Office of Environmental Health & Safety
Chemical/Biological Safety Section
Bloodborne Pathogens - Infectious Waste Management
I. Purpose
II. Responsibility
III. Regulated Materials
VI. "Red Bags"
VIII. Chlorination
X. Personal Protective Equipment
XII. Post-Exposure Evaluation & Follow-up
XIII. Training/Recordkeeping
XIV. Hepatitis B Vaccine Declination
| I. PURPOSE |
The purpose of this management program is to eliminate or minimize university
staff and student exposure to blood-borne pathogens and to provide
guidance for the proper management of infectious waste materials.
| II. RESPONSIBILITY |
Principal Investigators shall be responsible for ensuring that employees
are properly trained in accordance with this plan, and that employee work
practices comply with the provisions of this plan. All supplies and equipment
required for implementation of this program (i.e. personal protective equipment,
bleach, Hepatitis B vaccinations) shall be provided to staff members through
departmental funding. Insurance that necessary supplies and equipment are
acquired and provided to laboratory staff shall be the responsibility of
the principle investigator. The Office of Environmental Health & Safety
will assist (upon request) departments or individual laboratories in the
training of employees per the provisions of this program. Restocking of
infectious waste ("red") bags and pick-up of waste-filled red bags shall
be coordinated with University Customer Service (828-9444).
| III. REGULATED MATERIALS |
The Virginia Department of Environmental Quality (DEQ) Medical Waste
Management Regulations designate the following seven classes of "controlled
regulated medical waste":
| 1. | Cultures and stock of microorganisms and biologicals. Discarded cultures, stocks, specimens, vaccines and associated items likely to have been contaminated with organisms likely to be pathogenic to healthy humans. |
| 2. | Blood and blood products. Wastes consisting of human blood products (includes serum, plasma etc.) and items contaminated by human blood. |
| 3. | Tissues and other anatomical waste. Includes all human anatomical wastes and all human tissues, organs, body parts or body fluids. |
| 4. | Sharps materials. Includes all sharps materials likely to be contaminated with pathogen organisms, and all sharps used in patient care and veterinary practice. |
| 5. | Animal carcasses, body parts, bedding and related waste. Applies when animals are intentionally infected (for research purpose) with organisms likely to be pathogenic to healthy humans. |
| 6. | Residues, soils, liquids and other debris - resulting from cleanup of a spill of any regulated waste. |
| 7. | Solid waste contaminated by, or mixed with regulated medical waste. |
Recent unwritten changes to the interpretation of the above listed regulations which have been imposed by DEQ's enforcement division, have forced the university to adopt much more stringent protocols regarding the characterization of infectious waste materials. The VCU current infectious waste protocols listed below reflect OEHS's understanding of the, to date, unpublished interpretations being enforced by DEQ.
VCU Infectious Waste Material List
| 1. | Cultures and stock of microorganisms and biologicals. All discarded cultures, stocks, specimens, vaccines and associated items used in research shall be considered infectious waste material. |
| 2. | Blood and blood products. All wastes consisting of human and animal blood products (includes serum, plasma etc.) and all items contaminated/stained by human or animal blood. |
| 3. | Tissues and other anatomical waste. Includes all human and animal anatomical wastes and all human and animal tissues, organs, body parts and body fluids, and all materials contaminated by contact with tissues and/or related fluids. |
| 4. | Sharps materials. Includes all sharps materials likely to be contaminated with pathogen organisms, and all sharps used in patient care and veterinary practice. Continue current practices. |
| 5. | Animal carcasses, body parts, bedding and related waste. Applies when animals are intentionally infected (for research purpose) with organisms likely to be pathogenic to healthy humans. Continue current practices: noninfected carcasses and body parts to Animal Control for incineration; potentially infectious carcasses, body parts, bedding and waste to be considered infectious waste material. |
| 6. | Residues, soils, liquids and other debris - resulting from cleanup of a spill of any regulated waste. |
| 7. | Solid waste contaminated by, or mixed with regulated medical waste. |
Note: Boxes and packing materials used during the shipping of biohazardous products (blood samples, cultures etc.) are not considered to be infectious waste unless contamination via container leakage is suspected. Biohazard labels on such containers must be defaced with an indelible black marker prior to being placed in recycling bins or being disposed of in the domestic waste stream.
