To establish minimum sanitary practices relating to the proper segregation, handling, labeling, storage, treatment, and disposal of biological waste, as required by Chapter 64E-16, Florida Administrative Code, Florida Statutes Chapter 381.006, and the Code of Federal Regulations Ch. 29, part 1910.1030, so as to minimize exposure of employees, patients, the public, and the environment to disease-causing agents.

Application:

This procedure applies to all biomedical waste generators at Florida Gulf Coast University.

Definitions: 

Biohazard - Any potentially hazardous or regulated biological material applicable to any laws, contracts, permits, and accepted biosafety guidelines. 

Biological/Biomedical/Biohazardous Waste - Any solid or liquid waste presenting a threat of infection to humans. This may include non-liquid tissue, body parts, blood, blood products, or body fluids containing human disease-causing agents; discarded sharps; pathological and microbiological waste containing blood or other potentially infectious materials; any materials contaminated with any potentially infectious materials. Any animal carcasses or parts.

Biomedical Waste Generator - A facility or person producing a biomedical or biohazardous waste.

Contaminated - Soiled by any biomedical waste.

Decontaminated - The process of removing pathogenic microorganisms from objects or surfaces, rendering them safe for handling.

EH&S - Environmental Health and Safety (at Florida Gulf Coast University)

F.A.C. - Florida Administrative Code

F.S. - Florida Statute

Hazardous Waste - Those materials defined in Chapter 62-730, F.A.C.  

Point of Origin - The room or area where a biological waste is generated.

Puncture Resistant - Able to withstand punctures from contained sharps during normal usage and handling.

Restricted - The use of a lock, sign, or location, to prevent unauthorized entry.

Sharps - Objects capable of puncturing, lacerating, or otherwise penetrating the skin or waste bag.

Site-specific biomedical waste plan - The plan developed by each generator outlining the specific procedures for segregation, handling, labeling, storing, and disposing of biomedical waste generated at that site. 

Transfer - Moving biomedical waste within a facility. 

Transport - Moving biomedical waste away from a facility.

Treatment - Any process, including steam, chemical exposure, microwave shredding, or incineration, which changes the character or composition of biomedical waste to render it noninfectious.

Responsibilities of the Biomedical Waste Generator:

1. Implement specific biomedical waste procedures in accordance with the requirements set forth in this document.
2. Identify and segregate biomedical waste from other waste streams at the point of origin. Segregate contaminated sharps from non-sharps biological waste.
3. Treat all biological waste known to contain NIH Risk Group 3 or 4 agents through autoclaving or other treatment method before it leaves the point of origin.
4. Manage biological waste mixed with hazardous waste, as defined by Chapter 62-730, F.A.C. , as a hazardous waste.
5. Dispose of all radioactive waste according to the FGCU Radiation Safety Manual and Chapter 64E-5, F.A.C.
6. Properly package all biomedical waste prior to removal from the restricted area. Package and seal all biomedical waste, except loose sharps, in impermeable, red plastic bags inside the approved outer box. The bags, boxes, and bins supplied by EH&S and MWASTE meet the specifications of 64E-16.011 F.A.C.
7. Discard sharps at the point of origin into a sharps container. Seal sharps containers when ¾ full. The international biological hazard symbol, at least one inch in diameter, must be on all sharps containers. Note: “Broken Glassware”, not contaminated with biological material, goes into separate, specially marked containers disposed in regular trash dumpsters.
8. Place sealed biomedical waste bags and sealed sharps containers into the biomedical waste boxes provided by EH&S. Tape all of the box seams, and do not overfill.
9. Mark or label the outside of the box with the point of origin (room number), name, and date. Place the box in the proper location for pick-up by EH&S or MWASTE personnel.
   Note: Transporters will not pick up improperly packaged, unlabeled, or leaking waste containers.
10. Place solid materials from a spill cleanup into an appropriate package and dispose as biomedical waste. Clean any surface contaminated with biomedical waste with a solution of detergent to remove visible soil and then disinfect with a bleach solution, alcohol, or other appropriate germicidal solution.  Dispose of liquid waste from a chemical disinfection operation via the sanitary sewer system.
11. Train all employees who may handle biomedical waste according to the specific biomedical waste procedure. Train employees before they come into contact with biomedical waste, and annually thereafter. Maintain a record of the training for at least 3 years.

Storage and Containment:

1. Biomedical waste storage may not exceed 30 days. The 30-day period begins when the first non-sharps item of biomedical waste is generated, or when a sharps container storing only sharps is sealed.
2. Indoor storage areas shall have restricted access and be designated in the specific biomedical waste procedure. They shall be located away from pedestrian traffic (storage cannot be in hallways, restrooms, classrooms, or other readily available public areas). Storage areas shall be vermin and insect free, and maintained in a sanitary condition.
3. Outdoor storage areas and containers must be conspicuously marked with the international biological hazard symbol, a minimum of 6 inches in diameter, and be secured against vandalism and unauthorized entry.  
4. The biomedical waste shed near Academic Building 7 (AB7) in Parking lot 1 is the main on-site storage location for biomedical waste. Additional locations include Whitaker Hall, Alico Arena and Howard Hall. Other temporary storage locations may be designated with approval from EH&S.

Labeling:

1. Bags, outer containers, and generator barcode labels are provided by the transporter. Cardboard containers are pre-printed with the transporter's name, address, registration number, and 24-hour telephone number. Reusable containers are labeled accordingly prior to transport. All outer waste containers must be rigid, leak resistant and puncture resistant. Reusable outer containers shall be constructed of smooth, easily cleanable materials and shall be decontaminated after each use.
2. All packages containing biomedical waste shall be visibly identifiable with the international biological hazard symbol and one of the following phrases: “BIOMEDICAL WASTE", "BIOHAZARDOUS WASTE", "BIOHAZARD","INFECTIOUS WASTE", or "INFECTIOUS SUBSTANCE", according to 29 C.F.R. 1910.1030, Occupational Exposure to Blood borne Pathogen Standard.

Transport Requirements:

Only a State approved transporter (currently MWaste Medical Waste Technologies of Naples) may remove the biomedical waste containers from campus.

Permits and Exemptions: 

Contact EH&S for information regarding the required permits and exemptions for the University.

Recordkeeping:

1. Environmental Health & Safety will maintain the required records documenting transportation and disposal of biomedical waste (manifests, certificates of destruction, and invoices).
2. Biomedical waste generators must maintain their specific written procedures and training records. All biomedical waste records must be maintained for a minimum of 3 years.

References and Resources:

Chapter 64E-16, Florida Administrative Code

Code of Federal Regulations Ch. 29, section 1910.1030

Biosafety in Microbiological and Biological Laboratories  (BMBL) 5th Edition, Centers for Disease Control, Office of Health & Safety (OHS)

Biosafety in the Laboratory: Prudent Practices for Handling and Disposal of Infectious Materials, National Academy Press, Washington, D.C. (1989).

 New Training Opportunity!

Biosafety Training and Certificates are now available on the CITI website. The CITI Program is a subscription service providing research ethics education to all members of the research community. To participate fully, learners must be affiliated with a CITI participating organization. Access to the CITI training is provided by the FGCU Office of Research and Sponsored Programs. For additional information regarding registering for this training, please contact Sandra Tarranova at sterranova@fgcu.edu .

 Rev. 4/2013 R. Holtzclaw