Environmental Health and Safety
Bloodborne Pathogens Program
HEPATITIS B VACCINE FORM Completion Required by WA State Bloodborne Pathogens Regulation, WAC-296-823
Please print clearly or type Name (Last, First, Mi):
Birthdate (XX/XX/XXXX):
Job Title:
Employee ID Number:
Select one: UW Employee UW Employed Student Non-UW Employed Student. If selected provide, Student ID Number:
Email:
Daytime Phone (Required):
Department:
Box Number:
UW Work Location: Seattle Campus Harborview South Lake Union Other specify: Supervisor/PI Name:
Complete and sign one of the sections below
I.
I WOULD LIKE TO RECEIVE THE HEPATITIS B VACCINE
I would like to receive or complete the three dose hepatitis B vaccine series and titer. Please contact me at the above phone number to schedule. Comments:
Employee Signature: Date: II. I DECLINE THE HEPATITIS B VACCINE BECAUSE I HAVE ALREADY HAD IT To the best of my knowledge, I completed the hepatitis B vaccine. The dates of my hepatitis B immunizations are below. Please fax official hepatitis B immunization record to the UW Employee Health Center at 206-221-5110. Vaccine Series received at UW Yes No
Dose 1 Date:
Dose 2 Date:
Dose 3 Date:
Titer Results and Date:
Comments:
Employee Signature: III. I DECLINE THE HEPATITIS B VACCINE
Date:
This ‘Declination Statement’ for the hepatitis B vaccine is provided in accordance with the Washington State Department of Labor and Industries Regulation on Bloodborne Pathogens (WAC 296-823). The link to this regulation is below: http://www.lni.wa.gov/wisha/Rules/bbpathogens/default.htm "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.” I have read and understand the above statement and I am declining the hepatitis B vaccine.
Employee Signature:
Date:
For questions about the hepatitis B vaccine or this form, call the UW Employee Health Center at 206-685-1026
Submit this completed Hepatitis B Vaccine Form to UW Employee Health Center, Hall Health Center, Box 354410, fax 206-221-5110 EH&S Research & Biological Safety Office (RBSO), 206.221.7770,
[email protected]
Rev: 04/11
UW Bloodborne Pathogens for Researchers Training
7 minutes - fill out Forms
Welcome BBP Attendees!
Registration
Please Pick up Handouts 1. Registration Form 2. Copy of Slides
Hepatitis
3. Hepatitis B Vaccination Form 4. Hepatitis B Vaccine Information Sheet
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Washington Administrative Code (WAC) 296-823
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All UW employees with a reasonably anticipated potential for exposure to human source materials, including human blood and its
are required to comply with the UW BBP Program.
Reduce risk of BBP exposure to workers Annual Training required EH&S
Requirements for HIV/HCV/HBV labs Resources
components, human tissue, all human cell lines, as well as medications derived from blood (e.g., immune globulins, albumin) and other potentially infectious materials (OPIM),
(Needlestick Safety and Prevention Act)
About the Bloodborne Pathogens Program About Bloodborne Pathogens (BBP) Exposure Control What to do if you have an exposure
EH&S
– Enacted in 1993 – Safe sharps requirements in 2000
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UW BBP Program
Bloodborne Pathogen (BBP) Rule
UW Bloodborne Pathogen Training
Overview
Judy Cashman, RN EH&S Research & Occupational Safety 206-221-7770,
[email protected] [email protected]
EH&S
Need to fill out both forms and hand in at end of class
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Bloodborne Pathogens Training for Researchers
B Vaccination
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Principal investigators (PIs)/supervisors are responsible for assessing activities in the workplace and determining if employees have a potential for occupational exposure. Requirements of the UW BBP Program: – Developing a BBP Exposure Control Plan – Offering the hepatitis B vaccine – Training
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Roles & Responsibilities
BBP Statistics
In Washington, Labor & Industries (L&I) estimates ~44,000 needlestick injuries per year
By Dec, 31, 2000, CDC reports: 57 health care workers have seroconverted following occupational exposure to HIV – 25 have developed AIDS – 3 were lab workers working with concentrated virus – Percutaneous exposure was the most common route EH&S
UW Bloodborne Pathogen Training
– Administer the UW BBP Program – Assist in obtaining the Hepatitis B Vaccine – Provide BBP Training – Issue Biological Use Authorization to labs – Consultation and Incident/accident follow-up investigation
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Roles & Responsibilities
EH&S
– ID hazards and who needs to be in the BBP Program
– Ask questions – Suggest safer work practices/ procedures to your PI
– Provide lab specific safety training – Enforce safety rules
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How are Suggestions or changes to work practices communicated?
