EXPOSURE CONTROL PLAN FOR BLOODBORNE DISEASE
Occupational Safety & Health Admin. (OSHA)
Center for Disease Control's MMWR
LUMC - Occupational Health Services Policies
Department of Medicine
Attendance of employees at these educational programs will be documented by
dated sign-in sheets. Training sessions will be held for new employees before they
are assigned to tasks where potential exposure to infectious material could occur.
Training sessions for all employees will be provided on an annual basis thereafter
or whenever there are significant changes in the content of the Exposure Control Plan.
Training will also be provided to existing employees if there are changes in job
classification or tasks that could result in a significant risk of exposure to bloodborne
The content, date, and names and qualifications of individual conducting training sessions will be affixed to the master copy of this Exposure Control Plan and maintained as part of a permanent record in the administrative offices of the Department of Medicine for a period of at least three years. Employee training records will be available to all parties duly authorized to receive them as outlined in OSHA's regulatory text.
|Blood||human blood, human blood components, and products made from human blood.|
|Bloodborne pathogens||pathogenic micro-organisms such as hepatitis and AIDS viruses that are present in human blood and capable of causing disease|
|Contaminated||presence or reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.|
|Contaminated laundry||laundry which has been soiled with blood or other potentially infectious materials.|
|Contaminated sharps||any contaminated object that can penetrate the skin, including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires.|
|Decontamination||use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or items so that they are no longer capable of transmitting infection.|
|Engineering controls||methods or equipment, i.e., sharps disposal containers, self-sheathing needles, that isolate or remove the hazard of bloodborne pathogen from the work place.|
|Exposure incident||a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials.|
|Hand washing facilities||an adequate supply or running potable water, soap and single use towels or hot air drying machines.|
|Parenteral||Piercing of mucous membranes or the skin barrier by needle sticks, human bites, cuts and abrasions.|
|Personal protective equipment||specialized clothing or equipment worn by an employee for protection from a hazard. General work clothes, i.e., uniforms, pants, or blouses, not intended to function as protection against a hazard are not considered personal protective equipment.|
|Regulated wastes||liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps, pathological and microbiological wastes containing blood or other potentially infectious materials.|
|Research laboratory||a laboratory producing or using research laboratory scale amounts of human immunodeficiency (AIDS) or hepatitis virus. Research laboratories may produce high concentrations of HIV or HBV but in the volume found in production facilities.|
|Source individual||any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. Examples include hospital and clinic patients; trauma victims, clients of drug and alcohol treatment programs; residents of hospice or nursing homes; human remains; and individuals who donate or sell blood or blood components.|
|Sterilize||the use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial endospores.|
|Universal precautions||an approach to infection control. According to the concept of universal precautions, all human blood and certain human body fluids are treated as if known to be infectious for AIDS and hepatitis viruses and other bloodborne pathogens.|
|Work practice controls||methods of reducing the likelihood of exposure by altering the manner in which a task is performed, i.e., prohibiting recapping of needles by the two-handed technique.|
Every individual employed by or working in the Department of Medicine has the right to:
The Department of Medicine has the right to mandate that all employees will:
Bloodborne disease, especially hepatitis and AIDS, may be:
Your health depends on active prevention
Material in red plastic bags, sharps containers, or items with the following label warn you a high risk for potential infection. These objects must be handled with extreme caution.
To prevent injury to others, you have an obligation to affix the above warning labels to potentially contaminated items such as refrigerators, freezers, equipment, and disposal or shipping containers used to store, transport or ship blood or tissues.
Transmission of bloodborne disease may occur by:
How to prevent bloodborne disease:
The manager of your unit, laboratory or area is responsible for stocking and instructing you in the use, cleaning and proper disposal of personal protective equipment. If adequate supplies or disposal systems are not available, it is your responsibility to notify the manager immediately.
General work clothes such a uniforms, pants, shirts and blouses are not considered to be personal protective equipment.
