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EMPLOYEE RIGHTS AND RESPONSIBILITIES
This Plan was developed by the University of Tennessee, Memphis, as a means to eliminate or
minimize employee exposure to blood and other potentially infectious materials.
It is necessary and essential that any employee in this office whose duties involve any reasonably
anticipated contact with or exposure to blood or any other potentially infectious material do the
following:
A. Read and understand the Exposure Control Plan devised by UT Memphis.
B. Ask the Exposure Control Manager, as designated by the Department of the
University of Tennessee, Memphis, any questions you might have regarding the
Exposure Control Plan.
C. Sign an agreement provided to you by the Exposure Control Manager stating that
you have thoroughly read and understand the Exposure Control Plan and will abide
by the provisions of our Exposure Control Plan as long as you are employed by UT
Memphis. (see "Record- keeping" - "Employee Confirmation")
EMPLOYEE CONFIRMATION
By signing this statement I am stating that I have read and understand the Exposure Control Plan of
the office of , University of Tennessee, Memphis.
I am further stating that I shall utilize my best efforts to abide by this Exposure Control Plan.
_____________________________________________________________________________
Employee's signature Witness
_____________________________________________________________________________
Employee's name - printed
_____________________
Date
SCHEDULE OF IMPLEMENTATION
Federal law (OSHA Bloodborne Standard) mandates that health care employers who have
employees exposed to bloodborne pathogens and other potentially infectious materials must
complete certain sections of the Standard by the following dates:
DATE DATE
SECTION OF THE RULE REQUIRED IMPLEMENTED
Exposure control plan 5/5/92
Exposure determination 5/5/92
Training 6/4/92
Record-keeping 6/4/92
Methods of compliance 7/6/92
HBV vaccination/post exposure 7/6/92
procedures
Labeling/Communication 7/6/92
of Biohazard Materials
EXPOSURE CONTROL PLAN FOR
UNIVERSITY OF TENNESSEE, MEMPHIS
A. GENERAL
This plan is being implemented and observed as a means of minimizing or eliminating bloodborne
pathogen exposure to employees of the University. This plan shall contain information concerning
the policies, procedures and records of this office with regard to:
* Exposure Determination
* Labeling/Hazard Communication
* HBV Vaccination
* Engineering Controls
* Personnel Protective Equipment
* Housekeeping
* Record-keeping
B. EXPOSURE CONTROL MANAGER
As an employee of the University this Exposure Control Plan is available to you, upon request,
during normal business hours, and is available at
(Location)
has been designated by this office as the
(Name)
individual responsible for the completion, implementation and maintenance of this Exposure
Control Plan.
C. RECOMMENDATION
This Exposure Control Plan contains spaces in each section for the completion of applicable
information. It is strongly recommended before completion of information that the blank forms be
duplicated for future use or modification.
EXPOSURE DETERMINATION
A. GENERAL
The OSHA Standard describes how to determine which health care employees have occupational
exposure to bloodborne pathogens. OSHA defines occupational exposure as reasonably
anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially
infectious materials that may result from the performance of an employee's duties.
Other potentially infectious materials include:
* Semen
* Vaginal Secretions
* Cerebrospinal Fluid
* Synovial Fluid
* Pleural Fluid
* Pericardial Fluid
* Peritoneal Fluid
* Amniotic Fluid
* Saliva in Dental Procedures
* Any bodily fluids visibly contaminated with blood
* All body fluids where it is difficult or impossible to
differentiate between body fluids
* An unfixed tissue or organ from a human (living or dead)
B. EXPOSURE DETERMINATION FORMS
The sample exposure determination forms that follow will help you identify and classify your
employees as follows:
* a list of all job classifications in which all employees in
those job classifications have occupational exposure;
* a list of job classifications in which some of the
employees have occupational exposure; and
* a list of employees that are never exposed (ie. office
manager)
* personal protective equipment to be utilized in said tasks
This exposure determination shall be made without regard to the use of personal protective
equipment.
METHODS OF COMPLIANCE
The following procedures and concepts required by OSHA have been adopted by the University
for the health, safety and well-being of our employees.
A. UNIVERSAL PRECAUTIONS
"Universal Precautions" is OSHA's preferred method of control to protect employees from
exposure to all human blood, certain human body fluids and Other Potentially Infectious Material
(OPIM; see glossary). The term "Universal Precautions" refers to a concept of bloodborne
diseases control which requires that all human blood and OPIM be treated as if known to be
infectious for HBV, HIV, or other bloodborne pathogens regardless of the perceived "low risk" of
a patient.
B. ENGINEERING AND WORK PRACTICE CONTROLS
Employers are required by OSHA to develop and implement engineering and work practice
controls as the primary means of eliminating or reducing employee exposure. In the event that a
risk of occupational exposure still exists after implementation of engineering and work practice
controls the employer will provide and ensure that employees utilize personal protective equipment
as additional protection.
1. Handwashing
* Employees will wash their hands and any exposed skin areas with at least
soap and water immediately or as soon as feasible upon contact with blood,
certain body fluids, or OPIM.
* Employee's mucous membranes that become exposed will be flushed
thoroughly with water or equivalent substitute immediately or as soon as
feasible.
* Upon removal of gloves or other Personal Protective Equipment, employees
will use soap and water to wash their hands immediately or as soon as
feasible.
* Should handwashing facilities be unavailable, the employee will use either
an antiseptic cleanser or towelette; however, when antiseptic cleansers or
towelettes are utilized, hands will be washed with soap and water as soon as
possible.
Self-Evaluation of Control
1. In this office handwashing facilities are located at:
(ex. "exam rooms")
2. The soap or cleanser used is:
(ex. Hibiclens)
3. Employees wash hands after all patient contact.
Yes/No
4. Employees wash hands after any glove removal.
Yes/No
2. Handling of Sharps
* Employees will not bend, recap, or remove contaminated needles and other
contaminated sharps except as indicated below:
-contaminated needles and other contaminated sharps will not be removed or
recapped unless the employer can verify and establish that no alternative
method is practical or that the above guideline is required by a specific
medical procedure.
-needle recapping or removal deemed necessary by the employer must be
performed by the employee utilizing mechanical means or a one-handed
"scoop" technique.
* Employees will place contaminated sharps in appropriate, designated
containers until properly reprocessed.
- These containers will evidence the following:
(1) puncture resistance
(2) labeled or color coded in regard to this standard
(3) leak-proof on the sides and bottom
(4) If containing "reusable" sharps such sharps containers should not be
stored or processed in a manner which would require an employee
to reach, by hand, into the container where these sharps have been
placed.
Self-Evaluation of Control
1. Employees may bend, recap or remove contaminated needles or other
contaminated sharps.
Yes/No
If "Yes," only in the following situations and why:
If "Yes," what device or technique is used to prevent punctures
or lacerations?
2. Sharps containers are located at the following areas (as close as possible to
point of use): (ex. "all exam rooms")
3. Filled sharps containers are disposed of by:
(ex. "closed before overfilled and disposed in
medical waste service box")
3. Personal Hygiene
* Employees will not eat, drink, smoke, apply cosmetics or lip balm, or
handle contact lenses in work environments where risk of exposure may
occur.
* Employees will not store food or drinks in refrigerators, freezers, shelves,
cabinets or on countertops or bench tops where blood or other potentially
infectious materials are present.
Self-Evaluation of Control
1. Eating, drinking and smoking is allowed in the following areas
only: (ex. "breakroom or patio, outside of the office")
2. The storage of food or drink is allowed in the following areas only: (ex.
"refrigerator, dining area")
4. Exposure Minimization
* Employees will perform all procedures involving blood, body fluids or
OPIM in such a manner as to minimize splashing, spraying, spattering, and
generation of droplets by these substances.
* Employees will not utilize mouth pipetting to suction blood, body fluids, or
OPIM.
5. Specimens
* Specimens of blood, body fluids, or OPIM will be placed in a designated
container that prevents leakage during collection, handling, processing,
storage, transport, or shipping.
* This container will be labeled with the BIOHAZARD SYMBOL or color
coded in red and closed prior to storage, transportation, or shipping.
* Should contamination of the primary container occur, it must be placed
inside a second container that prevents leakage and is also labeled or color
coded according to standard requirements.
* If a specimen could puncture the primary container, the primary container
must be placed within a second container that is puncture resistant and
labeled or color coded according to standard requirements.
6. Equipment
* Equipment which becomes contaminated with blood, body fluids, or OPIM
must be examined thoroughly before servicing or shipping.
* Such equipment, if contaminated, should be decontaminated unless the
employer demonstrates that the procedure is not feasible for that equipment
or portions of that equipment.
* Labels must be attached to the equipment stipulating which
portion remains contaminated.
* This information must be communicated to all affected employees, service
representatives, and manufacturers before handling, servicing or shipping.
Self-Evaluation of Control
1. The following equipment is periodically shipped or serviced:
Equipment Can Decontaminate
(ex. "forceps") Y/N
2. If decontamination is not feasible, why?
3. If decontamination is feasible, how is it completed?
Process Decontaminant PPE Used
4. Who is responsible for such decontamination?
(name)
(name)
PERSONAL PROTECTIVE EQUIPMENT (PPE)
A. PERSONAL PROTECTIVE EQUIPMENT, or PPE, can be essentially defined as
ancillary body coverings designed to minimize or eliminate exposure to blood or
other potentially infectious materials.
B. PROVISION: When the chance of occupational exposure exists, the University
shall provide, at no cost to the employee, the appropriate PPE in assorted sizes for
proper fit.
* Examples: Gloves, gowns, laboratory coats, face shields or masks, eye
protection, mouthpieces, resuscitation bags, pocket masks, or other
ventilation devices.
C. APPROPRIATE PPE
* PPE will be considered "appropriate" only if it does not permit blood or
other potentially infectious materials 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.
D. ACCESSIBILITY OF EQUIPMENT
* The University shall ensure that appropriate PPE in a variety of sizes shall
be readily accessible, at no cost, to employees including: hypoallergenic
gloves, glove liners, powderless gloves, or other similar alternatives for
those employees who are allergic to the gloves normally provided.