2. 3. 4. 5.
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Roles & Responsibilities
staff meetings email 1:1 suggestion box/other Don’t know/not sure
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Staff (You) – Wear required PPE
– Provide personal protective equipment
1.
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– Follow the exposure control plan
– Develop/review lab Exposure Control Plan
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Roles & Responsibilities
Principal Investigator
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Employee Health Center – Provide clinical services – Administer hepatitis B vaccine – Provide Post-exposure counseling
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Bloodborne Pathogens Microorganisms that are present in human blood and its components and can cause disease.
Human Immunodeficiency Virus (HIV) - AIDS Hepatitis B virus (HBV) – Hepatitis B Hepatitis C virus (HCV) – Hepatitis C Brucella spp. (bacterium) – Brucellosis
Babesia (parasite) - Babesiosis Treponema pallidum- Syphilis Arboviruses- Viral hemorrhagic fever, West Nile Virus Prions- Creutzfeld-Jakob Disease Plasmodium spp. - Malaria
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Blood, organs or tissues from animals infected w/ HIV/HBV/HCV Human cell lines including established Unfixed tissues or organs, Semen, Cerebrospinal Fluid, Peritoneal Fluid, Pericardial Fluid, Amniotic Fluid, Synovial fluid, Vaginal Secretions
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Where will I go if I have a question about “OPIM”?
…unless you can SEE the blood in them…but still handle with caution. – Urine – Feces – Vomit – Sweat – Tears – Saliva EH&S
HIV/HBV/HCV containing cultures (cell, tissue, or organ), and solutions
-Any body fluid contaminated with blood or OPIM
Not Risk for BBP transmission
Other Potentially Infectious Materials (OPIM)
Check the Washington Administrative Code (WAC) 296-823 See the EH&S website: www.ehs.washington.edu/ Call Research and Occupational Safety: 206-221-7770 Check the lab Biosafety Manual
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Transmission of BBP
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BBP-Occupational Exposure
Occupational Exposure
Reasonably anticipated skin, eye, mucous membrane, or parenteral (piercing of the skin) contact with blood or OPIM that may result from the performance of an employee's duties
Skin – Needle sticks or contaminated sharps injuries – Open wound contamination: cut, rash, dermatitis, psoriasis
Exposure Incident is a specific contact with blood or OPIM that is capable of transmitting a bloodborne disease EH&S
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Mucous membrane exposure: eyes,
nose, mouth
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Transmission Risk of BBP Risk of infection depends on several factors:
Transmission Risk following Exposure to Infected Blood Virus
Pathogen involved Type/route of exposure
# of virus particles/ml of blood 6
Hepatitis B
Amount of virus in infected
(Millions – trillions)
blood during exposure Amount of infected blood
Hepatitis C
involved in the exposure
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was taken
HIV (AIDS)
Specific immune response of UW Bloodborne Pathogen Training
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Hepatitis B
(45-180 days)
30-50% of infected develop clinical illness 0.5-1% of infected develop rapid fatal liver disease 2-10% of infected develop chronic active hepatitis-carrier state, infectious for life. Very stable-persists at room temp for 7days.
