Georgetown University Medical Center

Safety Policy

BLOODBORNE PATHOGENS, 29 CFR 1910.1030

Exposure Control Plan

I. POLICY

The Occupational Safety and Health Administration (OSHA) has mandated that all employers develop and implement an Exposure Control Plan as outlined in OSHA's Bloodborne Pathogen standard. It is the policy of Georgetown University Medical Center (GUMC) to identify job categories that have a reasonably anticipated risk of occupational exposure to bloodborne pathogens and other potentially infectious blood and body fluids, to abate all potential hazard, and to provide training and education for those employees who may be exposed during the performance of their duties. GUMC will fully comply with the standard's requirements as part of its continuing commitment to the health and safety of all employees.

II. DEFINITIONS

A. Bloodborne Pathogens - pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV).

B. Occupational exposure - reasonably anticipated skin, eye, mucous membrane, non-intact skin, or parenteral contact with blood and other potentially infectious materials that may result from the performance of an employee's duties.

C. Other potentially infectious materials - 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, all body fluids in situations where it is difficult or impossible to differentiate between the fluids, and any unfixed tissue or organ (other than intact skin) from a human (living or dead).

D. Standard Precautions - All human blood or body fluid is to be considered potentially infectious. Appropriate personal protective equipment and engineering controls will be utilized for any procedure in which direct contact with human blood or body fluid is possible.

III. RESPONSIBILITIES

A. Office of Dean of Research

1. Establish a policy that ensures compliance with OSHA's (29) Code of Federal Regulations, Part 1910, Section 1030.

2. Ensure that adequate resource allocation mechanisms are in place to support the program requirements.

3. Ensure continued compliance through monitoring and audit programs.

B. Institutional Biological and Chemical Safety Committee (IBCSC)

1. Provide policy guidelines in the implementation of the Bloodborne Pathogen safety program.

2. Advise and make recommendations to the Dean of Research regarding compliance requirements.

C. Office of Environmental Health and Safety

1. Develop and implement this policy.

2. Provide guidelines to affected departments in the development of specific safety programs required by the OSHA law and this policy.

3. Conduct required surveys to maintain program compliance.

4. Initiate revision of this plan whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure, and to reflect new or revised employee job classifications or positions with occupational exposure.

5. Provide notification and information to main campus and medical center personnel regarding general session Bloodborne Pathogen training. Assist Employee Health in annual training program.

6. Provide support personnel for the collection and disposal of sharps containers, biohazardous waste, and infectious waste for Medical Center locations.

D. Department/ Supervisors

1. Follow all Exposure Control Plan policies and protocols for the various departmental tasks and job classifications listed in Section II, A, 1.

2. Ensure that employees are trained and educated on the hazards posed by bloodborne pathogens and equip them with the skills necessary to deal with potential bloodborne hazards.

3. Provide funding for appropriate safety equipment, protective clothing and Hepatitis B vaccination.

4. Ensure that proper signage and labels are in place at the sites, and on equipment where human blood, blood products, and other potentially infectious materials are used or stored.

5. Ensure that laboratory personnel are trained in waste decontamination procedures (e.g. autoclaving/ incineration).

6. Ensure that personnel whose duties have changed from non-exposure to potential exposure to blood and blood products are included in this policy.

E. Hospital Department of Infection Control

1. Provide annual Bloodborne Pathogen training in conjunction with Employee Health Services. Training is to be accomplished through general sessions offered twice yearly.

2. Provide technical assistance on matters regarding bloodborne pathogens and infection controls.

F. Employee Health Service

1. Administration of the Hepatitis B vaccination program.

2. Provide annual Bloodborne Pathogen training in conjunction with the Department of Infection Control.

3. Provide the necessary occupational medical surveillance and counseling for employees who may have been exposed to bloodborne pathogens.

G. Hospital Facility Services

1. Provide support personnel for the collection and disposal of sharps containers, biohazardous waste, and infectious waste for Hospital locations.

H. Employees

1. Follow the safety provisions outlined in the Bloodborne Pathogen Exposure Control Plan developed for their operations, tasks, or procedures. Utilize "Standard Precautions".

2. Provide suggestions to the department head or supervisor, for safety improvements to the existing Exposure Control Plan.