E. USE OF PPE
* The University will strive to ensure that the employee uses appropriate PPE
unless the University can show that the employee temporarily and briefly
declined to use PPE when, under rare and extraordinary circumstances, it
was the employee's professional judgement that in the specific instance use
would have prevented the delivery of health care or public safety services or
would have posed an increased hazard to the safety of the worker or co-
worker. When the employee makes this judgement, the circumstances shall
be investigated and documented in order to determine whether changes can
be instituted to prevent such occurrences in the future.
F. CLEANING, LAUNDERING, AND DISPOSAL OF PPE
* PPE required by OSHA Standard shall be cleaned, laundered, and disposed
of at no cost to the employee(s).
G. REPAIR, REPLACEMENT, REMOVALS
* PPE shall be repaired and/or replaced as needed, at no cost to the employee.
* If a garment is penetrated by blood or other potentially infectious materials,
the garment shall be removed immediately or as soon as feasible.
* All PPE shall be removed prior to leaving the work area.
* When PPE is removed it shall be placed in an appropriately designated area
or container for storage, washing, decontamination, or disposal.
* Designated areas or containers should be labeled with the BIOHAZARD
SYMBOL, red in color or utilizing red bags.
H. GLOVES
* Gloves shall be worn:
-when it can be reasonably anticipated that the employee may have hand
contact with blood or other potentially infectious materials, mucous
membranes, and non- intact skin.
-when performing vascular access procedures.
-when handling or touching contaminated items or
surfaces.
* Disposable (single use, exam) gloves such as surgical or examination
gloves, shall be replaced as soon as 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 (single use, exam) gloves shall not be washed or
decontaminated for re-use.
* Utility gloves shall be discarded if cracked, peeling, torn, punctured, or
otherwise exhibit signs of deterioration, or when their ability to function as
a barrier is compromised.
* The University may determine that routine gloving for all phlebotomists in a
volunteer blood donation center or situation may be deemed not necessary.
If such routine gloving is deemed unnecessary the University shall:
-periodically reevaluate this policy;
-make gloves available to all employees who wish to use
them for phlebotomy;
-not discourage the use of gloves for phlebotomy;
-yet require that gloves may be used for all
phlebotomies in the following circumstances:
a. when the employee has cuts, scratches, or other
breaks in his or her skin;
b. when the employee judges that hand contamination with
blood may occur, for example, when performing
phlebotomy on an uncooperative source individual. (ex.
potentially violent patient);
c. when the employee is receiving training in phlebotomy.
I. MASKS, EYE PROTECTION, AND FACE SHIELDS
Masks shall be worn alone or in combination with eye protection devices such as
goggles or glasses, side shields, face shields, etc. whenever splashes, spray,
splatter or droplets of blood or other potentially infectious materials may be
generated and eye, nose, or mouth contamination can be reasonably anticipated.
J. GOWNS AND OTHER PROTECTIVE BODY CLOTHING
* Appropriate protective clothing such as, but not limited to, long-sleeved
gowns, aprons, long-sleeved lab coats, long- sleeved clinical jackets, or
similar outer garments shall be worn in occupational exposure situations.
The type and characteristics of such protective clothing must be appropriate
to the task and degree of exposure anticipated.
* Each office must designate the appropriate PPE that every employee should
wear during specific treatments or tasks depending on the degree of
exposure anticipated.
* Surgical caps, hoods and/or covers or boots shall be worn in instances
when gross contamination can reasonably be anticipated. (ex. autopsies,
orthopedic surgery, etc.)
Self-Evaluation of Control
1. In this office, the PPE utilized, its availability/location and disposibility is as
follows:
PPE Item Location Dispose or Reuse
(ex. gloves) (ex. exam. rooms) (ex. dispose)
2. In this office, that PPE which is "reused" is cleaned or decontaminated as follows:
Method to Clean
PPE Item or Decontaminate
(ex. lab coats) (ex. send to laundry)
3. In this office, that PPE which is "disposed" is contained as follows:
Receptacle Final
PPE Item Type Waste Receptacle
(ex. gloves) (ex. exam room step can) (ex. Infectious waste
container)
4. In this office, the only situation(s) where PPE may be required, but not utilized, is
as follows: (This does not involve situations where no exposure can occur.)
SITUATION REASON PPE NOT UTILIZED
WORK SURFACE/WASTE CONTAINER CLEANING AND DISINFECTING
A. The University will ensure work-sites shall be maintained in a clean and sanitary
condition.
B. The University will determine and implement an appropriate written schedule for
cleaning and method of decontamination based upon the location and the facility,
type of surface to be cleaned, type of contaminant present, and tasks or procedures
being performed in the area.
C. All equipment, environmental and working surfaces shall be cleaned and
decontaminated after contact with blood or other potentially infectious materials.
D. Contaminated work surfaces shall be decontaminated with an appropriate
disinfectant after completion of procedures;
* Immediately, or as soon as feasible, when surfaces are overtly
contaminated;
* After any spill of blood or other potentially infectious materials; or
* At the end of each workshift if the surface may have become contaminated
since the last cleaning.
E. Protective coverings such as plastic wrap, aluminum foil or imperviously backed
absorbent paper used to cover equipment and environmental surfaces shall be
removed and replaced as soon as feasible when they become overtly contaminated
or at the end of a work shift or if they may have become contaminated during the
shift.
F. All bins, pails, cans and similar receptacles intended for reuse which have a
reasonable likelihood of becoming contaminated with blood or other potentially
infectious materials shall be inspected and decontaminated on a regularly scheduled
basis and decontaminated immediately or as soon as feasible upon visible
contamination.
G. In developing a scheduled program for cleaning and disinfecting the work surfaces
and waste containers the office should consider certain factors, some of which
include:
* Potential for surface or container contamination may reasonably occur;
* Insuring that employees utilize PPE when cleaning and disinfecting;
* Any disinfectant should have a notation on the bottle or can that it is an
EPA-approved tuberculocidal.
Self-Evaluation of Control
1. The cleaning and disinfecting program for this office is:
Surface Type PPE
Room or Container Frequency Disinfectant Used
2. The person(s) responsible for performing the cleaning and disinfecting is:
Name
Name
Name
CONTAMINATED LAUNDRY
A. Shall be handled as little as possible with a minimum of agitation;
B. Shall be bagged or containerized where it was used and shall not be sorted or rinsed
in the area of use;
C. If wet and presents a reasonable likelihood of soaking through or leaking from the
bag or container, the laundry shall be placed and transported in bags or containers
which prevent soaking or leakage of fluids;
D. Shall be placed and transported in appropriately labeled or color- coded bags or
containers labeled with the BIOHAZARD SYMBOL in accordance with the OSHA
Standard.
E. The University shall ensure that employees who have contact with contaminated
laundry wear protective gloves or other appropriate personal protective equipment;
F. Contaminated laundry includes PPE, but not clothing worn under PPE.
G. Should not be taken home by employee to wash.
H. The Centers for Disease Control has determined that contaminated laundry can be
cleaned at the office location without undue HIV risk upon reuse if:
* washed in 180o Fahrenheit
* dried at 212o Fahrenheit
* handled by employees utilizing appropriate PPE
Self-Evaluation of Control
1. The process for handling and cleaning of contaminated laundry in this office is:
How Bagged/ Cleaned
Laundry Type Contained On/Off Site
2. Is the off-site laundry service utilized?
Y/N
3. Laundry service utilizes Universal Precautions?
Y/N
4. When shipping contaminated laundry to a facility that does not utilize universal
precautions, laundry containers shall be appropriately labeled or color-coded in
accordance with the OSHA Standard.
Y/N
5. Should be cleaned or laundered by University at no expense to the employee.
Y/N
BLOODBORNE COMMUNICATION
A. BIOHAZARD SYMBOL
* The above is typically referred to as the universal ³BIOHAZARD
SYMBOL². The lettering and symbol are typically in black or dark print
against an orange or red-orange background. This BIOHAZARD
SYMBOL is a notification to the health care employee that the item or
contents may present a possible occupational exposure, and that appropriate
precautions should be observed.
* This BIOHAZARD SYMBOL should be printed on, or affixed to the
following:
-containers of regulated waste;
-refrigerators or freezers used to store blood or other potentially infectious
materials;
-containers used to store, dispose of, or transport blood or other potentially
infectious materials.
* The BIOHAZARD SYMBOL label does not need to be placed on the
following:
-blood and blood products labeled as to their contents that have been
released for transfusion or clinical use;
-individual containers of blood or other potentially infectious materials if
placed in a larger labeled container;
-decontaminated REGULATED WASTE; or
-containers or bags which are red in color
B. BLOODBORNE PATHOGENS AND THEIR METHODS OF TRANSMISSION
A bloodborne pathogen is defined as a "pathogenic microorganism that is present in human blood
and can cause disease in humans". These pathogens include, but are not limited to, HBV and
HIV.
Although malaria, syphilis and brucellosis are also examples of bloodborne diseases, OSHA's
Final Rule focuses on exposure prevention to HBV and HIV.
* Body Fluids/Substances Which May Contain Bloodborne
Pathogens
-semen
-vaginal secretions
-cerebrospinal fluid
-synovial fluid
-pleural fluid
-pericardial fluid
-peritoneal fluid
-amniotic fluid
-saliva in dental procedures
-any body fluid visibly blood-contaminated
-any unfixed human tissue or organ
-HIV-containing cell or tissue cultures
-HIV-containing culture mediums
-blood or tissue from HIV or HBV infected research animals
* How Exposure to Blood and/or Body Fluids/Substances May
Occur
-an exposure to blood and/or body fluids/substances requires very specific
conditions.
-the fluid/substance must be directly introduced into the person's body.
This means blood and/or body fluids substances must be introduced
through the skin (percutaneous) or by contact with mucous membranes such
as the eye, mouth, or nose.
-a percutaneous exposure occurs when body fluids substances are
introduced through the skin. This can occur by being injured by a
needlestick, sustaining a cut by a sharp object, or having blood and/or
fluids/substances contaminate non-intact skin, that is, an existing wound,
sore, broken cuticle, or chapped skin.
