BIOHAZARDS AND RECOMBINANT DNA
Control Practices
Planning and implementation of control practices for the prevention of laboratory acquired infections and for the protection of the general environment are to be included in all research programs involving biohazardous agents and Recombinant DNA.
Definitions
Biohazardous agents are infectious microorganisms, or their toxins, which cause or may cause human disease.
Recombinant DNA is molecules, which are constructed outside living cells by joining natural or synthetic DNA segments to DNA Molecules that can replicate in a living cell, or DNA Molecules that result from the replication.
Applicability
These requirements apply (1) to microorganisms and viruses listed by the CDC/NIH, in Biosafety in Microbiological and Biomedical Laboratories; (2) to DNA Molecules listed in NIH Guidelines for Research Involving Recombinant DNA; and (3) to HIV and HBV as defined in OSHA 1910.1030 "Bloodborne Pathogens".
Registration
Prior to initiation of work with a biohazardous agent, or recombinant DNA the principal investigator is to notify the Safety & Risk Management Office of the agents used and the location of the laboratory. Higher risk (See NIH classes of experiments) recombinant DNA projects will also require review by the Institutional Biosafety Committee (IBC).
Class 3 or 4 Viruses, HIV or HBV
There are no facilities on campus appropriate for working with dangerous class 3 or 4 viruses or for concentrated HIV or HBV so work involving these agents is prohibited
Principal Investigator
Each principal investigator is responsible for assuring that laboratory personnel are trained in safe practices; reporting exposures, potential exposures, to these biohazardous agents to the Safety & Risk Management Office; and submitting a Safety Plan for research under his/her direction to the Safety & Risk Management Office. The Safety Plan is to describe the procedures that will be used to insure the safe handling of biohazardous agents, an assessment of the potential risks, the need for medical surveillance, procedures for handling accidental spills and waste disposal methods. Please contact the Safety & Risk Management Office for templates and guidance.
Grant Applications
Proposed research projects involving biohazardous agents should be reviewed with the Safety & Risk Management Office to ensure that the budget includes consideration of any specialized requirements to insure the safe conduct of the research.
Safety Standards
Recommended safety practices and facilities for the use of biohazardous agents are given in the Biological Safety Manual available from the Center for Disease Control and National Institute of Health, NIH # 88 8395, U. 5. Government Printing Office, Washington, D.C., 20402
Recommended Safety practices for Recombinant DNA research is given in the Guidelines for Research Involving Recombinant DNA, NIH Federal Register May 7, 1986.
Safety Standards for working with HIV or HBV is given in OSHA 1910.1030.
These publications are available in the Safety & Risk Management Office.
BLOODBORNE PATHOGENS
Exposure Determination
The following classifications of employees of the University are at risk of exposure to human body fluids and fall under the Category I exposure control plan described below.
| Clinical Laboratory Science Faculty, Student Laboratory Assistants, Clinical Laboratory Technician: | Phlebotomy, pipetting of body fluids, handling of body fluid specimens, custodial chores of the laboratory, maintenance of instruments. |
| Emergency Medical Care Faculty, Student laboratory Assistants, SECT Team: | Phlebotomy, initiation of intravenous solutions, administration of injections, wound
care and dressings, catheritization, assistance in minor surgery, endotracheal incubation,
assessment of body systems minimal custodial duties. Handling of open wounds in emergency situations, dealing with upset and at time emotionally disturbed individuals in poor control of their actions. |
| Housekeeper (Health Services): | General housekeeping chores, i.e.: cleaning of areas contaminated by body fluids, removal of trash containing bodily fluids in appropriate containers from work areas. |
| Physician/Physician Assistant: | Evaluation of wounds and wound closure; minor surgery, i.e.; incision and drainage of abscesses, and excisional biopsy; pelvic and rectal examinations; sexually transmitted disease screening and evaluation. |
| Physical Therapist (PT) and PT Laboratory Assistant: | Handling of fixed human tissues during dissection, custodial chores of the laboratory, removal of contaminated wastes to be autoclaved, cleaning of instruments used in dissection |
| Registered Nurse: | Administration of injections, wound care and dressing changes, assisting in minor surgery, catherization, administration of enemas and suppositories, cleaning and sterilization of instruments, minimal custodial chores in absence of housekeeper. |
| Athletic Trainer and Assistant: | Handling of open wounds, wound closure, cleaning of areas contaminated with body fluids, cleaning and sterilization of instruments. |
The following classifications of employees are not ordinarily at risk of exposure to human body fluids but could occasionally encounter body fluids and fall under the Category II control plan described below.