3. Report accidents involving human blood products, body fluids, and other potentially infectious materials to the supervisor and obtain medical attention at the Employee Health Services.

4. Attend mandated safety training.

II. PROCEDURE:

A. Exposure Determination List

1. A list of those employees that may be at risk for occupational exposure as defined (above) by the Occupational Safety and Health Administration (OSHA) standard is based on risks incurred without regard to the use of personal protective equipment.

Note: Exposure of personnel will vary according to assigned job duties, and must be assessed individually.

Job Title

Animal Resource Facility Manager

Assistant/ Head/ Basketball Athletic Trainer

Autopsy Assistant I/II

Chairman

Clinical Labs Administrator

Clinical Operations Manager

Clinical Research Specialist

Health Physicist/ Radiation Safety

Instructor

Laboratory Assistant I/II

Laboratory Technician/ Technologist I/II/III

Lab Supervisor/ Manager

Lab Services Manager/ Technician

Medical Center Fellow, MD

Medical Center Fellow, Ph.D.

Occupational Safety Staff

Post Doctoral Fellow

Principal Investigator

Professor

Professor, Adjunct

Professor, Assistant

Professor, Associate

Professor, Research

Professor, Research Assistant

Professor, Visiting Assistant

Research Assistant I/II/III/IV

Research Associate

Special Research Assistant II/III/IV

Veterinarian

Veterinarian Assistant

Veterinary Technician

2. In performing the following procedures/ tasks, occupational exposures can occur:

• Handling contaminated sharps, and other laboratory devices
• Surgical procedures
• Handling of animals (and all associated equipment, bedding, etc.) infected with human bloodborne pathogens
• Pathology procedures involving contact with tissue and other body substances including post mortem exam
• Procedures involving the containment and management of "regulated waste" disposal
• All procedures involving contact with cerebral spinal fluid, mucous membranes, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, blood and all other body substances

Further identifications of specific tasks where occupational exposure can occur are found in individual departments' or laboratories' policies and procedures.

B. Work Practice and Engineering Controls

The following Work Practice Controls are in place at Georgetown University Medical Center. Procedures further defining controls are found relevant to a specific department or laboratory.

1. Hand washing is required, and is accomplished at hand washing facilities that are readily accessible to employees.

a. Hands are washed immediately or as soon as feasible after removal of gloves or other personal protective equipment.

b. Antiseptic towelettes are supplied when hand washing facilities are not readily available. When towelettes are used, hands are washed with soap and running water as soon as possible.

2. Sharps disposal - Efforts to eliminate or minimize the risk of occupational exposure to sharp devices, e.g., scalpels, needles, etc., are reviewed and evaluated on an ongoing basis by the Biological and Chemical Safety Committee and the Office of Environmental Health and Safety at GU Medical Center.

a. Needles are not recapped by hand. If needles must be recapped, the procedure is accomplished using a one-handed technique.

b. Contaminated needles are not bent, sheared or broken before disposal.

c. All contaminated sharps are disposed of in puncture-resistant, leak-proof containers, and are labeled with the biohazard symbol, or are color-coded red.

d. Sharps containers are easily accessible to personnel and are located in areas convenient to where sharps are used.

e. Sharps containers are routinely inspected and replaced as indicated when contents are found to be inadequately contained.

f. Sharps containers are discarded with the infectious waste stream when 3/4 full or less.

g. Safe practices are used when handling or reprocessing reusable sharps.

3. General Regulation and Hazard Abatement Measures

a. Mechanical pipettes are required where appropriate and are available for use where necessary. Mouth pipetting is prohibited.

b. Eating, drinking, applying cosmetics and handling contact lenses is prohibited in work areas where there is potential of occupational exposure.

c. Storage of food and drink is prohibited in places where potentially infectious materials are kept.

d. All specimens of blood or other potentially infectious materials are contained in leak-proof containers during handling, processing, storage, transport or shipping. Specimens are not left uncovered on counter tops. All specimens are handled using standard precautions.

e. Equipment that may become contaminated is inspected for blood or other potentially infectious materials regularly and decontaminated as necessary.

f. All activities involving other potentially infectious materials are conducted in biological safety cabinets or other physical-containment devices within the containment module. No work with these other potentially infectious materials shall be conducted on the open bench.