-a mucous membrane exposure occurs when blood and/or body
fluids/substances are splashed into the eye, mouth, or nose.
-there are no known cases of HIV developing after mouth-to-mouth
resuscitation.
-HIV (and HBV) are not transmitted by casual contact or through intact
skin.
-limiting routes of exposure means instituting Universal Precautions to
ensure that health care workers will be adequately protected.
* What does the Term "Universal Precautions" Mean?
Universal Precautions is a concept of exposure/infection control.
-All blood and certain body fluids are considered as potentially containing
bloodborne pathogens.
-This concept is to be followed regardless of whether the health care worker
knows the HBV/HIV status of the patient.
-Utilizing Universal Precautions is also beneficial in reducing the health care
worker's exposure to other types of infection.
* Factors Influencing the Likelihood of Infection with Bloodborne Pathogens
The likelihood of infection after exposure to HIV or HBV depends on:
1. the concentration of the virus (viral concentration is higher for HBV
than HIV)
2. the duration of the contact
3. the presence of skin lesions on the hands of health care workers
4. the immune status of the health care worker (for HBV)
Therefore, immediately and thoroughly wash hands and skin surfaces that are
contaminated with:
1. blood
2. body fluids/substances containing visible blood
3. or other body fluids to which Universal Precautions apply
Remember to wear protective barriers for any anticipated contact with:
1. blood
2. body fluids/substances containing visible blood
3. or other body fluids to which Universal Precautions apply
* How HIV and HBV Are Transmitted
Both HIV and HBV are transmitted in the same way, that is, through:
1. Sexual contact
2. Mucous membrane or parenteral exposure to infected blood and
body fluids/substances
3. Mother/infant (in-utero/perinatally)
The primary potential risk for health care workers is a percutaneous or mucous
membrane exposure to infected blood and body fluids/substances.
-All health care workers are concerned about contracting HIV because of its
fatal outcome.
-Pregnant health care workers are not known to be at greater risk of
contracting HIV or HBV infection than health care workers who are not
pregnant; however, if a health care worker develops an HIV infection
during pregnancy, the infant has a 50 percent risk of infection resulting
from perinatal transmission.
-If a health care worker develops HBV during pregnancy, the infant has a
70 to 90 percent risk of infection resulting from perinatal transmission. The
baby may then become a carrier and has a 25 percent chance of developing
chronic liver disease.
* Symptoms of Hepatitis B Infected Individuals
Approximately 1/3 have no symptoms;
Approximately 1/3 have flu-like symptoms and are not diagnosed with
hepatitis;
The remaining 1/3 will exhibit:
-jaundice
-dark urine
-fatigue
-anorexia
-abdominal pain
-nausea
-skin rash
-fever
* Symptoms of HIV Infected Individuals
(Please note that HIV is a virus and AIDS is a disease)
Clinical indicators of HIV infection:
-fever
-diarrhea
-fatigue
-rash
-lymphadenopathy
Clinical indicators of AIDS:
-pneumocystosis pneumonia
-Kaposi's sarcoma
-non-Hodgkin's lymphoma
-esophageal candidiasis
-CD4 + level of under 200
HEPATITIS B VACCINATION
Initial Hepatitis B Vaccination
A. Hepatitis B vaccination must be made available at no cost to all employees who
have occupational exposure.
* The vaccine shall be administered by a physician or other licensed health
care professional.
* The vaccine shall be provided in accordance with current United States
Public Health Service recommendations.
* Vaccination shall be made available after the employee has received the
training described under the tab entitled "Training" and within 10 working
days of initial assignment to tasks involving occupational exposure.
* The vaccination requirement is waived if the employee has previously
received the complete HBV vaccination series, or if antibody testing reveals
that the employee is immune, or if the vaccine is contraindicated for medical
reasons.
If the employee claims to have previously received the vaccination series, the
employer is advised to request such in writing.
* If the employer shall not make pre-screening a pre-requisite for receiving
hepatitis B vaccination.
* If the employee wishes to be evaluated before vaccination, the employer
must obtain the health care professional's written opinion (see section on
health care professional's written opinion) and give it to the employee
within 15 days of its completion. The report should state whether HBV
vaccination is indicated and if vaccination has been received.
* The employer must provide a copy of the OSHA Standard to the health care
professional who will evaluate the employee and/or administer the vaccine.
* Such vaccination series requirements apply to part-time, temporary and
probationary employees.
B. If the employee initially declines hepatitis B vaccination, the employer must
still make the vaccine available, at no cost to the employee, provided:
* The employee is still covered under the Standard;
* The employee still has occupational exposure.
C. Employees who decline to be vaccinated shall be required to sign the Hepatitis B
Vaccine Declination form.
D. If in the future, U.S. Public Health Service recommends booster doses, the
employer must provide these at no cost.
E. All necessary laboratory tests shall be conducted by an accredited laboratory at no
cost to the employees and this report should be filed in the employee's Medical
Record; findings and diagnoses not pertaining to HBV vaccination must remain
confidential and cannot be included in the written report.
F. Titers to determine immunity after the completion of the series of Hepatitis
injections is recommended.
HEPATITIS B VACCINE DECLINATION
I understand that due to my occupational exposure to blood and 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 Date
______________________________________________________________________________
Employee Name-printed Job Classification
TRAINING
A. GENERAL
* The office/employer shall provide a training program to each of its
employees at the time of initial employment and annually thereafter.
* Additional training will be provided when any modification in tasks or
procedures occurs or following the institution of new tasks or procedures.
* Materials appropriate in content and vocabulary to educational level,
literacy, and language of employees shall be used.
* Documentation
-Complete "Employee Confirmation" and "In-Service Training Checklist"
forms after each training session.
-It is suggested that you initially make copies of the forms for future
completion.
B. THE TRAINING PROGRAM WILL CONTAIN THE FOLLOWING
ELEMENTS:
* An accessible copy of the regulatory text of 29 CFR 1910.1030 and an
explanation of all applicable regulations regarding exposure to occupational
bloodborne disease;
* A general explanation of the epidemiology and symptoms of bloodborne
disease;
* An explanation of the mode of transmission of bloodborne pathogens and
other common microbial pathogens;
* An explanation of the employer's Exposure Control Program and a means
by which employees can obtain a copy of the written plan;
* An explanation of the appropriate methods for recognizing tasks and
potentially infectious materials;
* An explanation of the use and limitations of practices that will prevent or
reduce exposure including, appropriate engineering controls, work
practices, and personal protective equipment;
* Information on the types, proper use, location, removal, handling,
decontamination and/or disposal of personal protective equipment;
* An explanation of the signs and labels and/or color coding that is required
by applicable regulations.
* Posting and availability of emergency phone numbers and emergency
response procedures;
* A detailed explanation of spill containment and spill decontamination
procedures;
* An explanation of the various methods of waste decontamination and
disposal;
* Information on the hepatitis B vaccine, including information on its
efficacy, safety, and the benefits of being vaccinated;
* An explanation on the medical and notification procedures to follow if an
exposure incident occurs, including the method of reporting the incident and
the medical follow-up that will be made available. Also information on the
medical counseling that the employer is providing for exposed individuals.
* An opportunity for interactive questions and answers with the person
conducting the training session.
EMPLOYEE CONFIRMATION
By signing this statement I am stating that I have read and understand the Exposure Control Plan of
the office of
The University of Tennessee, Memphis
(employer)
I am further stating that I shall utilize my best efforts to abide by this Exposure Control Plan.
_____________________________________________________________________________
Employee's signature Witness
_____________________________________________________________________________
Employee's name-printed Date
Person conducting training and
Qualifications:
Date of Training Session:
Persons attending session and job classifications:
RECORD-KEEPING AND DOCUMENTATION
A. MEDICAL RECORDS
* The University will establish and maintain an accurate record for each
employee to include:
-the name and social security number of each employee;
-a copy of each employee's hepatitis B vaccination record or refusal-to-
receive HBV vaccination;
-all records relative to the employee's ability to receive the vaccination;
-all records detailing the circumstances of an exposure incident;
-a copy of all results of physical examinations, medical testing, and follow-
up procedures as they relate to the employee's ability to receive the
vaccination or post-exposure evaluation following an exposure incident;
-the employer's copy of the physician's written opinion, and
-a copy of the information provided to the physician.
* The office shall keep all medical records confidential as required by OSHA.
* These records will be maintained for at least the duration of employment
plus 30 years.
B. TRAINING RECORDS
* Training records will include the following information:
-the dates of the training sessions;
-the contents or summary of the training sessions;
-the names of the persons conducting the training;
-the names of all persons attending the training sessions
* The training records will be maintained by the University for at least three
years from date of training.
C. RECORD AVAILABILITY
* All records will be made available upon request to the Assistant Secretary
and Director of OSHA for examination and copying.
* Employee training records will be provided upon request for examination to
employees, employee representatives, and the Assistant Secretary of
OSHA.
* Employee medical records and training records will be provided upon
request for examination and copying to the subject employee, to anyone
having written consent of the subject employee, and to the Assistant
Secretary of OSHA.
D. TRANSFER OF RECORDS
* The University will comply with the requirements set forth under
29 CFR 1910.20(h) involving the transfer of records.
* If the employer/office ceases to do business and there is no successor, the
University will notify the Director of OSHA at least three months prior to
ceasing business and transmit records if required by the Director of OSHA
to do so during that three month period.
E. IN THIS OFFICE THESE RECORDS/DOCUMENTATION ARE LOCATED AT:
Specific location
Specific location
and maintained by
Name
Name
UNIVERSITY OF TENNESSEE, MEMPHIS
COMMITTEE ON INFECTION CONTROL
PROTOCOL FOR EVALUATION, PROPHYLAXIS AND FOLLOW-UP OF FACULTY,
HOUSESTAFF, OTHER EMPLOYEES AND STUDENTS EXPOSED TO BLOOD BORNE
PATHOGENS (I.E. HIV, VIRAL HEPATITIS)
GENERAL PURPOSE
The purpose of this protocol is to provide a system for evaluation, prophylaxis and follow-up for
faculty, housestaff, other employees and students occupationally exposed to blood borne diseases
(i.e. HIV, Hepatitis B, and Hepatitis non-A, non-B).