All personal protective equipment must be removed and placed in proper containers before leaving your work area. You must wash your hands immediately after removal of gloves or other personal protective equipment.
Required Protective Equipment
|Procedure *||Hand Washing||Gloves||Mask||Shields/Goggles||Gown|
|Amniotic fluid handling||x||x|
|Blood specimen handling||x||x|
|Bone marrow aspiration||x||x|
|Frank GI bleeding||x||x||x||x||x|
|Insert central venous line||x||x|
|Wound dressing change||x||x||x|
* Gowns, masks, face shields or goggles should always be used if splashing, spraying or aerosolization is likely.
Gray Infectious Waste
|Ascitic fluid||NG tubes|
|Bandages||Pap smear spatula|
|Bladder catheters||Peritoneal dialysis fluid|
|Bladder irrigation fluid||Pleural fluid|
|Blood bags and tubing||Rectal tubes|
|Blood from GI tract||Stomach irrigation fluid|
|Central venous lines||Suction tubes|
|Colostomy bags||Swan-Ganz catheters|
|Dialysis tubing||Test tubes|
|Dressing||Urine drainage bags|
|Endotracheal tubes||Urine specimen containers|
|Gloves||Vaginal speculum (plastic)|
|IV catheters without needles||Vomitus|
|Manometers (CSF)||Wound irrigation fluid|
|Sharps Disposal Unit||Linen Bags|
|Broken glass||Bed linens|
|Needles of all types||Laboratory coats|
Any item that could penetrate the skin should be disposed of in a sharps container. If you are unsure about any other item, use the gray infectious medical waste container.
Soap and water are adequate for cleaning glassware and some instruments. Equipment, instruments and work surfaces that will not be corroded may be cleaned with a 1:10 bleach solution (1 part household bleach to 10 parts water) or other appropriate chemical germicide. Each work area must maintain a written record that documents the cleaning of equipment, tools, instruments and surfaces that are potentially contaminated with infectious materials. If overt contamination occurs, decontamination must be performed immediately or as soon as feasible. If the surface or equipment may have been contaminated, cleaning must occur at the end of each work shift.
Disposable coverings for equipment and work surfaces must be replaced immediately if they are overtly contaminated or at the end of each shift if they may have become contaminated. Proper containers must be used for the disposal of these items.
Reusable storage receptacles of all types must be cleaned immediately if they are grossly contaminated and on a weekly basis if there is a reasonable probability that they have become contaminated.
If you believe you have been contaminated:
Health Service Policy
|Subject:||Needlesticks, exposures to blood and body fluids: Treatment for accidental exposures to blood or body fluids|
Contact with blood or other body fluids to which universal precautions apply through percutaneous inoculation or contact with an open wound, non-intact skin (chapped, abraded or dermatitis) or mucous membranes through the performance of normal job duties.
Universal precautions apply to blood, certain other body fluids (amniotic fluid, synovial fluid, cerebrospinal fluid, semen with vaginal secretions), or any body fluid visibly contaminated with blood, and laboratory specimens that contain HIV. Since HIV and HBV transmission has not been documented from exposure to other body fluids (feces, nasal secretions, sputum, sweat, tear, urine, and Vomitus), universal precautions do not apply to these fluids. Universal precautions also do not apply to saliva, except in the dental setting where saliva is likely to be contaminated with blood.
Individual from whom the blood or body fluids resulting in the exposure originated.
Transfusion of blood;
A large volume injection of blood (more than 1 ml);
A parenteral exposure to laboratory materials containing a high titer of virus.
Definite Parenteral Exposure:
Intramuscular (deep) injury with a blood/body fluid contaminated needle;
An injection of blood/body fluids;
Laceration or similar wound produced by a visibly blood/body fluid contaminated instrument which causes bleeding in the health care worker;
Laceration or similar fresh wound inoculated with blood/body fluids;
Any parenteral inoculation of HIV/HBV virus samples, usually in research studies.