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1 in 300 (0.3%) 20
Most common chronic bloodborne infection 80% infected without symptoms (CDC) Incubation period 2 weeks-6 months ~16 hrs-4 days on surfaces No vaccine EH&S
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Human Immunodeficiency Virus (HIV)
jaundice fatigue loss of appetite nausea abdominal discomfort dark urine clay-colored stool
Normal eyes
Fragile – lives only a few hours outside the body Causes Acquired Immunodeficiency Syndrome (AIDS) AIDS allows development of opportunistic disease, which ultimately causes death. A flu-like illness can occur 1-6 weeks after exposure to the virus: -Fever, sweats, malaise, muscle pains, nausea, diarrhea,
Jaundiced eyes EH&S
1 in 30 (3%)
Source: Centers for Disease Control and Prevention
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Hepatitis B and C Symptoms
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1 in 3 (30%)
Hepatitis C
Statistically the greatest risk 6-30% risk following exposure incident (non-immunized) Incubation period is 6 weeks- 6 months
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10-10
(Tens – thousands)
infected individual EH&S
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(Millions)
If post-exposure treatment
Courtesy of Owen Mumford, Inc.
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10 -10
Risk of infection
following parenteral (needlestick or cut) exposure
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Enlarged lymph nodes, mycological oral infections, fatigue, weight loss Symptom-free period of 5-10 years can occur EH&S
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What is the most common route of exposure to BBP in the workplace?
Exposure Control Plan (ECP)
1.
Injury from contaminated needlesticks and/or sharps
2.
Eye and mucous membrane exposure
3.
Open wound contamination (cut, dermatitis, psoriasis)
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Exposure Control Plan 1.
Exposure Determination
2.
Method of Compliance or implementation
3.
Hepatitis B vaccination, PostExposure evaluation and follow-up
4.
Communication of Hazards to employees
5.
Record keeping EH&S
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Engineering controls
Work practices
Personal Protective Equipment
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Biosafety Manual contains UW Core ECP, in Section IX See online at-
http://www.ehs.washington.edu/r bsbiosafe/bsmanualindex.shtm UW Bloodborne Pathogen Training
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1. Exposure
Determination:
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By job classification By tasks and procedures Without consideration of PPE worn EH&S
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ECP- Universal Precautions
2. Control Employee Exposure: Universal precautions
http://www.lni.wa.gov/wisha/Rule s/bbpathogens/default.htm
Exposure Control Plan
Exposure Control Plan
Must include BBP standard-
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EH&S
Blood and OPIM ALWAYS considered infectious Appropriate barriers and procedures must be used when contact with blood or OPIM is anticipated
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Safe BSC Use Video:
ECP-Engineering Controls
Proper Use of a Biological Safety Cabinet (SD – 2002) An excellent review of safe BSC work practices covering preplanning, PPE, cabinet preparation, work practices, spills, and post process steps.
TOOLS to Prevent Exposure
NOTE! There are three differences for BSC work at the UW. Important: Sharps are not prohibited in BSCs at the UW. Water can be used after the decontaminating bleach and is recommended by Baker for their BSCs. Good hand washing is more about sudsing soap and scrubbing for at least 20 seconds than the use of germicidal soap.
Biological Safety Cabinet (BSC) EH&S
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Centrifuge Safety Features
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Safer Medical Devices – Needleless systems
– Receive training – Safety cups/buckets or O-ring – When in Biosafety Cabinet (BSC) place at rear, don’t perform other work while running – Wait 5 minutes to unload – Stop immediately for unusual vibration or noise and notify supervisor – Ensure proper balancing – Do not overfill EH&S
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ECP-Engineering Controls
ECP-Engineering Controls
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– Sharps with engineered sharps injury protections (SESIP)
Unprotected position Protected position
– Self-blunting needles – Plastic capillary tubes – Exemptions for safer needle requirements, if not using these 33
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Example of needle guard with protected sliding sheath that is pushed forward after use and locks (with some designs the shield must be twisted to engage the lock).
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Sharps Containers with Problems
ECP-Engineering Controls Sharps disposal containers -
Closable Puncture-resistant Leak-proof Labeled or color-coded Upright, conveniently placed in area where sharps used - DO NOT OVERFILL!