I. Exposure to HIV
A. Background
1. Risk of HIV Infection in Health Care Workers and Students
Human Immunodeficiency virus (HIV), the cause of acquired
immunodeficiency syndrome (AIDS), can be transmitted to health care
personnel exposed to blood and other materialscontaining the virus.
The risk of infection following parenteral needlestick exposure to blood
containing HIV is approximately 0.3% (1 in 333 exposures). The risk from
mucous membrane exposure and contamination of non-intact skin with
blood is not zero, but is too low to be measured in the prospective studies of
exposure of health care workers (HCW) published to date. The best
estimate is that the risk of HIV infection after mucous membrane exposure
is less that 3 in one thousand. No risk from contamination of normal skin
or from other types of exposure has been documented. Other factors in
addition to the route of exposure may influence transmission risk, e.g. titer
of virus in the source material, volume of infected material involved,
viability of the virus, etc.
Although few occupationally infected HCWs have so far developed AIDS,
present evidence suggests that infection is likely to be eventually fatal in the
majority. There is no known cure for AIDS; prevention of infection is
therefore of paramount importance.
2. Efficacy of Zidovudine
Zidovudine (AZT) is a drug which delays but does not prevent disease
progression in patients with AIDS. Zidovudine inhibits reverse
transcriptase, a viral enzyme required for replication and development of the
latent state. The efficacy of zidovudine in preventing latent infection with
HIV following occupational exposure is not known and will be difficult to
ascertain because of the low frequency of transmission.
Data derived from animal studies suggest that zidovudine may be at least
partially effective in preventing viremia, disease, and perhaps latent
infection in animals inoculated with non-human retroviruses. Benefit is
most evident when the drug is administered before exposure (pre-exposure
prophylaxis). Drug efficacy decreases when treatment is delayed. Efficacy
of post-exposure prophylaxis in rhesus monkeys inoculated with lower
titers of retrovirus (more comparable to the amount of virus involved in a
typical needlestick injury) has been studied, and no protective effect was
observed.
3. Toxicity of Zidovudine
Evaluation of toxicity from zidovudine in healthy HCWs treated for short
intervals is incomplete. Persons with asymptomatic HIV infection rarely
experience serious toxicity in the first 4 weeks of treatment. Headaches,
nausea, diarrhea, fever, insomnia, paresthesias, neutropenia, macrocytic
anemia, thrombocytopenia, hepatitis, myositis, and skin changes may be
side effects of treatment. Irreversible toxicity is unusual even in patients
treated for prolonged intervals. Delayed toxicity, teratogenicity, and
mutagenicity have not been evaluated.
4. Rationale for Administering Zidovudine
The risk of HIV infection after exposure is not high, but the outcome, should
infection occur, is likely to be fatal. Although the risks and benefits from post-
exposure treatment with zidovudine are unknown, some HCWs may choose to take
zidovudine after occupational exposure. The risk/ benefit ratio of post-exposure
prophylaxis is likely to be most apparent for exposure involving a higher risk of
infection ("massive parenteral", "definite parenteral", and "possible parenteral"
exposures).
Toxicity is likely to be related to zidovudine dose and the duration of treatment.
The optimal dosing regimen for zidovudine is unknown, however, current
recommendations for treating patients with established infection are designed to
provide drug levels in excess of the concentration required to inhibit HIV replication
in tissue cultures (> 1 uM). The duration of treatment required to protect against
infection after exposure is unknown, and cannot be predicted from data currently
available. Experience with non-retroviral viruses suggests that prophylactic
treatment for more than a few days is not usually required, but the relevance of
these data to HIV is unclear.
This protocol is designed to provide a consistent approach to treating HCWs and
students occupationally exposed to HIV with zidovudine. The dose will be 200 mg
6 times a day for 3 days followed by 200 mg five times a day for 25 days.
B. Eligible Health Care Workers and Students
1. Definition of Health Care Workers
a. Faculty
b. Housestaff
c. Employees
2. Definition of Students
Any individual presently registered at the University of Tennessee,
Memphis or a student registered at another university on an elective
approved by the University of Tennessee, Memphis.
3. Eligibility Criteria
A health care worker or student with a discrete occupational exposure to
HIV infective material four or fewer days before presentation to a treatment
site is eligible for prophylaxis. HCWs or students receiving zidovudine
therapy in the past may be treated again if:
a)greater than 3 months has elapsed since the completion of the previous
course, and
b)no more than 2 prior courses of treatment have been given. HCWs or
students sustaining exposures more than four days before evaluation may be
treated at the discretion of the Supervising Physician or his/her designee.
a. Eligible exposures
1)"Massive parenteral" exposure: zidovudine should be
offered.
a) Transfusion of blood.
b) Injection of large volume of blood or
infectious body fluids (> 1 ml).
c)Parenteral exposure to laboratory specimens
containing high titer of virus.
2)"Definite parenteral" exposure: zidovudine should be
offered.
a)Intramuscular (IM/"deep") injury with a
blood/bloody body fluid- contaminated needle.
b)Injection of blood/bloody body fluid not included
in I, B, 3, a, 1).
c)Laceration or similar wounds produced by a visibly
blood/bloody body fluid - contaminated instrument
which causes bleeding.
d)Laceration or similar fresh wound inoculated with
blood/bloody body fluid.
e)Any inoculation with HIV virus (usually research
settings) not included in I, B, 3, a, 1).
3) "Possible parenteral" exposure: zidovudine
should be offered.
a)Subcutaneous (SQ/"superficial") injury by
blood/bloody body fluid - contaminated needle.
b)A superficial wound produced by blood/bloody
body fluid - contaminated instrument which does not
cause visible bleeding.
c)Prior wound or skin lesion contaminated with
blood/bloody body fluids.
d)Mucous membrane inoculation with blood/bloody
body fluids.
4)"Doubtful parenteral" exposure: zidovudine should not be
offered but can be prescribed in selected cases; HCW should
be advised of the extremely small risk of infection associated
with this type of exposure.
a)Subcutaneous (SQ/"superficial") injury with non-
bloody body fluid - contaminated needle.
b)A superficial wound produced by non-bloody
body fluid - contaminated instrument which does not
cause visible bleeding.
c)Prior wound or skin lesion contaminated with non-
bloody body fluids.
d)Mucous membrane inoculation with non-bloody
body fluid.
5)"Non-parenteral" exposure: zidovudine should not be
prescribed.
a)Intact skin visibly contaminated with blood/bloody
body fluid/non-bloody body fluid
b. HIV infected material: body fluids/tissues*
1) Blood
2) Blood products
3) Bloody body fluids
4) Menstrual discharge
5) Semen
6) Breast Milk
7) Saliva
8) CSF
9) Amniotic fluid
10) Pleural fluid
11) Peritoneal fluid
12) Pericardial fluid
13) Synovial fluid
14) Tears
15) Inflammatory exudates
16) Any body tissue
* Although infectivity is known to decrease with the age of the
specimen, all should be considered potentially infectious, regardless
of age.
c.HIV infection documented in the source whether or not the source is a
patient being treated with zidovudine, and source fluid has not been
physically or chemically inactivated (one or more of the following criteria):
1)Clinically diagnosed AIDS or AIDS Related Complex (ARC) or
compatible symptoms/signs in patient at high risk.
2)Repeatedly reactive ELISA in source serum confirmed by Western
Blot or IFA.
3)p24 antigenemia in source serum.
4)Positive HIV culture from any site in source.
5)Positive polymerase chain reaction in source.
6)Fluids or tissues contaminated with HIV in research laboratories
regardless of age of the specimen.
d.An HCW or student who has been exposed to the blood or body fluids of
a patient at high risk for HIV infection may be started on prophylaxis
immediately pending the results of an HIV test on the source patient.
e.HCW must provide informed consent to receive an approved drug for a
non-approved indication.
4. Exclusion Criteria
a.HCWs or students sustaining "non-parenteral" exposures.
b.Men or women of child-bearing capacity, who decline to perform
acceptable contraception or abstinence during the period of
chemoprophylaxis and for four weeks thereafter.
c.Women who are pregnant or become pregnant and who elect to continue
pregnancy.
d.Women who elect to continue breastfeeding during the period of
treatment.
e.Persons who refuse to give consent.
f.Prior diagnosis of HIV infection; zidovudine should be discontinued if
baseline HIV tests are found to be positive after treatment is begun.
g.Underlying renal insufficiency (creatinine greater than 3 times normal).
h.Underlying hepatic insufficiency (SGOT, alkaline phosphatase, or total
bilirubin greater than 3 times normal).
i.Endogenous or drug-induced immunosuppression.
j.Bone marrow dysfunction (Hgb < 10 g/dl); granulocytes < 1500/mm3, or
platelets < 100,000/mm3).
k.Treatment with myelosuppressive/nephrotoxic/ hepatotoxic drugs within 2
weeks prior to or concurrent with starting therapy.
C. Treatment Procedures
1. Source Patient Evaluation
When the source of the exposure is known and HIV infection has not been
diagnosed, the source patient will be tested for HIV antibody in accordance with the
institutional policy of each treatment site. The results of this evaluation will be
disclosed to the exposed HCW and the treating clinicians.
2. Informed Consent
Following a discussion of the potential risks and benefits of prophylaxis with
zidovudine (Appendix A) with the Supervising Physician or his/her designee,
employees or students choosing to receive zidovudine must read and sign the
consent form (Appendix B). Individuals of child-bearing potential must also sign
the statement of intent to avoid pregnancy (Appendix C). To facilitate
implementation of therapy as soon as possible after exposure, a limited number of
doses of zidovudine may be provided after verbal (telephone) consent, to cover any
period of time that the designated treatment site is closed, provided the HCW agrees
to report to the designated treatment site on the first regular business day after
exposure.