Possible Parenteral Exposure:
Subcutaneous (superficial) injury with blood/body fluid contaminated needle;
Wound produced by blood/body fluid contaminated instrument which does not cause visible bleeding;
Prior wound or skin lesion contaminated with blood/body fluids;
Mucous membrane inoculation with blood/body fluids.
Doubtful Parenteral Exposure:
Subcutaneous (superficial) injury with a needle or device contaminated with non-infectious, non-bloody fluids;
A wound produced by non-infectious body fluid contaminated instrument;
Prior wound or skin lesion contaminated with non-infectious body fluids;
Mucous membrane inoculation with non-infectious body fluids.
Intact skin visible contaminated with blood/body fluids.
Medical Treatment of the Injury
Skin injuries should be cleaned with soap and running water immediately. Eye and mucous membrane splashes should be rinsed with water immediately. Further treatment and follow-up instructions will be as indicated under "Skin Injuries".
Tetanus and diphtheria toxoid (Td) 0.5 ml IM should be administered if:
The immunization history is uncertain
The primary series is not complete
More than 10 years has passed since the last dose of Td
The wound is severe and/or contaminated and more than 5 years has passed since the last dose of Td
Contraindications to the use of Td do not exist. Contraindications include a history of severe hypersensitivity reaction or neurologic complication following injection of Td in the past
Hepatitis B Prophylaxis
If the exposed employee has previously received three doses of
the hepatitis B vaccine, determine if the employee is a responder or a non-responder.
Check the medical record for documentation of a HBsAb at least one month after vaccination
was completed and within the last 24 months. If there is no record of HBsAb within the
last 24 months, draw HBsAb.
Responders to the vaccine have a positive HBsAb documented at least one month after three or more doses of the vaccine and are considered immune to hepatitis B.
Non-responders have a negative HBsAb documented at least one month after the third dose of the vaccine and have never had a positive HBsAb documented. Non-responders may be offered up to three additional doses of the hepatitis B vaccine. A HBsAb should be drawn one month after each additional dose to determine if the non-responder has become a responder. If the HBsAb is negative after four does of the hepatitis B vaccine, the exposed employee should be treated as not immune to hepatitis B.
If the exposed employee is a responder and a positive HBsAb has been documented in the last 24 months, no treatment is necessary.
If the exposed employee is a responder and a current HBsAb is negative and
If the source HBsAg is positive, a booster dose of hepatitis B vaccine should be administered.
If the source HBsAg is negative or unknown, no treatment is necessary.
If the exposed employee is a non-responder (HBsAb negative) after four doses of the hepatitis B vaccine and therefore not immune to hepatitis B and:
If the source HBsAg is positive, administer Hepatitis B Immune
Globulin (HBIG) 0.6 ml/kg or 5 ml IM as soon as possible after injury and repeat the same
dose in one month.
Alternatively, the employee may receive HBIG as above and an additional dose of the hepatitis B vaccine. The second dose of the HBIG can be omitted if the HBsAb in one month is positive.
If the source of HBsAg is negative or unknown and not high risk, no further action is required.
If the source of HBsAg is unknown and high risk, consider treating as if the source were HBsAg positive.
If the exposed employee is a non-responder (HBsAb negative) after three doses of the hepatitis B vaccine and
If the source HBsAg is positive, administer Hepatitis B Immune Globulin (HBIG) 0.6 m./kg or 5 ml IM and a fourth dose of the hepatitis B vaccine. The employee should return for repeat HBsAb in one month. If HBsAb at this time is positive, no further action is required. If HBsAb at this time is negative, administer a second dose of HBIG.
If the source HBsAg is negative or unknown and not high risk, no further action is required.
If the source HBsAg is unknown and high risk, consider treating as if the source were HBsAg positive.