Also note: The above listed VCU interpretations are subject to change.
This document will be amended as needed to ensure that VCU standards regarding
infectious waste handling are in line with federal and state regulations.
VCU employees are encouraged to periodically revisit this site to ensure
that infectious waste protocols are up to date.
| IV. SAFE WORK PRACTICES |
Employees shall utilize standard precautions whenever working with potentially infectious materials. Under standard precautions all blood products, human/animal tissues and other potentially infectious materials are considered infectious regardless of the perceived status of the source animal/individual, and work practices are chosen appropriately under these assumptions.
The following engineering controls and work practices are essential
elements of the infectious waste control program:
| 1. | Employees shall thoroughly wash hands with soap and water immediately
upon the removal of gloves following the performance of tasks involving potentially infectious materials. |
||||||||||||||||
| 2. | Employees shall be familiarized with the location and operation of
eye-wash
stations and safety showers in the event of an exposure incident. All exposure incidents (i.e. needle sticks) must be reported to Employee Health immediately. |
||||||||||||||||
| 3. | University staff who encounter improper handling, staging or disposal of potentially infectious and/or sharps materials shall notify OEHS as soon as possible at 828-4404. | ||||||||||||||||
| 4. | All needles, scalpels, blades, scissors and other items which pose
laceration hazards shall be considered infectious "sharps" materials.
Sharps materials shall be disposed of the following manner:
|
||||||||||||||||
| 5. | Needles and other sharps materials shall not be recapped, bent
or otherwise physically altered except as noted below:
|
||||||||||||||||
| 6. | Breaking and shearing of needles is strictly prohibited. | ||||||||||||||||
| 7. | Non-infectious broken glass shall include all broken glassware which
has not come into contact with potentially infectious agents. These
materials may include such items as: glassware broken during or after cleaning,
glassware broken while containing noninfectious materials (water, buffers
et. al.), broken coffee cups, broken soda bottles etc. Glass pastuer
pipettes, test tubes, flasks and petri dishes which have not come into
contact with potentially infectious agents may also be classified as non-infectious
broken glass, if handled accordingly as detailed below:
|
||||||||||||||||
| 8. | Employees shall never engage in the following activities within work
areas where handling or preparation of materials containing potentially
infectious agents is being conducted:
|
||||||||||||||||
| 9. | Refrigerators utilized for storage of potentially infectious materials shall be clearly labeled with BIOHAZARD and/or INFECTIOUS MATERIAL warnings. Food and drink items shall never be stored within refrigerators used for storage of potentially infectious materials. | ||||||||||||||||
| 10. | Storage and/or consumption of food and beverages shall be restricted from all work areas used for preparation or research activities involving potentially infectious agents (bench tops, counters, cabinets, shelves etc.). Infectious material work areas should be routinely disinfected with 10% bleach solution. For additional information regarding proper disinfection and maintenance of work areas, and spill response, refer to section 5. | ||||||||||||||||
| 11. | Work practices should be carefully reviewed prior to conducting activities which involve the handling of potentially infectious materials. Work practices should be selected which minimize potential employee exposure due to splashing, spraying, splattering or other release infectious materials. When engineering controls alone can not suitably lower exposure risk, utilization of additional personal protective equipment (PPE) is mandated (PPE is detailed in section 10). |
| V. CLEAN-UP OF INFECTIOUS MATERIAL SPILLS |
Level III Biohazardous Materials
Response to spills involving materials suspected to be contaminated by Level III (or greater) Biohazardous Materials shall only be conducted by specially trained and protected personnel. Any spill involving Level III Biohazardous Materials should be reported to OEHS immediately (contact Dr. Ogle at 828-9834).