3. Initial Laboratory Evaluation
a. Routine Laboratory Studies
1)Complete blood count including differential and platelet counts
2)Urinalysis with microscopic exam
3)SGOT
4)Alkaline phosphatase
5)Total bilirubin
6)Serum creatinine
7)CPK
8)Pregnancy test (serum or urine)
b.Tests for antibody to HIV
1)HIV antibody (ELISA)
2)Confirmatory test (WB or IFA)
4. Medication Instructions
a.The person to receive prophylaxis should be given a two week supply of
zidovudine and instructed to take two capsules (200 mg) every 4 hours, six
times a day, for 3 days followed by 200 mg five times a day for 25 days. A
convenient regimen is two capsules at 7 a.m., 11 a.m., 3 p.m., 7 p.m., 11
p.m., and 3 a.m. for the first 3 days with omission of the 3 a.m. dose for
the next 25 days. A second two week supply will be provided at the time of
the two week follow-up visit, provided no adverse effects requiring drug
discontinuation or dosage adjustments are apparent.
b.Written instructions for taking zidovudine and a review of potential
adverse effects warranting medical evaluation will be provided to each
HCW or student (Appendix D). A physician will be available 24 hours a
day at each treatment site with whom the person on call may consult when
questions arise about application of this protocol for evaluation and
prophylaxis of persons exposed to blood and body fluids.
D. Follow-up
1.Each treated person should be evaluated by the designated treatment site (faculty
and housestaff) or University Health Services (UHS) (students) at 2 weeks, 4
weeks, and 6 weeks. The above routine laboratory studies will be repeated at each
visit. Repeat tests for HIV antibody will be done at 6 weeks, 3 months, and 6
months, and 12 months after therapy is started.
The Medical Record will be updated at each visit. Potential side effects will be
evaluated and physical exam performed as indicated by symptoms. Zidovudine
treatment will be reduced or discontinued if indicated by the occurrence of side
effects. Life-threatening complications (or deaths) occurring in persons receiving
zidovudine will be reported promptly to the Food and Drug Administration.
II. EXPOSURE TO VIRAL HEPATITIS
A. Background
1.Risk of Viral Hepatitis Infections in Health Care Workers and Students
Hepatitis A is very rarely transmitted by blood or blood products, because viremia
is shortlived and there is no carrier state.
Hepatitis B is transmitted by apparent or inapparent exposure to blood, blood
products, and certain body fluids and by transplanted tissues. Other than blood and
blood products, body fluids that have been implicated in transmission of hepatitis B
are semen, vaginal fluids, breast milk and probably saliva. Types of exposures
include needlestick, laceration with a sharp object, contamination of a break in the
skin and direct or indirect inoculation of mucous membranes. After a needlestick
exposure to infectious blood, between 6% and 30% of susceptible persons will
develop hepatitis B. Approximately 1 in 1000 patients with hepatitis B die of
fulminant infection. 5% of patients become long-term carriers with varying degrees
of liver disease.
Most non-A, non-B hepatitis in the United States is caused by Hepatitis C (1).
There are probably one or more other causal agents of non-A, non-B hepatitis. The
mode of transmission of hepatitis C and other non-A, non-B hepatitis viruses is
similar to that of hepatitis B, i.e. by blood and blood products and perhaps by other
body fluids. Although not well defined, non-A, non-B hepatitis viruses can be
transmitted to health care workers by parenteral exposure (2,3). The risk of
transmission after needlestick exposure to a patient with non-A, non-B hepatitis or
hepatitis C is unknown.
2. Efficacy of Prophylaxis Against Viral Hepatitis
The prophylaxis of choice for hepatitis B is immunization with hepatitis B vaccine
prior to exposure. This provides essentially 100% protection for those who
develop detectable antibodies. For post-exposure prophylaxis, the first dose of
vaccine should be administered together with hepatitis B immune globulin
immediately after exposure. This should be followed by the second and third doses
of vaccine at 1 month and 6 months, respectively. This prophylaxis provides about
95% protection.
Data on post-exposure prophylaxis for non-A, non-B hepatitis are conflicting.
Immune globulin is the prophylactic agent of choice.
B. Eligible Health Care Workers, Other Employees and Students
1. Eligibility Criteria
A HCW, other employee or student with a discrete occupational exposure to HBV,
or non-A, non-B hepatitis viruses seven or fewer days before presentation to the
designated treatment site is eligible for prophylaxis.
a.Eligible Exposures
A susceptible health care worker or student with a parenteral exposure or
possible parenteral exposure as defined above in I, B, 3, a, 1)-4) will be
offered prophylaxis for viral hepatitis.
b.Body fluids infectious for hepatitis viruses
1) HBV
a) Blood
b) Blood products
c) Bloody body fluids
d) Semen
e) Menstrual discharge
f) Breast milk
g) Amniotic fluid
h) Pleural fluid
i) Peritoneal fluid
j) Pericardial fluid
k) Synovial fluid
l) Tears
m) Saliva
n) Inflammatory exudates
o) Any body tissue
2) Non-A, non-B hepatitis viruses
a) Blood
b) Blood products
c) Bloody body fluids
d) Probably other body fluids but no data are available
for other body fluids
c. Viral hepatitis documented in the source or source patient at high
risk and cannot be tested for hepatitis.
1) HBV - HBsAg test positive
2) Non-A, non-B hepatitis viruses
a)Liver function test evidence of hepatitis
b)HAV and HBV tests negative
c)Epidemiologic evidence of exposure to non-A, non-B
hepatitis
d)Other causes of hepatitis ruled out
2. Exclusion Criteria
a. HCWs or students sustaining "non-parenteral" exposures
b. Evidence of prior infection with the hepatitis virus to which the
HCW or student was exposed.
c. History of vaccination with hepatitis B vaccine with serologic
evidence of a protective antibody response (only for those persons
exposed to hepatitis B).
C. Treatment Procedures
1. Source Patient Evaluation
a. When the source of the exposure is known and is available for
testing, an HBsAg test should be done on source blood.
b. When the source of the exposure is known, but is not available for
testing, an attempt should be made to collect the following
information about the source.
1)Results of previous tests for hepatitis B.
2)History of hepatitis B.
3)High risk activities such as being a male homosexual or an IV
drug abuser.
4)History of transfusion with blood or blood products.
2. Initial Laboratory Evaluation of the Exposed HCW, Other Employee or
Student
a. HCW, other employee or student has not been vaccinated
1)Anti-HBc
2)Order an HBsAg test only if the anti-HBc test is positive
b. HCW, other employee or student has been vaccinated
1)If the HCW or student was tested post-vaccination and an
adequate level of anti-HBs was demonstrated in the past 24 months,
no test is needed.
2)If not tested post-vaccination or if the last test was done more than
24 months ago, order an anti-HBs test.
3. Prophylaxis Instructions
a. Source of exposure HBsAg - positive
1)Exposed person has not been vaccinated and has no serologic
markers for past or present HBV infection
a)Single dose of HBIG (0.06 ml/kg) IM given as
soon as possible after the exposure.
b)First dose of hepatitis B vaccine should be given
intramuscularly in the deltoid as soon as possible after the
exposure.
c)Subsequent doses of vaccine should be given as
recommended for that vaccine.
2) Exposed person has begun but not completed vaccination
a)Single dose of HBIG (0.06 ml/kg) IM given as
soon as possible after the exposure.
b)Complete vaccination as scheduled
3) Exposed person has been vaccinated
a)If anti-HBs level is adequate, no treatment
is needed.
b)If anti-HBs level is inadequate, a booster dose of hepatitis
B vaccine should be given as soon as possible after the
exposure.
c)If the person is known not to have responded to the
primary vaccine series, a single dose of HBIG (0.06 ml/kg)
IM and a dose of hepatitis B vaccine should be given as soon
as possible after the exposure.
d)If the person is known not to have responded to the
primary vaccine series plus one booster dose of vaccine, one
dose of HBIG (0.06 ml/kg) IM should be given as soon as
possible after exposure followed by a second dose of HBIG
(0.06 ml/kg) IM one month later.
b. Source of exposure HBsAg-negative
1)If the exposed person has not been vaccinated, the first dose of
hepatitis B vaccine should be given as soon as possible after the
exposure and vaccination should be completed as recommended.
2)If the exposed person has not completed vaccination, vaccination
should be completed as scheduled.
3)If the exposed person has already been vaccinated against hepatitis
B, no treatment is necessary.
c. Source of exposure not available for testing
1)If the exposed person has not been vaccinated, the first dose of
hepatitis B vaccine should be given as soon as possible after the
exposure and vaccination completed as recommended.
2)If the exposed person has begun but not completed vaccination,
vaccination should be completed as scheduled.
3)If the exposed person has been vaccinated and an adequate anti-
HBs response documented, no treatment is needed.
4)If the exposed person has been vaccinated but has inadequate anti-
HBs, a standard booster dose of vaccine should be given.
5)If the exposed person is known not to have responded to the
primary vaccine series and the source is known to be at high risk of
HBV infection, one dose of HBIG (0.06 ml/kg) IM and one dose of
vaccine should be given as soon as possible after exposure.
6)If the exposed person is known not to have responded to the
primary vaccine series plus one booster dose of vaccine, and the
source is known to be at high risk of HBV infection, one dose of
HBIG (0.06 ml/kg) IM should be given as soon as possible after the
exposure followed by a second dose of HBIG (0.06 ml/kg) IM one
month later
d. Source of exposure has non-A, non-B hepatitis as a diagnosis by
exclusion.
1)If the exposed person has received HBIG for exposure to hepatitis
B, no further treatment is needed.
2)If the exposed person has not received HBIG, give Immune
Globulin (0.06 ml/kg) IM as soon as possible after the exposure.
III. EVALUATION, PROPHYLAXIS, FOLLOW-UP AND
DOCUMENTATION
A. For faculty and housestaff, these functions will be the responsibility of the
designated personnel at each treatment site.
B. For faculty and housestaff, prophylaxis and complete follow up for each exposure
incident will be carried out at the treatment site designated for the location at which
the exposure occurred.
C. For students assigned to one of the affiliated hospitals, evaluation and initiation of
prophylaxis will be done by the designated treatment site for the institution where
the exposure took place. Further prophylaxis and follow up for these students will
be done at the UHS. Students not assigned to an affiliated hospital will be seen at
the UHS for evaluation, prophylaxis and follow up of exposures.