If the exposed employee has previously received one or two doses of the hepatitis B vaccine and
If the source HBsAg is positive, administer Hepatitis B Immune Globulin (HBIG) 0.6 ml/kg or 5 ml IM and complete the hepatitis B vaccination series as scheduled.
If the source of HBsAg is negative or unknown, complete the hepatitis B vaccination series as scheduled.
If the exposed employee has not received any doses of the hepatitis B vaccine, and
If the source HBsAg is positive, administer Hepatitis B Immune Globulin (HBIG) 0.6 ml/kg or 5 ml IM, then administer first dose of hepatitis B vaccination at a separate site (deltoid) and encourage employee to comply with the two additional doses.
If the source HBsAg is negative or unknown, then administer first dose of hepatitis B vaccination and encourage employee to comply with two additional doses.
Hepatitis B vaccination is recommended for all health care
workers and housekeepers at the time of employment.
Any employee who does not wish to be vaccinated will be asked to sign a statement to that effect. This statement can be rescinded at any time.
Hepatitis B vaccination includes three does of 1.0 ml each given in the deltoid. The second and third doses should be given 1 and 6 months after the first.
Post vaccination testing will be done one month after the series is completed in order to classify vaccines as responders or non-responders. Non-responders who received three doses in the deltoid will be offered up to three additional doses of the hepatitis vaccine. HBsAb will be rechecked 1 month after each additional dose.
Patients who are undergoing dialysis, Immunosuppressed or HIV infected should be referred to the OHS physician prior to hepatitis B vaccination.
Patients allergic to yeast should receive Heptavax-B.
Hepatitis C Prophylaxis
Effective hepatitis C prophylaxis is as yet undetermined. If an employee sustains a needlestick from a source who is known to have hepatitis C, the employee may be offered Immune Globulin 0.06 ml/kg. This should be administered as soon as possible after exposure.
All employees who present within 24 hours of sustaining accidental exposures to blood or body fluids will be offered AZT prophylaxis and asked to review the informed consent (see below).
While AZT prophylaxis will be available to all injured employees, OHS physicians will encourage only employees who have sustained "significant" exposures to HIV positive sources to use AZT prophylaxis. "Significant" will be defined as a massive exposure or definite parenteral exposure as described above under IIA and B. OHS physicians will discourage employees with HIV negative or HIV unknown exposures to use AZT as post-exposure prophylaxis.
A physician will be available to counsel the employee about HIV exposure.
A baseline HIV antibody test will be drawn on exposed employees. Follow-up HIV antibody testing of the exposed employee will be done at 6 weeks, 12 weeks, and 6 months. Additionally, HIV testing will be done at any time upon request.
If the exposed employee does not consent to HIV testing, the employee's serum will be saved for 90 days so that HIV testing can be done if the employee changes his/her mine and gives consent.
In order to receive AZT as post-exposure prophylaxis, the exposed employee will have to sign the informed consent, thereby agreeing to:
MD follow-up visits every two weeks and as indicated.
Laboratory testing including:
Baseline CBC, SMAC, pregnancy test, and HIV.
Follow up CBC's every two weeks during treatment.
HIV testing at 6 weeks, 12 weeks, and 6 months.
Other laboratory tests as indicated.
Contraindications to the use of prophylactic AZT include:
1. Concurrent pregnancy
2. Severe renal, hepatic, or hematologic disease as reflected on the baseline CBC and SMAC.
In addition to counseling by a health care provider, the injured employee will receive a copy of "What To Do After Accidental Exposure to Blood and Body Fluids." Included is a copy of "Universal Precautions to Prevent Transmission of HIV". A physician will be available to answer any questions which arise.
Every effort will be made to determine the HBsAg and HIV antibody of the source in a timely manner. If any of these results is positive, the exposed employee will be notified as soon as possible. The source's physician will also be notified promptly of positive test results. Follow up and counseling of the source will be the responsibility of his/her physician.