Spills Involving Level II Biohardous Materials
For clean-up of spills involving Level II (or lower) Biohazardous Materials,
or materials assumed to be infectious (under "standard precautions") OEHS
recommends the use of a 10:1 water to bleach solution (10% bleach solution)
for the clean-up of contaminated surfaces. Spill response kits shall
be maintained in all areas where infectious waste is managed. Each
spill kit shall at a minimum include:
| At least one gallon of premixed 10% bleach solution; | |
| Absorbent materials, such as absorbent pads, vermiculite
or disposable towels, for containing and treating spills; |
|
| Spray/mist bottles for bleach solution application; | |
| A cache of unused "red bags" for receiving waste generated during spill response or for overpacking leaking containers; | |
| Rigid containers for receiving contaminated broken glass and other sharps materials; | |
| Liquid impermeable disposable coveralls, gloves, boots, caps and *protective breathing devices such as N-95 respirators; | |
| Eye protection gear, including splash resistant safety glasses and face shields; | |
| A broom, heavy duty brush and dustpan (for spills involving sharps materials); | |
| Extra clothing to replace contaminated items (scrubs e.g.). |
*All use of respirators must be preapproved by OEHS. For inclusion in the university respiratory protection program and assistance in selection of suitable equipment contact Micheal Miller at 828-2596.
Decontamination should be conducted as soon as possible following incidents
involving the spillage of potentially infectious materials. Large,
nonroutine spills should be reported to OEHS as soon as possible.
If assistance is required, stand by until OEHS staff can arrive on site
to assist with clean-up. Details of recommended spill clean-up procedures
for limited area - small volume incidents are as follows:
| 1. | Evacuate spill area to allow aerosol to settle (5 minutes minimum, greater time may be required depending on nature of the incident); | ||||||||
| 2. | 10% bleach solution may either be applied directly via spray bottle on spill area, or via saturated disposable pads/towels or cloth material. | ||||||||
| 3. | The bleach solution must remain in contact with the spilled material for a minimum of 10 minutes. | ||||||||
| 4. | Don two layers of gloves, and eye protection prior to removing bleach-treated spill and clean-up materials from incident site. | ||||||||
| 5. | Place all waste resulting from clean-up directly into a red bag for disposal. | ||||||||
| 6. | Following removal of bleach-saturated towels, mist spill area again with 10% bleach solution and thoroughly wipe down and clean surfaces until no residual material is visible (used towels should again be placed into red bag for disposal). | ||||||||
| 7. | Tools and equipment contaminated by spillage of potentially infectious materials should also be thoroughly immersed (when possible) or wiped down with 10% bleach solution prior to reuse. | ||||||||
| 8. | When incidents involve broken glass or other sharps materials clean-up
should be conducted entirely through mechanical means:
|
||||||||
| 9. | After the completion of clean-up of surfaces and equipment affected by the spill, personal protective gear used during the clean-up shall be thoroughly disinfected (with 10% bleach solution) prior to being replaced in spill response kit. Disposable items used during cleanup (gloves, paper suits etc.) must be placed in red bag for disposal. Clothing items contaminated during spill or clean-up operation should also be disposed via red bag. | ||||||||
| 10. | Restock spill kit to replace items used during incident response. | ||||||||
| 11. | Empty bleach solution from spray bottle, rinse with tap water (leaving bleach solution in spray bottle may lead to corrosion and failure of pump). | ||||||||
| 12. | Prepare a report detailing the date, location, nature of infectious waste involved and a description of the incident, cleanup procedures and disposal method. Forward one copy of the report to OEHS. |
| VI. RED BAG PROTOCOL |
OSHA and DEQ regulations mandate that generators of regulated medical
(infectious) waste be responsible for proper packaging, labeling and storage
of all regulated medical waste materials. Failure to comply with
these regulations could result in sizable fines and possible loss of infectious
waste disposal privileges. The inability to dispose of infectious
waste would prohibit further research involving infectious agents, which
would be quite detrimental to the university - making it critical that
VCU strive to comply fully with all federal and state regulations.