D. Employees other than faculty and housestaff (employees in the Pauline, Coleman
and Dunn Buildings) will report to the UHS for evaluation, prophylaxis and follow
up of exposures.
E. The central repository for completed records of all faculty, houseofficers,
employees and students will be the University Health Services.
F. A physician will be available 24 hours a day for consultation at each treatment site.
G. Protocol for management of exposures
1. All faculty, housestaff, employees and students will be given an information
sheet on AZT prophylaxis (Appendix A) and a card (Appendix E) with the
phone number and location of all treatment sites and a phone number for
each treatment site for exposures that occur after hours.
2. After sustaining an exposure or a possible exposure, faculty, houseofficers,
employees and students will report to the designated treatment site or contact
the designated person on call by telephone for exposures sustained after
hours, on the weekends or on holidays.
3. Exposures during hours
a. Each exposure will be evaluated following the common format
described in this protocol (see Appendixes FI and FII for flow
charts).
b. All information about the exposure incident will be recorded on a
standard form (Appendix G) and copies sent to UHS.
c. Source patient evaluation
1)If the source patient is not already known to be infected with HIV
or viral hepatitis, the patient will be tested for antibody to HIV and
for HBsAg in accordance with the institutional policy of each
treatment site.
2)Where possible, these results will be used to determine whether or
not an exposee needs prophylaxis and/or follow up.
d. Treatment Sites
1) Personnel at each treatment site will initiate the appropriate
prophylaxis and baseline and follow up laboratory tests.
2) Prophylaxis will be documented using a standard form
(Appendix H) and all clinical data and laboratory test results
will be recorded on a standard form (Appendix I).
3) Exposure to HIV
a)A baseline test will be done for HIV antibody and the
exposee will be informed about the schedule for follow up
testing.
b)The exposee will be counseled about how to avoid
transmission of HIV to others during the period of time they
may be going through an incubation period (Appendix J).
c)If the following criteria are met, the exposee will be
offered AZT prophylaxis.
(1)"Massive parenteral", "definite parenteral" or
"possible parenteral" exposure.
(2)Greater than 3 months have elapsed since the last
course of AZT.
(3)Exposee has had no more than two prior courses
of AZT.
(4)Females must not be pregnant or breast feeding.
(5)Exposee is not being treated
with myelosuppressive, nephrotoxic or hepatotoxic
drugs and has none of the underlying diseases that
contraindicate prophylaxis with AZT.
d)If the exposee meets the above criteria for AZT
prophylaxis, the theoretical benefits and risks and known
risks of AZT prophylaxis will be explained to the exposee
(Appendix A).
e)If the exposed person elects AZT prophylaxis they will be
asked to sign a consent form (Appendix B) and A Statement
of Intent to Avoid Pregnancy form (Appendix C).
f)The person who elects to receive AZT prophylaxis will
have baseline laboratory tests performed (see I, C, 3. Initial
Laboratory Evaluation on page 8).
g)The exposed person will be given a prescription for AZT.
h)The exposed person will be given an information sheet on
AZT dosing and side effects (Appendix D).
i)The person on AZT prophylaxis will be told to return to
Employee Health or other personnel health care location if
they have any symptoms suggestive of side effects from
AZT, and they will be given an appointment for their first
follow up visit.
4) Exposure to hepatitis B
a)HCWs, faculty, employees, or students who have not
been vaccinated should have the following serologic tests for
hepatitis B
(1) HBsAg
(2) Anti-HBc
b)Faculty person, houseofficer, employee, or student
vaccinated and a post-vaccination anti-HBs test in the past 2
years demonstrated a protective level of antibody.
No test indicated
c)Faculty person, houseofficer, employee, or student
vaccinated but no anti-HBs test done post-vaccination or in
the past 2 years.
Anti-HBs
d)Source of exposure HBsAg-positive
(1)Exposed person not vaccinated, and has no
serologic markers for past or present HBV infection.
(a)Single dose of HBIG (0.06 ml/kg) IM
given as soon as possible after the exposure.
(b)First dose of hepatitis B vaccine should be
given intramuscularly in the deltoid as soon
as possible after the exposure.
(c)Subsequent doses of vaccine should be
given as recommended for that vaccine.
(2)Exposed person has begun but not completed
vaccination.
(a)Single dose of HBIG (0.06 ml/kg) IM
given as soon as possible after the exposure.
(b)Complete vaccination as scheduled.
(3)Exposed person has been vaccinated
(a)If anti-HBs level is adequate, no treatment
is needed.
(b)If anti-HBs level is inadequate, a booster
dose of hepatitis B vaccine should be given
as soon as possible after the exposure.
(c)If the person is known not to have
responded to the primary vaccine series, a
single dose of HBIG (0.06 ml/kg) IM and a
dose of hepatitis B vaccine should be given
as soon as possible after the exposure.
(d)If the person is known not to have
responded to the primary vaccine series plus
one booster dose of vaccine, one dose of
HBIG (0.06 ml/kg) IM should be given as
soon as possible after exposure followed by a
second dose of HBIG (0.06 ml/kg) IM one
month later.
e)Source of exposure HBsAg-negative
(1)If the exposed person has not been vaccinated, the
first dose of hepatitis B vaccine should be given as
soon as possible after the exposure and vaccination
should be completed as recommended.
(2)If the exposed person has not completed
vaccination, vaccination should be completed as
scheduled.
(3)If the exposed person has already been vaccinated
against hepatitis B, no treatment is necessary.
f)Source of exposure not available for testing
(1)If the exposed person has not been vaccinated, the
first dose of hepatitis B vaccine should be given
within 7 days of exposure. Vaccination should be
completed as recommended.
(2)If the exposed person has begun but not
completed vaccination, vaccination should be
completed as scheduled.
(3)If the exposed person has been vaccinated and an
adequate anti-HBs response documented, no
treatment is needed.
(4)If the exposed person has been vaccinated but has
inadequate anti-HBs, a standard booster dose of
vaccine should be given.
(5)If the exposed person is known not to have
responded to the primary vaccine series and the
source is known to be at high risk of HBV infection,
one dose of HBIG (0.06 ml/kg) IM and one dose of
vaccine should be given as soon as possible after
exposure.
(6)If the exposed person is known not to have
responded to the primary vaccine series plus one
booster dose of vaccine, and the source is known to
be at high risk of HBV infection, one dose of HBIG
(0.06 ml/kg) IM should be given as soon as possible
after the exposure followed by a second dose of
HBIG (0.06 ml/kg) IM one month later.
g)Source of exposure has non-A, non-B hepatitis as a
diagnosis by exclusion.
(1)If the exposed person has received HBIG for
exposure to hepatitis B, no further treatment is
needed.
(2)If the exposed person has not received HBIG,
give Immune Globulin (0.06 ml/kg) IM as soon as
possible after the exposure.
h)Serologic follow up of persons given prophylaxis for
exposure to viral hepatitis.
(1)Hepatitis B
(a)Persons given vaccine and HBIG should
have an HBsAg at 6 months.
(b)Persons who received 2 doses of HBIG
and no vaccine should have an HBsAg at 9
months.
(c)Persons who received only 3 doses of
vaccine should have an anti-HBs taken at
least 4 weeks after the third dose.
(2)Non-A, Non-B hepatitis - Liver function tests
should be done at 6 weeks, 3 months, and 6 months.
d. When evaluation prophylaxis and follow up have been completed
for each exposee, all records will be sent to the UHS and copies of
the records retained by the treatment site.
4. Exposures after hours, on weekends, and on holidays
a. All exposures to blood and body fluids will be reported to the
person on call at the treatment site designated for coverage of the
area where the exposure took place (refer to card for telephone
numbers, Appendix E).
b. The person on call will evaluate each exposure following the
common protocol ( see Appendices FI and FII for flow charts).
c. All information about the exposure incident will be recorded on a
standard form (Appendix G) and copies sent to UHS.
d. If the source patient does not already have serologic or other
documentation of infection with HIV or hepatitis B, the person on
call will ask the exposee to order tests for HIV antibody and/or
HBsAg on the source patient. (Students will ask physicians with
whom they work to order these tests.)
e. If the source patient is known to be HIV antibody positive or is at
high risk of HIV infection, and the exposee has had an exposure that
meets one of the criteria for AZT prophylaxis, the person on call will
offer the exposee zidovudine (AZT) and will offer to explain the
theoretical benefits and risks and known risks of AZT to the exposee
using the information sheet on AZT (Appendix A).
f. To be eligible for AZT prophylaxis, the exposee must also meet
these additional criteria:
1)Greater than 3 months must have elapsed since his/her last course
of AZT.
2)He/She must not have received more than two prior courses of
AZT.
3)Female exposees must be certain that they are not pregnant.
g. If the exposee is eligible for AZT prophylaxis and elects to take
AZT, they will be asked to agree to the following:
1)They must give verbal consent to receive an FDA approved drug
for a nonapproved indication.
2)They must agree to sign a consent form to receive an FDA
approved drug for a nonapproved indication at their designated
treatment site on the next regular business day.
3)They must agree to sign a statement of Intent to Avoid Pregnancy
form at their designated treatment site on the next regular business
day.
4)They must agree to report to their designated treatment site on the
next regular business day for a baseline examination and tests, for a
prescription for the first two weeks of prophylaxis, for further
counseling on safe sexual practices, possible side effects of AZT,
proper dosing of AZT and a follow up appointment at 2 weeks.
h. If the person on call has any difficulty interpreting or applying the
protocol for AZT prophylaxis for any given exposee, they should
seek consultation with the physician on call for that treatment site.
i. If the exposee meets the exposure and eligibility criteria for AZT
prophylaxis, gives verbal consent, agrees to give signed consent,
agrees to sign a statement of Intent to Avoid Pregnancy and agrees
to the baseline studies and follow up protocol for AZT prophylaxis,
the person on call will call the pharmacy for that treatment site and
release enough doses of AZT to cover the dosing regimen for the
exposee until the next regular business day for the Employee Health
Service or other personnel health care location at that treatment site.
j. The person on call will explain the dosage regimen for AZT to the
exposee.
k. The pharmacy will provide a sheet (Appendix D) explaining the
dosage regimen and the side effects when the exposee picks up the
AZT at the pharmacy.
l. The person on call will emphasize the importance of starting the
AZT prophylaxis as soon as possible.
m. Whether or not the exposee elects to take AZT, the person on call
will counsel the exposee about safe sex (Appendix J) and ask the
exposee to report to the Employee Health Service or other personnel
health care location for that treatment site on the next regular
business day.
n. If the source patient does not already have serologic documentation
of hepatitis B infection, the exposee will be asked to order these
tests for the source patient. (Students will ask a physician with
whom they work to order these tests.)
o. If the exposee has had an exposure to a patient positive for HBsAg,
and has no history of having had hepatitis B, no history of a positive
serologic test for hepatitis B, and has not been vaccinated against
hepatitis B, the person on call will ask the exposee to report to the
emergency room for that treatment site for the following:
1)Serologic tests for HBsAg and anti-HBc.