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ECP-Work Practice Controls
ECP-Work Practice Controls
Key Concept Perform all tasks in a manner that reduces spraying, splashing or aerosolization. EH&S
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Handle sharps safely to minimize exposure to blood or OPIM: Don’t recap or remove needles Don’t bend, shear or break needles Place contaminated reusable sharps immediately in appropriate containers until properly decontaminated EH&S
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More Tips on Safe Sharps Handling
Know what Sharps include: http://www.ehs.washington.edu/rbsresplan/sharp.shtm (needles, IV tubing with needles attached, scalpel blades, lancets, syringes that have been removed from their original sterile containers, and glass tubes that could be broken during handling)
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ECP-Work Practice Controls
Develop and implement specific policies for safe handling: http://safeneedle.org/us-needlesticks/preventingneedlestick-injuries-a-checklist/ Do not handle broken glassware directly by hand
9/13/2012
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ECP-Work Practice Controls
Hand washing No food/cosmetics No mouth pipetting Dispose of gloves after use
Remove gloves safely and properly – Grasp near cuff of glove and turn it inside out. Hold in the gloved hand. – Place fingers of bare hand inside cuff of gloved hand and also turn inside out and over the first glove. – Dispose gloves into proper waste container
DEMO of GLOVE REMOVAL: https://depts.washington.edu/ehas/pubcookie/train/bbpx/bbp6a.php EH&S
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ECP- Work Practice Controls
ECP-Work Practice Controls
Written cleaning and decontamination schedule and procedures Decontamination Agents:
1.
– Bleach 1:10 – EPA certified agent (alcohol is not) – Quaternary Compounds – Premixed: Environcide clavicide
2.
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ECP-Work Practice Controls Regulated Waste
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ECP- Signs and Labels
Place in second container if leaking possible or if outside contamination of primary container occurs Contaminated equipment must have biohazard sign attachedinform supervisor
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– Plastic ziplock, or styrofoam
– Consider where the sample will travel (the end user)
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– If clothing becomes contaminated, immediately remove it. – Must be removed prior to leaving the work area. PPE must not be worn in common areas.
More information on EH&S website http://www.ehs.washington.edu/rbsbiosafe/appendixb.pdf
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– Must not permit blood or OPIM to pass through or reach outer or inner clothing, mucous membranes or skin.
If in a Biohazard container or other designated container, don’t need label
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Type and amount of PPE required depends on the task and anticipated exposure.
Put in secondary leakproof container
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http://www.ehs.washington.edu/rbsbiosafe/postbz.shtm
ECP-Personal Protective Equipment (PPE)
Precautions required when transporting blood
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Close immediately before removing or replacing
BIOHAZARDOUS WASTE, incl. Flow Charts http://www.ehs.washington.edu/ohsreslab/biowaste.shtm
Place absorbent material atop spill, sufficiently spray/cover entire area. Some start at the edges and work in, others just cover the area. You want to ensure that you cover the contaminated area.
SPILLS VIDEO: https://depts.washington.edu/ehas/pubcookie /train/bbpx/bbp7.php
Contact time is critical EH&S
Decontamination
– Provided at no cost to employee. 47
Nitrile gloves for alcohol. EH&S
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ECP-Medical Management
ECP-Laundry For Contaminated articles:
3. Medical Management
– Handle as little as possible
Bag/contain where used
a. Hepatitis B vaccine
Don’t sort or rinse where used
b. Post exposure
Place in leak-proof, labeled or color-coded containers or bags
evaluation
c. Follow-up
– Wear PPE when handling and/or sorting
Gloves
Gown EH&S
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ECP- Medical Management
EH&S
Must be offered within 10 days of initial assignment
3 injections at 0, 1, 6 months
Check titer 1-2 months after series
96-99% effective
No boosters needed
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Hepatitis B Vaccine form
Hepatitis B Vaccine
UW Bloodborne Pathogen Training
Needs to be filled out unless you have already done so in the past If you have had vaccinations, check the line stating this, put in date or year If you decline the vaccination, check this line, sign and date
Call your Employee Health Center for an appointment – FREE – During work hours EH&S
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ECP-Medical Management
Parenteral (break through skin): Immediately thoroughly wash wound with sudsing soap and water—for 15 minutes.
Mucous Membrane: Immediately thoroughly flush mucous membrane with water for 15 minutes.
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Call UW Employee Health Center at 206685-1026 – Harborview Sites: 206-744-3081 After hours or clinic is closed, go to nearest Emergency Room (ER) Call 911
EMERGENCY POSTER: http://www.ehs.washington.edu/manuals/posters/ehs exposureresponseposter.pdf
2. GET Medical Help EH&S
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How to Get Medical Help?