| Police Officer: | Dealing with disruptive individuals, crime scene search, cleaning contaminated surfaces of police equipment. |
| Housekeeper: | Picking up trash with unauthorized needles and sharps, cleaning bathrooms or other potentially contaminated areas. |
| Plumbers: | Cleaning out sewer drains, repairing toilets and drain pipes. |
| Developmental Evaluation Personnel: | Working with emotionally disturbed individuals. |
Exposure Control Plan - Category I
Universal precautions shall be observed with all human body fluids. According to the concept of Universal precautions, all human blood and certain body fluids are treated as if known to be infectious for Human Immunodeficiency Virus and Hepatitis B Virus and other bloodborne pathogens.
- Use non-sterile gloves when handling blood, body fluid, secretions or excretions.
- Disposable gloves must be replaced as soon as practical when contaminated.
- Utility gloves may be decontaminated for reuse if the integrity of the glove is not compromised. (See paragraph 4 in this section).
- Gloves will be changed after contact with each patient and before touching environmental surfaces.
- Gowns or lab coats must be worn if soiling of clothes with blood or other body fluids is anticipated. Masks are not necessary. Eyewear is necessary only when splatter of body fluids is anticipated.
- Needles, syringes, and other sharp objects should be disposable and should be disposed of in rigid puncture-resistant, leak-proof containers. Further, needles should not be recapped, nor should they be removed from a disposable syringe because needle stick injuries are most likely to happen during these activities. The use of needle cutting devices is not recommended for needles attached to disposable syringes but may be practical for vacationer systems when on disposable jackets are used or when intravenous sets are withdrawn. All needles shall be considered contaminated. Broken glassware, which may be contaminated, must not be picked up directly with the hands. Use a brush, dustpan, tongs, forceps, etc.
- Instruments, work areas, and non-disposable contaminated with blood or body fluids should be safely decontaminated with 1:10 dilution of 5.25% sodium hypochlorite (bleach) and water or other EPA approved tuberculocidal disinfectants. (e.g., osyl or septicol).
- Reusable containers shall not be handled or cleaned manually.
- Mouth pipetting of all liquids, body fluid or specimens in the laboratory must not be allowed. Mechanical pipetting devices must be used.
- Procedures having a high potential for creating aerosols or infectious droplets (centrifugation, vending, sonicating, vigorous mixing, and harvesting of tissue from animals or embryonated eggs) should be done in a Class II Biological Safety Cabinet (BSC)
- There will be no eating, drinking, applying of lip balm, manipulation of contact lenses, or smoking in laboratory or potential exposure areas. There will be no storage of food in laboratory or work areas.
- At present, commercially obtained laboratory reagents or controls derived from blood products should be treated as potentially contaminated specimens.
- Infectious waste shall be "red bagged" in leak proof containers which are labeled with the "Biohazard" symbol and autoclaved properly before discarding in the trash.
- All personnel should wash their hands following the completion of laboratory activities, after removal of gloves and protective clothing, and before leaving the laboratory or contaminated work area. If hand-washing facilities are not available antiseptic hand cleansers are to be used. Hands are to be washed as soon as feasible.
- In the event of an exposure to eyes, mouth, mucus membrane, non-intact skin or parenteral contact, the area contacted should be washed with soap and water immediately. A medical evaluation should be performed immediately and the Safety Officer notified. Please reference Post-Exposure Evaluation and Follow Up section below for full instructions.