2)One dose of hepatitis B vaccine IM in the deltoid
muscle.
3)HBIG (0.06 ml/kg) IM.
p. Persons, who have been exposed or may have been exposed to viral
hepatitis, will be asked to report to the Employee Health Service or
other personnel health care location for that treatment site if they are
faculty members or housestaff and to the University Health Service
if they are students on the next regular business day whether or not
they were sent to the Emergency Room for prophylaxis.
q. All records initiated by the person on call will be hand carried to the
Employee Health Service or other personnel health care location for
that treatment site and sent to the University Health Services at the
beginning of the next regular business day.
r. When exposees report to the Employee Health Service or other
personnel health care location for a given treatment site, or the
University Health Services after triage and prophylaxis by the
person on call, they will be treated and followed up just as if they
had been seen initially during regular working hours.
REFERENCES
1.Alter MJ, Hadler SC, Judson FN, et al: Risk factors for acute non-A, non-B hepatitis in the
United States and association with hepatitis C virus infection. JAMA 1990;264: 2231-2235.
2.Alter MJ, Berety RJ, Smallwood LA, et al: Sporadic non-A, non-B hepatitis: frequency and
epidemiology in an urban U.S. population. J Infect Dis 1982;145:886-893.
3.Ahtone J, Francis D, Bradley D, Maynard J: Non-A, non-B hepatitis in a nurse after
percutaneous needle exposure. Lancet 1980;1:1142.
4.Centers for Disease Control. Protection against viral hepatitis: recommendations of the
Immunization Practices Advisory Committee (ACIP). MMWR 1990;39(No. RR-2).
5.Centers for Disease Control. Public Health Service Statement on management of occupational
exposure to human immunodeficiency virus, including considerations regarding zidovudine
postexposure use. MMWR 1990;39(No. RR-1):1-11.
6.Rhame F. Needlestick or other significant exposure to blood or other body fluids. University
of Minnesota Hospitals, February, 1990.
7.Craven, D. AZT prophylaxis for employees exposed to HIV. Department of Health and
Hospitals, City of Boston, November 1, 1990.
8.Henderson, D. Open trial of zidovudine post-exposure chemoprophylaxis in healthcare workers
with occupational exposures to Human Immunodeficiency Virus. The Collaborative
Chemoprophylaxis Study Group. Clinical Center, National Institutes of Health, University
of California San Francisco/ San Francisco General Hospital, Centers for Disease Control, March,
1991.
9.Gerberding JL, Conte JE. Protocol for administering and monitoring zidovudine in health care
workers exposed to HIV. San Francisco General Hospital, The University of California, San
Francisco and the California Consortium for Health Care Workers, 1991.
10.Henderson DK, Fahey BJ, Willy M, Schmitt JM, Carey K, Koziol DE, Lane HC, Fedio J,
Saah AJ: Risk for occupational transmission of Human Immunodeficiency Virus Type I (HIV-1)
associated with clinical exposures. A prospective evaluation. Ann Intern Med 1990;113:740-746.
APPENDIX A
Information Sheet for Health Care Workers on Prophylaxis for Exposure to the Human
Immunodeficiency Virus (HIV)
The purpose of this leaflet is to provide you with information about the use of the drug zidovudine
(or AZT) for treatment of health care workers other employees and students who have been
exposed to blood or blood-containing body fluids from a patient infected with the AIDS virus
(human immunodeficiency virus, HIV). The leaflet will provide you with answers to some of the
most common questions. You should be familiar with this information, in the event you do
become exposed. If you are exposed you may be very upset about the accident and might be less
likely to make an informed decision. We hope you will think about this information now, so that
you will have already formulated a plan in the event of an accidental exposure. We hope that this
information, plus discussion with a counselor at the time of the exposure, will make these
decisions easier for you.
What is the risk of HIV infection following a work-related exposure?
Several studies have tried to measure the risk of HIV infection for health-care workers who have
had an HIV exposure on the job. The best available estimate of the risk of HIV infection following
a single parenteral (needlestick) exposure is 0.3%, or roughly 1 infection for every 333 exposures.
No worker in these studies has developed HIV infection following a mucous membrane exposure
(mouth or eye splash of blood or body fluids). Because no infections have occurred in these
studies following splash-type exposures, we can only supply an educated guess about the highest
level risk that might be present after such an exposure. The best current estimate suggests that the
maximum risk of HIV infection after a splash onto a mucous membrane is likely to be less than
0.3% (that is, fewer that three infections for every thousand exposures). As suggested by the
absence of infections resulting from splash exposures in the studies mentioned above, it seems
quite reasonable to assume that the risk for infection resulting from a single splash exposure is
much less than the risk following a parenteral exposure.
What information suggests that AZT might prevent HIV infection following a work-related
exposure?
AZT works by preventing the HIV virus from replicating (making copies of itself). AZT has been
proven to prolong the lives of AIDS patients and has been shown to have a beneficial effect in
patients with HIV infection who haven't yet developed AIDS. Because of the way the drug
works, AZT is unlikely to prevent HIV infection unless it is given to a patient before the virus
begins to replicate. Several animal studies have demonstrated that when AZT is given immediately
after exposure, the signs and symptoms of infection with some retroviruses (not HIV) are
suppressed. Unfortunately, there is currently no scientific information available about the use of
AZT in preventing occupational HIV infection in health care workers. AZT is, however, the
only drug that has been marketed with proven ability to alter the course of HIV infection. AZT has
failed to prevent infection in two cases that we know of; however, problems exist with both cases.
In one case the HIV-infected blood was given intravenously, instead of through the skin as occurs
with most health care worker injuries. AZT was delayed for 6 hours after exposure in the second
case, and this may have been too late to prevent infection.
What is known about the risks of taking AZT?
AZT has been reasonably well tolerated by people who have taken it; serious toxicities from AZT
have been most often seen in patients with AIDS. The major toxicities seen so far have been drops
in the blood count. Severe anemia (drop in red blood cells), neutropenia (drop in white blood
cells), and thrombocytopenia (drop in platelets) may occur, but usually after the first four weeks of
therapy. These effects have also most often been dose-related; that is, the effects on the blood cells
have been most frequently seen in patients who have taken the highest doses of AZT. It is unlikely
that serious toxicities will occur in otherwise healthy individuals given short, four week courses of
AZT. Other possible side effects include: headache, tiredness, muscle aches, sleeplessness,
nausea, and liver cell damage (drug-related hepatitis). Limited experience with giving AZT to
health care workers suggests that the most common problems are subjective complaints such as
flu-like symptoms, profound tiredness, and trouble sleeping. The risk of long term toxicities, such
as alterations in the genetic material in your cells or development of cancer, remains unknown.
The manufacturer of AZT has recently reported that female rats and mice have an increased risk
of developing certain vaginal tumors. All tumors appeared only in animals receiving very large
doses of AZT (up to 35 times the recommended human dosage) for longer than 18 months.
APPENDIX B
INFORMED CONSENT FOR ZIDOVUDINE (AZT) ADMINISTRATION
The ____________________________________________ Hospital offers zidovudine (AZT
therapy to employees and the faculty, housestaff and students from the University of Tennessee,
Memphis who have a qualifying occupational exposure to the human immunodeficiency virus
(HIV). The intent in administering AZT is to reduce your risk for infection with HIV. AZT has
been shown to extend life and reduce infections in certain patients with both AIDS and
asymptomatic HIV infections. There are, however, insufficient data to recommend whether you
should take AZT for your occupational exposure (chemoprophylaxis). The possible side effects of
this medicine, and the plan for monitoring you for adverse reactions to the medicine and for
evidence of HIV infection are outlined below.
BE SURE TO READ THIS CONSENT FORM CLOSELY AND ASK THE PERSON GIVING
IT TO YOU ANY QUESTIONS THAT YOU MAY HAVE REGARDING THIS PROGRAM.
Data from several studies indicate that the risk for HIV transmission associated with a single
parenteral exposure (needlestick) is approximately 0.3%, or three infections for every 1,000
injuries. No health care worker from these studies has developed HIV infection after a mucous
membrane exposure (mouth or eye splash). The best estimate of the maximal risk following
a mucous membrane exposure is less that 0.3% (fewer than three infections for every 1,000
exposures).
AZT prolongs the lives of patients with AIDS and delays progression of disease in patients with
asymptomatic HIV infection. AZT works by preventing HIV from replicating (making copies of
itself); therefore, taking AZT immediately after an exposure may offer the best likelihood of
preventing HIV infection. Studies of infections in mice and cats caused by retroviruses other than
HIV suggest that AZT may alter the course of these infections (animals given AZT stayed well
longer) when given before or shortly after infection. But there are no published data which offer
direct information on how effective AZT may be in humans in preventing occupational HIV
infection. The manufacturer of AZT recently sponsored a national trial to attempt to evaluate 6
weeks of AZT as prophylaxis after occupational exposures. Although the study was
never completed, toxic side effects were minimal. 49 health care workers took AZT, and the most
common side effects included anemia, nausea and fatigue.
Therefore, investigators postulate that if administration of AZT is started shortly after an exposure
and continued for 4 weeks, infection with HIV may be prevented. The Food and Drug
Administration (FDA) has approved the use of AZT for certain patients with HIV infection. The
FDA has not, however, approved AZT as a treatment to prevent infection following a
recognized exposure; the use of AZT for this purpose is therefore considered investigational. In
addition, there are possible side effects and other risks associated with the use of this drug.