1. DO First Aid
•
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ECP-Medical Management
What to do if exposed? •
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Health Care Professional Written Opinion
ECP-Medical Management:
Post Exposure Evaluation
Health Care Professional’s Written O Use with Chapter 296
Document exposure incident and ID source
______________________________________
Date of Incident:
______________________________________
t
Date of Evaluation:
______________________________________
Health Pro fessional’s Address:
Testing and PostExposure treatment
Counseling
Evaluation and follow-up
______________________________________ ______________________________________
Health Professional’s Telephone:
pinion For Post -Exposure Evaluation
-823 WAC, Occupational Exposure to Bloodborne Pathogens
Employee’s Name:
______________________________________
____
The employee named above has been in formed of the results of the evaluation for exposure to blood or other potentially infectious materials.
____
The employee named above has been told about any health conditions resulting from exposure to blood or other potentially infectious materials whi ch require further evaluation or treatment.
____
Hepatitis B vaccination
is ____ is not ____ indicated.
Employee to receive within 15 days
________________________________ Health Care Professional’s Name ___________________________________ Health Care Professio nal’s Signature
__________________________ Date
Return this form to the employer and provide a copy to the employee within 15 days. Please label the outside of the envelope “Confidential.” Employer’s Name Employer’s Address :
_____________________________________________ _____________________________________________ _____________________________________________
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5.
Hazard Communication
Annual UW BBP training
Laboratory specific hazards training Exposure Control Plan – annual review EH&S
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Additional Requirements HIV/HBV/HCV Research Labs
Training – Demonstrated proficiency-microbiological practices and practices and operations specific to the facility BEFORE work w/virus. UW Bloodborne Pathogen Training
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Record Keeping Training records- EH&S and PI- keep 3 years Medical records-kept at Employee Health Center for duration of employment plus 30 years You &/or Supervisor fill out the OARS (online) report after incident-EHS EH&S
Labs doors closed when working with virus No bench work/must use BSC Limited needle/syringe use Limited access only to those aware of hazards PPE in labs—NOT to be worn outside lab, decontaminated before laundered.
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Training
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Resources
Lab specific biosafety manual-reviewed annually Special Practices – – – – –
EH&S UW Bloodborne Pathogen _________________ _______________________________
ECP-Records
ECP- Hazard Communication 4.
Confidential Fax:
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International Sharps Injury Prevention Society (ISIPS): http://www.isips.org/ WA State Department of Safety and Health BBP page: http://www.lni.wa.gov/Safety/Topics/AtoZ/BBP athogens/default.asp Centers for Disease Control and Prevention (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL)website: http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bm bl5toc.htm EH&S
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QUESTIONS?
Resources
EH&S Site-Specific Exposure Control Plan: http://www.ehs.washington.edu/forms/rbs/res earchlaboratorysupplementalform.doc Specimen Handling Transport EH&S Class: http://www.ehs.washington.edu/eposhiphazma t/index.shtm
Be sure to look at your workplace Exposure Control Plan! See you next year… online!
EH&S Research and Occupational Safety: 206-221-7770,
[email protected], http://www.ehs.washington.edu/rbs/bbp.shtm
"I hear & see - I learn, but may forget, But if I do, I understand."
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HEPATITIS B VACCINE WHAT YOU NEED TO 1
What is hepatitis B?
Hepatitis B is a serious disease that affects the liver. It is caused by the hepatitis B virus (HBV). HBV can cause: Acute (short-term) illness. This can lead to: • loss of appetite • diarrhea and vomiting • tiredness • jaundice (yellow skin or eyes) • pain in muscles, joints, and stomach Acute illness is more common among adults. Children who become infected usually do not have acute illness. Chronic (long-term) infection. Some people go on to develop chronic HBV infection. This can be very serious, and often leads to: •liver damage (cirrhosis) •liver cancer •death
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KNOW
Hepatitis B vaccine: Why get vaccinated?