VCU's official "Red Bag" protocols are summarized below.
| 1. | All bags used for disposal of infectious waste
(as defined in section 6 of this document) must meet the following standards:
|
||||||
| 2. | All waste-filled red bags shall be placed within a rigid container prior to transport off site. VCU typically utilizes a sturdy cardboard box for this purpose. | ||||||
| 3. | The outer layer of any container (red bag, box, sharps vessel, drum
etc.) used for transport of infectious waste materials must bear the following
information and labeling:
|
||||||
| 4. | Red bags shall never be allowed to be overfilled. Prior to placing in box, seal red bag by gathering ends and wrapping tightly with several loops of heavy tape. The resulting seal should be leakproof. | ||||||
| 5. | Free liquids must be placed in sturdy leakproof containers which are highly resistant to breakage prior to being placed within red bag/box units. | ||||||
| 6. | Spill response kits must be maintained in all areas where infectious waste is managed (refer to section 5 for recommended supplies and clean-up procedures). | ||||||
| 7. | All areas used for staging or storage of red bags must have impervious surfaces - never place bags on carpeted or wooden floors! | ||||||
| 8. | Stage and store red bag waste in areas which are not readily accessible to the general public - whenever possible limit access to collection and storage areas to specifically designated personnel. | ||||||
| 9. | Discarded infectious waste may be stored at room temperature for no more than 7 days past generation date that bag is sealed. Storage beyond 7 days shall require refrigeration at 20 to 70 Celsius (350 to 450 Fahrenheit). | ||||||
| 10. | No infectious waste shall be stored on site for more than 30 days past generation date. | ||||||
| 11. | Reusable containers shall be thoroughly disinfected (in accordance with manufacturers directions) prior to reuse. | ||||||
| 12. | Personnel handling red bags shall wear leak-resistant gloves at all times. Hands should be thoroughly scrubbed with soap and water following glove removal. |
Note: Never utilize red bags for the disposal of materials which
are not considered regulated medical waste. ALSO: Never dispose of
used or unused red bags in the regular (municipal) waste stream.
As noted previously red bags must be transported from the facility for
disposal by licensed contractors whose services are coordinated through
the Physical Plant Customer Service Department (828-9444).
| VII. AUTOCLAVING PROCEDURES |
DEQ allows for onsite treatment of medical (infectious) waste through
autoclave sterilization. If all of the DEQ autoclave procedural requirements
are followed, properly treated materials are no longer classified
as regulated medical waste, and may be disposed of as unregulated solid
waste. If the DEQ mandated procedures are not followed in full, however,
VCU may be fined and/or lose all on-site waste treatment privileges.
The DEQ regulations (and university requirements) for onsite treatment
of regulated medical waste are summarized below.
| 1. | Autoclave units shall be operated at the following temperature, pressure
and time regimens:
|
||||||||||||
| 2. | Autoclave units shall be quality controlled at a frequency of no less
than once per month. Each quality control event shall consist of:
|
||||||||||||
| 3. | Logbooks shall be maintained which record the following data for each
autoclave event:
|
||||||||||||
| 4. | Materials treated via autoclaving must be containerized as follows:
|
||||||||||||
| 5. | Immediately upon the completion of the sterilization cycle, to each
orange bag the following label (with requested information provided) shall
be securely fixed:
Download this label(require Adobe Acrobat Reader )
|
| VIII. CHLORINATION |
Although chlorination is not officially recognized by DEQ as a means
of treating regulated medical waste, it has long been considered a safe
and effective sterilization method under standard laboratory practices.