Health Service Policy
|Subject:||Needlesticks, exposures to blood and body fluids: Informed consent for post-exposure Zidovudineuse|
Because you have been exposed to blood or body fluids which may be infected with the AIDS virus or HIV, you are being offered treatment with zidovudine (AZT) to possibly prevent HIV infection and AIDS. AZT is being offered at hospitals across the country for this use even though there is no clear documentation that it works and no physician consensus as to whether AZT should be used in this setting. At this time, we are presenting you with the information necessary to make an informed decision as to whether you want to take AZT. The decision is solely up to you.
Considerations regarding the use of AZT after exposure:
The risk of HIV infection following needlestick or other percutaneous exposure to body fluids contaminated with the AIDS virus is estimated to be 0.4% (or less than 1/2 of 1 percent). After mucous membrane or skin exposure to HIV infected blood or body fluids, the risk of infection is even less.
AZT is being offered after exposure in hopes of preventing a presently incurable illness. It is important to understand that AZT has not been approved by the FDA for this use and that there are no studies to document the effectiveness of AZT in preventing HIV infection in the setting. The rationale for its use comes from animal studies showing that AZT favorably alters the course of viral infections which are only distantly related to HIV.
These studies do show that AZT is more effective when started within hours of exposure. Therefore, we recommend that if you decide to take AZT, you take the first dose as soon as possible.
Employees, students, or other personnel who report exposures which may place him/her at risk of HIV infection. These exposures include percutaneous injury (needlestick or cut with a sharp object), mucous membrane contact or skin contact with blood, semen, vaginal secretions, or other body fluids contaminated with blood, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, amniotic fluid, and laboratory specimens containing HIV.
AZT will not be offered to exposed employees who present more than 24 hours after injury. To be effective, AZT prophylaxis must begin as soon as possible after the exposure.
Women of child-bearing age who are not pregnant. A pregnancy test will be done before AZT is prescribe.
You must agree to use effective contraception during treatment.
If you have pre-existing kidney, liver, or bone marrow diseases, you will be excluded because of drug toxicity.
You must review and sign the informed consent and agree to comply with follow up medical care in order to receive AZT treatment.
The Occupational Health Service will try to find out whether or not the source of the exposure is infected with the AIDS virus. AZT can be taken on an interim basis until such information can be obtained.
The minimum effective dose of AZT for use after exposure is not known. The Occupational Health Service is offering 200 mg of AZT every 4 hours around the clock (or six doses a day) for six weeks, the same dose as that offered at the National Institutes of Health. An alternate dosing schedule is that offered at the San Francisco General Hospital: AZT 200 mg five times a day (omitting the 4 am dose) for 4 weeks. There is no evidence that either dosing schedule is more effective. You may choose either one.
AZT will be provided by the Occupational Health Service in amounts which coincide with medical follow up. If you fail to keep you regular appointments listed below under "Medical Follow-Up", we will be unable to prescribe the drug.
The cost of AZT and all related medical care will be covered by the hospital.
Side Effects and Toxicity:
Side effects of AZT can include nausea, vomiting, fatigue, headache and muscle aches. In healthy people, rare side effects include severe anemia, neutropenia. and thrombocytopenia (lowered blood cell counts). When side effects are severe, the drug is discontinued.
The effect of AZT on concurrent and future pregnancy is not known. In order to protect an unborn child, the Occupational Health Service will not provide AZT to pregnant women or to anyone who does not agree to use an effective form of contraception during treatment.
Similarly, nursing women should not breast-feed while taking AZT.
Regular medical care in the Occupational Health Service is required in order to receive AZT. This will include:
MD visits at the start of treatment and every 2 weeks while taking AZT.
CBC, pregnancy test, BUN, creatinine, liver function tests, and HIV at the start of treatment.
CBC every 2 weeks while taking AZT.
HIV testing at 6 weeks, 12 weeks and 6 months.
Additional medical care as indicated.
A physician will be available in the Occupational Health Service or the Emergency Department to answer your questions.
