain and provide to the exposed employee a copy of the healthcare professional’s written opinion, within 15 days of the completion of the evaluation.
The healthcare professional’s written opinion for Hepatitis B vaccination shall be limited to whether Hepatitis B vaccination is indicated for an employee, and if the employee has received such vaccination.
The healthcare professional’s written opinion for the post-exposure evaluation and follow-up shall be limited to the following information:
- That the employee has been informed of the results of the evaluation; and
- That the employee has been told about any medical conditions resulting from exposure to blood or OPIM which require further evaluation or treatment.
- All other findings or diagnosis shall remain confidential and shall not be included in the written report. Medical records shall not be disclosed or reported without the employee’s express written consent to any person within or outside the workplace except as required by law.
Labels and Signs
Warning labels including the biohazard symbol shall be affixed to containers of regulated waste, refrigerators, and freezers containing blood or OPIM, and other containers used to store, transport, or ship blood or other potentially infectious materials. A warning label or sign shall be posted at the entrance to work areas where blood or OPIM are stored.
These labels shall be fluorescent orange, orange-red, or predominantly visible with lettering or symbols in a contrasting color.
Containers or bags used for blood or OPIM shall be red in color and labeled with the Biohazard Symbol or the words “Infectious Waste”.
Labels shall be affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal.
Red bags or red containers may be substituted for labels.
The employer shall post signs at the entrance to work areas of HIV and HBV research laboratory and production facilities. The sign shall contain the name of the infectious agent, special entrance requirements, and the name and telephone number of the responsible person.
Training and Information
All employees with the potential for occupational exposure to blood or OPIM shall be trained during working hours prior to initial assignment to a task involving the potential for occupational exposure and annually thereafter. This training shall utilize the “Bloodborne Pathogens” training booklet generated by Environmental Health and Safety. All presenters shall be knowledgeable in the subject material as it relates to the workplace and provide an opportunity for questions and answers during the training. Department specific training can be conducted utilizing Departmental Infection Control Procedures and/or laboratory protocols.
This comprehensive training program includes the following:
- A copy of the Bloodborne Pathogen regulation;
- Epidemiology and symptoms of bloodborne diseases;
- Modes of bloodborne pathogens;
- A copy of the written Exposure Control Plan and explanation of the program;
- Methods for recognizing tasks and other activities which may involve exposure to blood or OPIM;
- Methods of utilizing existing engineering controls, work practices and personal protective equipment;
- Information on the types, proper use, location, removal, handling, decontamination, and disposal of personal protective equipment, including basis for selection;
- Information on the hepatitis B vaccine including the efficacy of the vaccine, safety of the vaccine, method of administration, benefits associated with vaccination, and acknowledgement of the option to decline or accept the free vaccination series;
- Emergency procedures and notifications involving blood or OPIM;
- Incident reporting documentation and follow-up procedures;
- Post-exposure and follow-up evaluation subsequent to an exposure incident; and
- Explanation of signs and labels and/or color-coding system required.
All employees attending training shall be required to demonstrate adequate knowledge retention as shown through a learning measurement exercise. Employees not demonstrating adequate knowledge retention shall be retrained and retake the exercise until adequate retention is demonstrated. The passing criteria for the learning measurement exercise is 70 percent.
Training records shall be maintained by Environmental Health and Safety for three years subsequent to the initial training period. Training records shall include:
- Dates of the training sessions;
- Contents or summary of the training sessions;
- Names and qualifications of persons conducting the training;
- Names and job titles of all persons attending the training sessions; and
- Results of learning measurement exercise.
An accurate medical record shall be maintained by UCOM on each employee with occupational exposure. This record shall include the following:
- Name and social security number;
- Hepatitis B vaccination status and dates;
- Copies and results of examinations, medical testing, and follow-up procedures; and
- Copies of The University of Chicago Hepatitis B Vaccine Acceptance or Declination.
All medical records shall be kept confidential in accordance with HIPPA (Health Insurance Portability and Accountability Act) regulations and not disclosed or reported without the employee’s express written consent to any person within or outside the workplace.
All records shall be maintained for the duration of employment and 30 years thereafter.
Sharps Injury Log
A sharps injury log shall be maintained by Human Resources for the recording of percutaneous injuries from contaminated sharps. The information shall be recorded and maintained in such a 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; and
- An explanation of how the incident occurred.
Safer Medical Devices
Safer sharps devices must be evaluated and documented to prevent or minimize exposures to Bloodborne Pathogens. This evaluation must also consider whether these devices could prevent future workplace exposures. Safer devices are implemented assuming that they are appropriate, commercially available, and effective. Please see the list of sharps safety devices available.
The employer must 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 controls, including safer medical devices. Applicable employees may fill out the Employee Recommendation for Safety Products Form.
Exposure Control Plan Review
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 reflect new or revised employee positions with occupational exposure. The review and update shall also:
- Reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens;
- Annually document consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure; and
- 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.
Reviewed: June 2017