Utilization of chlorination alone as a sterilization method may be acceptable
for several applications involving small material quantities with minimal
infectious properties. In some cases this procedure may actually
be safer and more effective than available alternatives. OEHS grants
approval for the use of chlorination on a case by case basis. Please
contact Mike Elliott (828-4404) of the OEHS Chemical/Biological Safety
Section to discuss methodology, and to determine if chlorination is a viable
sterilization alternative for your laboratory.
| IX. LAUNDRY PROCEDURES |
Lab coats and other garments which become contaminated with blood products
or other potentially infectious materials must be segregated from other
"clean" laundry and stored in red bags until they can be properly decontaminated
or disposed of. The VCU Laundering guidelines are provided below:
| 1. | For all items heavily saturated with blood products or tainted with Level II or above biohazardous materials, disposal via red bag waste stream is strongly advised. |
| 2. | Laundry items contaminated with *minute quantities of blood products
may be disinfected by fully saturating affected areas with 10% bleach solution.
Following a minimum 10 minute soaking period (with 10% bleach solution)
decontaminated garments should be washed in hot water with detergent and
bleach added to cycle.
*"Minute" shall be defined as no more than 3 visible stains of quarter size or less in area. |
| 3. | Laundering of materials contaminated with more than minute quantities of blood products must be performed by specially licensed contracting firms. Arrangement for the services of a laundering contractor is a departmental responsibility. For assistance in retaining a laundering contractor contact University Customer Services at 828-9444. |
| X. PERSONAL PROTECTIVE EQUIPMENT |
Personal protective equipment (PPE) must be utilized whenever engineering controls and work practices alone do not provide ample exposure protection. Principal Investigators shall provide all needed PPE to laboratory staff free of charge. Principle Investigators shall also be responsible for providing training to all laboratory staff which details proper use of PPE. OEHS can assist with PPE training upon departmental or laboratory request.
Selection of PPE shall be based on the anticipated level of exposure to potential blood borne pathogens posed by the laboratory procedure(s) to be performed. Appropriately selected PPE shall protect the employee from contact with potential blood borne pathogens via contact with skin, eyes, mucus membranes and/or through aerosol inhalation under normal conditions throughout the period of exposure risk. Effective PPE should also prevent the clothing of laboratory staffmembers from coming into contact with blood or other potentially infectious materials.
The following PPE items shall be considered the minimum acceptable level of protection and shall be worn during all activities involving potentially infectious agents:
1. Gloves (latex, nitrile or other approved impervious material);
2. Laboratory Coat;
3. Eye Protection (OSHA- approved safety goggles or glasses equipped with splash guards).
Please note that the wearing of clothing which exposes skin on the legs (shorts, short skirts etc.) and feet (sandals, flop-flops etc.) is strictly prohibited within laboratories which handle potentially infectious materials.
Procedures which pose exposure risks that cannot be suitably managed by engineering controls and minimum level PPE (gloves, lab coat and eye protection) shall require the implementation of a higher level of PPE. A listing of some of the more common "high" level PPE utilized within university laboratories and specific functions is provided below:
Respiratory Protection Devices: utilized whenever potential for exposure to bloodborne pathogens via inhalation exists. The use of any respiratory protection device must be preapproved by OEHS. Under the University Respiratory Protection Program, OEHS assists with the selection of suitable respiratory protection devices and provides fit testing and respirator training for all university staff. For additional information visit the OEHS Respiratory Protection Program Web page or contact Mike Miller at 828-2596.
Face Shields: procedures which involve a high potential for splashing and/or spattering of blood or other infectious materials require the use use of a face shield in addition to safety glasses/goggles. The face shield serves to protect the exposed skin of the face and also offers additional eye protection to the wearer.
Disposable clothing: procedures involving high potential for splashing/spattering
of blood or other potentially infectious materials may also necessitate
protection beyond the standard lab coat. Disposal clothing composed
on impervious fabric should be donned to protect underclothing and skin
while conducting such activities.
| XI. HEPATITIS B VACCINATION |
Hepatitis B vaccinations are available, free of charge, to all university staff who are assigned to areas where potential for occupational exposure to the viral pathogen is present. Principle Investigators shall notify staff of the availability of Hepatitis B vaccinations, and shall make all necessary arrangements with VCU Employee Health for providing vaccination services.