C. Personal Protective Equipment

1. All departments where occupational exposures occur have previously identified and defined barriers to be worn for tasks involving blood and body fluid (including sharps) contact. Please see individual department and/or division universal precautions policies.

a. PPE is considered "appropriate" by OSHA only if it does not permit "blood or other potentially infectious materials to pass through 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 that the protective equipment will be used."

b. PPE is supplied and is readily available, or issued to the employee, in all areas where occupational exposure can occur.

c. PPE includes, but is not limited to, gloves, gowns, laboratory coats, face shields and/or masks, eye protection, and others.

d. Gloves are worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and non-intact skin; when performing vascular access procedures and/or when handling or touching contaminated items or surfaces. Disposable (single-use) gloves are removed as soon as is practical when contaminated, or as soon as feasible if they are torn, punctured, or when their ability to function as a barrier is compromised. Disposable gloves are not washed or reused. Hypo-allergenic gloves, glove liners, powderless gloves, or other similar alternatives are readily accessible to those employees who are allergic to the gloves normally provided.

e. Masks in combination with eye protection devices such as goggles or glasses with solid side shields, or chin-length face shields are worn whenever splashes, spray or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated.

f. Gowns and other protective clothing such as aprons or lab coats, or similar outer garments are worn in occupational exposure situations. Type and characteristics of protective clothing will depend upon the task and the degree of anticipated exposure.

g. Surgical caps or hoods, or shoe covers or boots, are worn in instances when gross contamination can reasonably be anticipated, e.g., animal surgeries, etc.

h. When a protective garment(s) is penetrated by blood, or other potentially infectious materials and the substance has reached the employee's own work clothes, street clothes, or undergarments, the clothing is removed immediately, or as soon as is possible prior to the employee leaving the work area.

The Hospital laundry service launders personal clothing penetrated by blood or other potentially infectious materials at no cost to the employee. Soiled clothing must be placed into a non-red plastic bag. The employee or supervisor then notifies the Hospital Materials Management Administration, who is responsible for retrieval and return of the clothing. Additional procedures relevant to handling contaminated personal clothing are written specifically for individual departments or laboratories.

D. Spills and Waste

1. Remediation of spilled potentially infectious materials is the responsibility of the person/ lab causing the spill. Only trained personnel will remediate spilled biohazardous material . Upon spilling a potentially infectious agent, human blood or body parts, etc., the area must be isolated and others warned to stay away until further notice. University Security can assist in isolating an area (controlling pedestrian traffic) if necessary, but may not assist in the actual remediation. Whenever possible, a 10:1 water to bleach solution will be used to decontaminate surfaces or equipment. Liquids may be decontaminated with a 10:1 solution of liquid to bleach. All potentially contaminated materials that may not be decontaminated with bleach, or are used in the decontamination process, must be autoclaved or discarded in a red, biohazardous waste bag.

2. Broken glassware that may be contaminated is not picked up directly with the hands. It is cleaned up using mechanical means, such as a brush and dustpan, tongs, or forceps, according to established procedures.

3. All bins, pails, cans, and similar receptacles intended for reuse that have a reasonable likelihood for becoming contaminated with blood or other potentially infectious materials are inspected and decontaminated on a regularly scheduled basis, according to established procedure.

4. OSHA-defined regulated waste is handled and managed in accordance with the Hospital Policy, "Guidelines for Infectious Waste Management." Disposal of all regulated waste is done according to applicable regulations of the District of Columbia and other jurisdictions.

E. Biohazard Communication

1. Warning labels are affixed to containers of regulated waste, refrigerators and freezers and other containers, surfaces, and materials used to store, transport, work with, or ship blood or other potentially infectious materials.

a. Label Required:

Label Color:

Fluorescent orange or orange-red with lettering or symbols in a contrasting color.

b. Biohazard signs are posted at the entrance to labs using potentially infectious materials and must include the name of the potentially infectious agent and an emergency phone number for the laboratory director or other responsible person.

c. Red bags or red containers are, on occasion, substituted for biohazard labels at the GU Medical Center.