Consent to Treatment
I have reviewed the above information regarding the rationale, dosage, side effects, and follow-up medical care for prophylactic treatment with AZT after exposure. I agree to use effective contraception and if female, not to breast-feed during treatment. I agree to comply with medical follow-up as described.
Health Service Policy
|Subject:||Needlesticks, exposures to blood and body fluids: What to do after accidental exposure to blood or body fluids|
The Occupational Health Service has developed treatment guidelines to prevent you from acquiring infections following an accidental exposure to blood. Possible subsequent infections include hepatitis B, hepatitis C, HIV (AIDS) and tetanus. AIDS generally causes the most concern.
When you report an accidental needlestick, mucous membrane, or open wound exposure, the most important first measure taken will be to clean the area immediately. Tetanus, hepatitis and HIV prophylaxis will then be given if indicated. Hepatitis B is a particularly worrisome threat for the health care worker because of its high rate of transmission, 6-30% following incidental exposures, and the potential for developing chronic liver disease. Fortunately, a safe and effective vaccine to prevent hepatitis B exists. We encourage all healthcare workers to be vaccinated.
Your risk of developing HIV infection depends on the type of exposure. You probably already know that the usual routes of transmission of HIV infection are sexual contact, blood transfusion and communal intravenous drug abuse. These all carry a high risk of infection. In the hospital setting, the risk to health-care workers in much lower. The highest rate of transmission of HIV infection in health-care workers follows accidental percutaneous needlestick. The risk is estimated at less than 1/2 percent per needlestick contaminated with HIV infected secretions. Other exposures including exposure of open wounds or mucous membranes to HIV infected blood or secretions have an even lower rate of transmission of HIV infection. Casual contact with AIDS patients will not result in transmission of infection.
It is not known whether the blood or secretions were contaminated with the AIDS virus, an attempt will be made to find out. The final results may not be ready for 2 weeks. We will advise you of the results. If the blood or secretions were not infected with HIV, no further treatment is necessary.
If the blood or secretions were infected with HIV, or the HIV serology is unknown and cannot be found out, we recommend that you be tested for this antibody to HIV to find out if the exposure resulted in HIV infection. This requires a series of blood tests.
The first test will be done soon after the exposure as a baseline study. It will not tell us whether this exposure caused infection or not. It will only tell us if you were previously infected.
Seroconversion, or change in the HIV test from negative to positive, usually occurs between 3 weeks and 3 months after exposure. Seroconversion may be associated with a mono-like illness with fever, malaise, lethargy, muscle aches, enlarged lumps or "glands" on the neck, in the underarms, and in the groin and sore throat. If you notice any of the symptoms, please contact the Occupational Health Service at 216-4397.
Blood tests done at 6 weeks, 12 weeks and 6 months after exposure are done to detect seroconversion. These tests results will tell us if the exposure resulted in HIV infection. After 3 months, the likelihood of seroconversion is much less. Test results may take up to two weeks. We will advise you of the results.
Especially for the first 12 weeks after exposure to HIV infection, we recommend that you follow "safe sex" practices to eliminate the possibility of transmitting the virus to others. Specifically, this means using a condom during sex. Also, mothers should not breast-feed if there is a possibility of HIV infection, men should not donate semen, and you should refrain from blood and organ donation during this period. If the final test at 6 months is negative, you have not acquired HIV infection from this exposure and these precautions will no longer be necessary unless you have other habits which put you at risk for becoming infected with HIV.
Finally, approximately forty percent of accidental exposures are preventable. Common preventable exposures result from recapping of used needles by hand, improper disposal of needles and other sharp instruments, and contamination of unprotected open wounds. Please review the attached CDC recommendations for universal precautions. We believe that practicing these will decrease the likelihood of similar accidental exposures occurring in the future. If you have questions or concerns, feel free to make an appointment to discuss them with the Occupational Health Service physician.