Scientists recognize that AZT has short-term, reversible side effects and possibly may have long-
term side effects that have not yet been discovered. In patients with AIDS, the most common side
effects are: headache, nausea, muscle aches and pain, and anemia. A drop in white blood cells
(neutropenia), a decreased number of platelets (thrombocytopenia), numbness and/or tingling in
the hands and feet, and liver cell damage (drug-related hepatitis) may also occur. Although severe
anemia, neutropenia and thrombocytopenia occur frequently during prolonged therapy, these side
effects occur only rarely during the first four weeks of therapy and have most often been dose-
related. Limited experience with giving AZT to health care workers suggests that the most
common problems are subjective complaints such as flu-like symptoms, profound tiredness, and
trouble sleeping. All of these short-term side effects have stopped when the drug was
discontinued. The risk of long-term AZT toxicity in humans remains unknown. The manufacturer
of AZT has recently reported that both female rats and female mice given from 2 to 35 times
the AZT dose recommended for humans for 18-22 months had an increased risk for developing
either malignant or benign tumors of the vagina. The earliest that a tumor was seen was after 19
months of continuous dosing, and these tumors were seen at the highest dose levels. No other
drug-related tumors were observed in either sex of either rats or mice. Whether AZT can cause
fetal harm in a pregnant woman or can affect reproductive capacity remains unknown.
Because of the possible adverse effects to a developing fetus, and because of the possibility that
AZT would be excreted in breast milk, you must agree not to become pregnant or nurse a baby
while taking AZT and for four weeks afterward. If you develop HIV infection, you could pass it
along to a sexual partner, a developing fetus, or to anyone who came in contact with your
blood (for example, through a blood transfusion or sharing needles). Measures to avoid HIV
transmission are therefore necessary until the possibility of HIV infection has passed. In persons
not taking AZT, this period is believed to be six months, but we do not know for sure. It is
theoretically possible that AZT would not prevent HIV infection, but would merely delay its onset.
Therefore, in those who take AZT, it is necessary to continue these precautionary measures until
one year after exposure. This means that you should avoid pregnancy, practice sexual abstinence,
or use condoms during sexual intercourse, avoid sharing needles with anyone else, and not donate
blood for one year after your exposure, which is six months longer than if you had not taken AZT.
Before you begin treatment, we will perform routine laboratory tests on your blood and urine. If
you have any evidence of a blood disorder, kidney disease, liver disease, pregnancy, or other
condition that may increase the likelihood of side effects, you will be notified immediately to stop
taking AZT and to return all unused medicine. You will also be asked to stop taking AZT if you
become pregnant, if your laboratory tests taken before you start the study show that you are
already infected with HIV, or if the patient to whose body fluid you were exposed is found not to
be HIV-infected.
Treatment consists of 200 mg of AZT by mouth (two 100 mg capsules) every four hours, six times
a day for three days, followed by 200 mg five times a day for 25 more days. The AZT will be
provided free of charge. You will be required to visit, at a minimum, your treatment site at weeks,
2, 4, and 6, and at months 3, 6, and 12 after your exposure. Blood will be taken once (after first 2
weeks) while you are taking AZT, and twice more after you have stopped AZT, to help identify
any side effects. If side effects do occur, the dose of AZT may be lowered. If the side effects do
not disappear, AZT may be stopped. Routine blood tests for HIV antibodies will be done at your
first visit, at 6 weeks, and at months 3, 6, and 12. No more than three tablespoons of blood will
be drawn from you at each visit, and approximately one cup of blood will be drawn from you over
the year following your exposure. Although the risk of serious physical injury associated with
blood drawing is negligible, there may be some pain at the site of entry of the needle, and a small
bruise may develop. In addition, there is a very small risk of your fainting or of infection at the
needle entry site.
Treatment with AZT is voluntary. Even if you choose to start taking this medicine, you may
decide to stop therapy at any time. Within 24 hours of your decision to stop therapy, you must
notify your treatment site. If you elect not to receive AZT now, or choose to stop therapy, it will
neither affect your current position nor any other treatment or follow up you would receive as
a result of this exposure. Your declining of treatment does not compromise whatever benefits may
otherwise be available to you under circumstances where it is demonstrated that infection was
acquired during the performance of your official duties. Every attempt will be made to keep your
records confidential within the limits of the law.
If you are found to be infected with HIV, you will be advised to notify all sexual partners and/or
needle sharing partners of your HIV status. You and your sexual partner(s) will be offered
information and counseling on the test results and how to prevent the spread of the infection. You
should also know that it is necessary to report certain communicable diseases, including
all confirmed HIV infections to the Memphis and Shelby County Health Department as required by
Tennessee law. If you have questions or concerns, or if you experience any adverse effects,
you should contact your treatment site.
I, ________________________________________________ have read this consent form, and
been given the opportunity to ask questions relevant to zidovudine (AZT) prophylaxis, and
AGREE TO TREATMENT WITH AZT. I will contact my treatment site if I experience any
adverse effects or have questions related to this program.
_____________________________________________________________________________
Signature of Person to Receive AZT Prophylaxis Date
_____________________________________________________________________________
Clinician's Signature Date
_____________________________________________________________________________
Witness' Signature Date
APPENDIX C
Statement of Intent to Avoid Pregnancy
FOR WOMEN ONLY: To the best of my knowledge, I am not currently pregnant.
I have had or will have a urine or blood pregnancy test as soon as feasible to
assure that I am not pregnant. Furthermore, I agree to attempt to avoid
pregnancy and breastfeeding while taking AZT and for four weeks thereafter.
FOR MEN AND WOMEN: Should I have sexual relations while I am taking AZT
or four weeks afterward, I agree to employ a form of barrier contraception
that has been approved by my physician. I will immediately contact my
physician if pregnancy is suspected.
Signature of Person to Receive AZT Prophylaxis Date
Clinician's Signature Date
Witness' Signature Date
APPENDIX D
INSTRUCTIONS FOR AZT PROPHYLAXIS
Medication
1.Take two capsules (200 mg) every four hours, six times a day, for three
days followed by two capsules (200 mg) five times a day, for 25 days. A
convenient regimen is two capsules at 7 a.m., 11 a.m., 3 p.m., 7 p.m., 11
p.m., and 3 a.m. for the first 3 days with omission of the 3 a.m. dose for
the next 25 days.
2.AZT should be taken exactly as prescribed. Do not take more capsules or
fewer capsules than prescribed, and do not share medication with anyone
else.
3.If you are late in taking AZT:
a.If late by two hours or less, immediately take the dose you missed
and take the next dose as scheduled.
b.If more than two hours late, skip the missed dose return to the
usual schedule at the next dose. Make a record of the missed dose
and inform your clinician at your next visit. Do not double the next
dose if you miss a dose.
4.Store the medication in a cool, dry place. There is no need to refrigerate
AZT. Keep out of reach of children.
5.Take AZT at least one-half hour before a meal or at least one hour after a
meal.
6.Consult your clinician before taking any other medications, either those
prescribed for you by another physician, or those you can buy without a
prescription.
Scheduled Visits
1.It is very important to keep each scheduled visit. If you must change the
time of your scheduled visit, make sure you have enough AZT to last until
the new appointment.
2.It is also very important to visit your clinician at the scheduled
intervals even after you finish taking AZT. The purpose of these visits is
to insure your safety, as well as to test you for evidence of HIV
infection.
Adverse Effects
1.Side effects of AZT include headache, numbness of extremities, fatigue,
insomnia, sleepiness, loss of appetite, nausea, vomiting, dyspepsia,
muscle or joint pain, diarrhea, fever and rash.
2.Inform your clinician if you experience any of these symptoms or any
other unexplained illness or possible side-effect while you are taking
AZT.
3.Your clinician may decrease your dosage in an attempt to reduce side
effects.
4.Even after you finish taking AZT, it is still important to report any
unexplained illness to your clinician.
Precautions
If you should become infected with HIV, AZT has not been shown to reduce the
risk of transmission of this virus to others through sexual contact or blood
contamination, or to a developing fetus. You should continue appropriate
precautionary measures (using barrier contraception, not sharing needles,
refraining from donating blood, and avoiding pregnancy) to prevent
transmission of HIV to others for one year following your exposure.
APPENDIX E
TREATMENT SITE LOCATIONS FOR EXPOSURES DURING HOURS,
TELEPHONE NUMBERS FOR REPORTING EXPOSURES AFTER HOURS
AND ON WEEKENDS AND HOLIDAYS
TREATMENT SITES
HOSPITAL DURING HOURS AFTER HOURS
BAPTIST HOSPITAL Employee Health Services Emergency
Department
(Medical Center) (920 Building, Suite
724)
BAPTIST HOSPITAL Emergency Department Emergency
Department
(East)
BOWLD HOSPITAL ARA ARA
LEBONHEUR HOSPITAL Employee Health Emergency Room
MED Primary Care Clinic Emergency Room
METHODIST HOSPITAL Emergency Room Emergency Room
ST. FRANCIS HOSPITAL Emergency Room Emergency Room
ST. JUDE'S HOSPITAL Call Infectious Diseases Same
Attending and Infection
Control Officer
VA HOSPITAL Employee Health Emergency
Room
TELEPHONE NUMBERS FOR AFTER HOURS,
WEEKENDS AND HOLIDAYS
BAPTIST HOSPITAL (Medical Center) - 227-5511
BAPTIST HOSPITAL (East) - 766-5100
BOWLD HOSPITAL - 575-8135, then dial 328 (Beeper)
LEBONHEUR HOSPITAL - Call operator for Infection Control person or Infectious Diseases
physician
on call
MED - Digital beeper numbers 576-9203 or 576-9697
METHODIST HOSPITAL - 726-7600 or call operator for Infectious Diseases physician on call
ST. FRANCIS HOSPITAL - 765-2180
ST. JUDE'S HOSPITAL - 522-0485
VA HOSPITAL - 528-8990 extension 5454 (Emergency Room)
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