F. Equipment

All equipment leaving the laboratory for purposes of repair, relocation, loan, or sale must be decontaminated before leaving the laboratory. Decontamination must be accomplished by an approved method and documented. Any part of equipment that can not be decontaminated due to structure, sensitivity, integrity, etc. must be labeled as biohazardous in accordance with the OSHA Bloodborne Pathogens regulation and the receiving party informed in writing of the potential hazard.

G. Information and Training

1. Georgetown University Medical Center ensures that all employees with occupational exposure participate in training programs, at no cost to the employee, and during working hours.

a. Training is provided at the time of initial assignment of an employee to job titles/ tasks where occupational exposure may take place.

b. Training is provided at least once every 365 days.

c. Additional training is provided when changes such as modification of tasks or procedures, or institution of new tasks or procedures affect the employee's occupational exposure.

III. IMMUNIZATIONS

A. Availability

Hepatitis B vaccination is available after the employee has received training required by the OSHA regulation and within 10 working days of initial assignment to all employees who have occupational exposure unless the employee has previously received the complete hepatitis B vaccination series, antibody testing has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons. Employee Health Services will provide the immunizations at no cost to the employee. However, the fees for the immunizations will be paid by the respective department.

B. Declining the Vaccination

Employees declining the hepatitis B vaccination must sign the declination form found in Appendix A. If the employee initially declines hepatitis B vaccination, but at a later date, while still covered under the standard, decides to accept the vaccination, the vaccination shall be available.

IV. HIV AND HBV RESEARCH LABORATORIES

A. Procedures

Principal Investigators wishing to use HIV or HBV in research must comply with numerous GU and Federal requirements.

1. All research involving potentially infectious materials must first be approved by the Institutional Biological and Chemical Safety Committee. This committee grants or denies approval for use of potentially infectious materials in research based upon National Institutes of Health (NIH) and Centers for Disease Control (CDC) guidelines found in, "Biosafety in Microbiological and Biomedical Laboratories."

2. All proposed work must be in compliance with the OSHA Bloodborne Pathogens regulation and this policy.

3. The Office of Environmental Health and Safety conducts periodic inspections of these laboratories to ensure safe work practices and compliance with applicable regulations and guidelines.

V. PROCEDURE FOR EVALUATION OF EXPOSURE INCIDENTS

A. Action

In the event an employee sustains an occupational exposure to blood or other body fluids, the employee must notify his/her immediate supervisor, and report without delay to the Employee Health Service. In the event that the Employee Health Service is closed, the employee will report the next business day.

1. If the employee has not been immunized with the hepatitis B vaccine, or has not completed the immunization series, and the exposure is from a known hepatitis B positive source, the employee reports to the Employee Health Service within 24 hours. In the event the Employee Health Service is closed, the employee proceeds within 24 hours of exposure to the emergency department.

2. If the exposure is from a known HIV positive source, and the Employee Health Service is closed, the employee proceeds immediately to the Emergency Department for necessary follow up. The E.R. will send the report to the Employee Health Service on the first working day following the E. R. visit.

B. Treatment

The Employee Health Service follows the OSHA Bloodborne Pathogens regulation, the Center for Disease Control (CDC,) and the Hospital Infection Control Committee approved protocol 35 for blood and body fluid exposure.

C. Records

The Employee Health Service maintains records and documentation of all reported blood and body fluid exposure incidents. These records are confidential and are kept on file for the duration of employment plus 30 years.

D. Report to Counsel

Additionally, the employee must complete a Report to Counsel that describes the accident, injuries sustained, affect on others, and controls to be implemented in order to prevent the accident from recurring.

VI. PLAN REVIEW

This Policy/ Plan is reviewed on an annual basis by the Office of Environmental Health and Safety.

Revision of this plan will occur whenever necessary to reflect new or modified tasks and procedures that affect occupational exposure, and to reflect new or revised employee positions with occupational exposure.

Reviewed/ Revised: Date:

Reviewed/ Revised: Date:

APPENDIX A

DECLINATION FORM

HEPATITIS B VACCINATION

DECLINATION FORM

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 myself. 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:

(Print Name):

Date Signed:

APPENDIX B

OSHA BLOODBORNE PATHOGENS REGULATION

29 CFR 1910.1030