Employees who decline the Hepatitis B vaccination shall sign the OSHA required "Hepatitis B Declination Form" (provided in section 14.). Employees who initially decline the Hepatitis B vaccination, but decide at a later date to receive the vaccination shall be provided with the vaccination upon request and no charge.
If a routine booster dose of Hepatitis B vaccine is recommended by the
U.S. Public Health Service at a future date, such booster doses shall be
provided to the employee at no charge.
| XII. POST EXPOSURE EVALUATION & FOLLOW-UP |
All exposure incidents shall be reported, investigated and documented.
Employees shall report exposure incidents to their supervisor immediately.
All potentially exposed staffmembers shall proceed to Employee Health (828-0584)
for medical evaluation as soon as possible. The medical evaluation shall
include the following elements:
| 1. | Documentation of exposure route (skin contact, needle stick etc.); |
| 2. | Description of circumstance under which incident occurred; |
| 3. | The identification and documentation of the source individual (not required if the employer can establish that identification is impossible or prohibited by state or local law); |
| 4. | Collection and testing data of source individual for HBV and HIV serological status; |
| 5. | Post-exposure treatment for the employee, when medically indicated in accordance with the U.S. Public Health Service; |
| 6. | Counseling; |
| 7. | Evaluation of any resulting illness. |
Healthcare professionals evaluating exposed employees will be provided with all of the above-listed information (as available) and shall retain copies of the following documents on site:
1. The University Infectious Waste Management Program (this document);
2. The OSHA Bloodborne Pathogen Regulations (29 CFR 1910.1030).
All laboratory tests required in association to the exposure incident
shall be conducted by accredited laboratories at no cost to affected employee(s).
Employees shall receive a copy of the attending heathcare professional's
written opinion within 15 days of the completion of the exposure evaluation.
| XIII. TRAINING & RECORDKEEPING |
All employees who have the potential for coming into contact with bloodborne pathogens and/or other infectious materials shall be provided with training which fully covers the details of this plan and applicable elements of OSHA 29 CFR 1910.1030. Follow up training shall be conducted on (at minimum) an annual basis after the initial training session. Additional training should also be conducted within individual laboratories prior to initiation of new or modification of existing procedures involving potentially infectious materials.
Training programs shall include the following elements:
| 1. | An accessible copy of this plan and an explanation of it's contents; |
| 2. | An accessible copy of OSHA 29 CFR 1910.1030 and an explanation of it's contents; |
| 3. | A general explanation of the epidemiology and symtomology of diseases associated with bloodborne pathogens; |
| 4. | Discussion of the modes for the transmission of bloodborne pathogens and other infectious materials; |
| 5. | An explanation of the employer's exposure control plan, and a written copy of the plan; |
| 6. | Discussion of methods for identifying tasks which involve the potential for exposure to blood products and other infectious materials; |
| 7. | Detailed information regarding the use and limitations of engineering controls for reducing exposure risks; |
| 8. | Detailed information regarding the use and limitations od personal protective equipment (PPE) for reducing exposure risk; |
| 9. | Hands-on training detailing types, applications, and proper use and care. |
OEHS can assist with the development and implementation of the training
program. For assistance please contact Mike Elliott at 828-4404.
| XIV. HEPATITIS B DECLINATION FORM |
I understand that due to my occupational exposure to blood or other infectious materials that I may be at risk for acquiring Hepatitis B virus infection. I have been given the opportunity to be vaccinated with the Hepatitis B vaccine at no charge to myself. However I decline the 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 exposure to blood or other potentially infectious materials and I want the Hepatitis B vaccine, I can receive the vaccination series at no charge to me.
(print name)-----------------------------------------
(title)------------------------------------------------
(signature)------------------------------------------
(date)--------------------
: 828-4404
| OEHS Home Page | CBSS Home Page | VCU Home Page |