Hepatitis B vaccine can prevent hepatitis B, and the serious consequences of HBV infection, including liver cancer and cirrhosis. Routine hepatitis B vaccination of U.S. children began in 1991. Since then, the reported incidence of acute hepatitis B among children and adolescents has dropped by more than 95% – and by 75% in all age groups. Hepatitis B vaccine is made from a part of the hepatitis B virus. It cannot cause HBV infection. Hepatitis B vaccine is usually given as a series of 3 or 4 shots. This vaccine series gives long-term protection from HBV infection, possibly lifelong.
Chronic infection is more common among infants and children than among adults. People who are infected can spread HBV to others, even if they don’t appear sick.
Children and Adolescents
• In 2005, about 51,000 people became infected with hepatitis B.
• All children should get their first dose of hepatitis B vaccine at birth and should have completed the vaccine series by 6-18 months of age.
• About 1.25 million people in the United States have chronic HBV infection. • Each year about 3,000 to 5,000 people die from cirrhosis or liver cancer caused by HBV. Hepatitis B virus is spread through contact with the blood or other body fluids of an infected person. A person can become infected by: - contact with a mother’s blood and body fluids at the time of birth; - contact with blood and body fluids through breaks in the skin such as bites, cuts, or sores; - contact with objects that could have blood or body fluids on them such as toothbrushes or razors; - having unprotected sex with an infected person; - sharing needles when injecting drugs; - being stuck with a used needle on the job.
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Who should get hepatitis B vaccine and when?
• Children and adolescents through 18 years of age who did not get the vaccine when they were younger should also be vaccinated. Adults • All unvaccinated adults at risk for HBV infection should be vaccinated. This includes: - sex partners of people infected with HBV, - men who have sex with men, - people who inject street drugs, - people with more than one sex partner, - people with chronic liver or kidney disease, - people with jobs that expose them to human blood, - household contacts of people infected with HBV, - residents and staff in institutions for the developmentally disabled, - kidney dialysis patients,
- people who travel to countries where hepatitis B is common, - people with HIV infection. • Anyone else who wants to be protected from HBV infection may be vaccinated.
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Who should NOT get hepatitis B vaccine?
• Anyone with a life-threatening allergy to baker’s yeast, or to any other component of the vaccine, should not get hepatitis B vaccine. Tell your provider if you have any severe allergies. • Anyone who has had a life-threatening allergic reaction to a previous dose of hepatitis B vaccine should not get another dose. • Anyone who is moderately or severely ill when a dose of vaccine is scheduled should probably wait until they recover before getting the vaccine. Your provider can give you more information about these precautions. Pregnant women who need protection from HBV infection may be vaccinated.
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Hepatitis B vaccine risks
Hepatitis B is a very safe vaccine. Most people do not have any problems with it. The following mild problems have been reported:
reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? • Call a doctor, or get the person to a doctor right away. • Tell your doctor what happened, the date and time it happened, and when the vaccination was given. • Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967. VAERS does not provide medical advice.
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The National Vaccine Injury Compensation Program
In the event that you or your child has a serious reaction to a vaccine, a federal program has been created to help pay for the care of those who have been harmed. For details about the National Vaccine Injury Compensation Program, call 1-800-338-2382 or visit their website at www.hrsa.gov/vaccinecompensation.
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How can I learn more?
• Soreness where the shot was given (up to about 1 person in 4).
• Ask your doctor or nurse. They can give you the vaccine package insert or suggest other sources of information.
• Temperature of 99.9°F or higher (up to about 1 person in 15).
• Call your local or state health department.
Severe problems are extremely rare. Severe allergic reactions are believed to occur about once in 1.1 million doses. A vaccine, like any medicine, could cause a serious reaction. But the risk of a vaccine causing serious harm, or death, is extremely small. More than 100 million people have gotten hepatitis B vaccine in the United States.
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What if there is a moderate or severe reaction?
What should I look for? • Any unusual condition, such as a high fever or behavior changes. Signs of a serious allergic
• Contact the Centers for Disease Control and Prevention (CDC): - Call 1-800-232-4636 (1-800-CDC-INFO) - Visit CDC websites at: www.cdc.gov/ncidod/diseases/hepatitis www.cdc.gov/vaccines www.cdc.gov/travel
department of health and human services Centers for Disease Control and Prevention Vaccine Information Statement (Interim) Hepatitis B (7/18/07) 42 U.S.C. § 300aa-26