- Contaminated materials (non-regulated medical waste): paper towels, sponges, etc; should be double bagged and tagged for disposal in the county landfill.
- Contaminated laundry shall be handled wearing gloves and placed in "Biohazard" marked, orange or red bags immediately after use. It should be handled minimally and not separated in the work area.
Exposure Control Plan - Category II
- Utility gloves have been provided and should be used in all situations where contact with body fluids is possible.
- Utility gloves, which have been used and have contacted body fluids should be placed in a double plastic bag and taken to the Infirmary for disposal or decontamination.
- There is always a possibility that trash bags/cans could contain a hypodermic syringe/needle. If these type items are encountered they should not be removed. Place the trash bag in a box and contact the Safety Officer.
- Flush waste drains if possible before servicing, use gloves, goggles and boots for major sewer line work. If sharps are encountered use a tool to remove the pieces.
- If body fluids are involved in a cleaning job decontaminate using 10 parts water and 1 part bleach or other EPA approved disinfectant. If broken glass is present do not pick it up with your hands use a broom and dust pan.
- Should accidental contact with body fluids or a needlestick occur, the area contacted should be washed with soap and water as soon as feasible. The employee must be evaluated at the Infirmary as soon as possible after the incident and a report should be filed with the University Safety Office at the Facilities Management for Worker's Compensation record keeping purposes.Please reference Post-Exposure Evaluation and Follow Up section below for full instructions.
- If fluids contact personal clothing or equipment, these items should be washed thoroughly in 10 parts water and 1 part bleach or other EPA approved disinfectant.
Hepatitis B Vaccination
The University will provide hepatitis B vaccinations for all employees in Category I and Category II job classifications and for all employees who have had an exposure incident. The vaccination is voluntary.
The vaccination may be obtained from Health Services and is charged to the employees department. All employees must review the Hepatitis B Information Sheet and either take the vaccination (and fill out the Hepatitis B Vaccination Consent Form) or decline the vaccination (and fill out the Hepatitis B Vaccination Declination Form).
Post-Exposure Evaluation and Follow up
All overt accidental exposures of personnel to biohazardous agents, such as exposure to a concentrated contaminated aerosol from research procedures, accidental spills, or accidental inoculation with a contaminated needle, should be reported immediately. The following steps should be taken:
- Vigorous washing of the affected areas and notification of Health Services.
- Documentation of the route(s) of exposure, and the circumstances under which the exposure incident occurred. Documentation of the exposure should be made by the supervisor utilizing the Supervisor Accident/Incident Investigation Report and returned to the Safety & Risk Management Office
- Identification and documentation of the source individual, unless the employer can
establish that identification is infeasible or prohibited by state or local law.
- The source individual's blood shall be tested as soon as feasible and after consent is obtained in order to determine HBV and HIV infectivity. If consent is not obtained, the employer shall establish that legally required consent cannot be obtained.
- When the source individual is already known to be infected with HBV or HIV, testing for either is not required.
- Results of the source individual's testing shall be made available to the exposed employee, and the employee shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual.
- Collection and testing of the exposed employee's blood for determining HIV and HBV
serologic status.
- The exposed employee's blood shall be collected as soon as feasible and tested after consent is obtained.
- If the employee consents to baseline blood collection, but does not give consent at that time for HIV serologic testing, the sample shall be preserved for at least 90 days. If, within 90 days of the exposure incident, the employee elects to have the baseline sample tested, such testing shall be done as soon as feasible.
- Post-exposure prophylaxis will be administered when medically indicated.
- Counseling on the immediate and long-term effects of potential infectious agents will be discussed with the exposed individual.
- The exposed employee will be encouraged to report all related diseases and problems to some one on the physician staff of the Health Services for follow-up.
- All information should be recorded on the Blood Borne Pathogen Post Exposure Flow Sheet.
Training: Each employee in Category I and II are required to attend initial and annual training in bloodborne pathogens. The Safety & Risk Management Office and the University Health Service provides this training.