1. 2011 UF Bloodborne Pathogen Training
Biological Safety Office
Environmental Health & Safety
Sharon Judge, PhD
Assistant Biosafety Officer

2. Bloodborne Pathogens (BBPs)
Pathogenic microorganisms present in blood and other potentially infectious material (OPIM) that are able to cause disease in humans
Hepatitis B virus (HBV, HepB)
Hepatitis C virus (HCV, HepC)
Human immunodeficiency virus (HIV)
Less commonly, human T-lymphotropic virus (HTLV-1), Epstein-Barr virus (EBV), malaria, brucellosis, rabies, leptospirosis, babesiosis, syphilis, Creutzfeld-Jakob disease, arboviral infections (WNV, EEE), etc.

3. BBP Standard
Implemented in 1991 by the Occupational Safety & Health Administration (OSHA)
29 CFR
Revised in 2001 – safe sharps devices, maintain a log of injuries from contaminated sharps
UF follows OSHA requirement
General and workplace-specific training
Completed BEFORE individual is assigned to tasks with the potential for BBP exposure and ANNUALLY thereafter

4. BBP Standard
In addition to training, individuals with potential exposure must also have:
Access to the regulatory text and an explanation of its contents
Access to a copy of the UF Exposure Control Plan
Access to site-specific Standard Operating Procedures (SOPs)

5. UF BBP Program Chairs/Directors Faculty/Supervisors
Ensure dept. compliance
Faculty/Supervisors
Ensure appropriate exposure control plan is in place and being followed
Employees, students, volunteers, etc
Follow exposure control plan, report problems/exposure
SHCC/Occ. Med
Immunizations & post-exposure follow-up
EH&S Biosafety
Develop/coordinate program, track participants

6. UF BBP Program
ALL employees, staff, students, volunteers, affiliates with potential exposure to BBP from human blood/OPIM
Custodians, medical providers, dentists/dental staff, autopsy staff, clinical laboratory staff, research lab staff & students, biomedical engineers, athletic trainers, event staff, police, emergency responders, physical plant workers…etc

7. *unless visibly contaminated
What constitutes OPIM?
YES
NO*
Cerebrospinal fluid
Tears
Synovial fluid
Feces
Peritoneal fluid
Urine
Pericardial fluid
Saliva
Pleural fluid
Nasal secretions
Semen/Vaginal secretions
Sputum
Breast milk
Sweat
Amniotic fluid
Vomit
*unless visibly contaminated
with blood

8. Common transmission modes
Cuts or punctures with contaminated sharp objects
Splashes to mucous membranes
Contamination of broken/non-intact skin

9. From the bizarre but true files…
A woman in KY was arrested and charged with public intoxication (March 2010)
While changing into an inmate uniform, she squirted a stream of breast milk into the face of a female deputy
The press release sparked a debate when it was noted that the deputy was able to “clean the biohazard off of her”
Does this constitute an occupational exposure?
Yes, breast milk is considered OPIM

10. UF Exposures ( )

11. 2010 Reported Sharps Exposures by Department

12. 2010 Reported Sharps Exposures UFHSC-Jax

13. Cornerstone of exposure prevention “UNIVERSAL PRECAUTIONS”
All human blood or OPIM is treated as infectious
Use:
Safety Equipment
Safe Work Practices
Personal Protective Equipment (PPE)
Standard precautions = universal precautions + body substance isolation. Applies to blood & all other body fluids, secretions, excretions (except sweat), nonintact skin, and mucous membranes

14. Use universal precautions to handle…
Human blood and OPIM
Objects/items contaminated by blood or OPIM
Unfixed human tissues/organs (other than intact skin)
Cell or tissue cultures that may contain BBP agents
Blood/tissues from animals infected with BBP agents

15. Research using human cell lines…
Use Universal Precautions for all human cell lines
ATCC started testing newly manufactured/deposited cell lines for common viral pathogens (HIV, HepB, HepC, HPV, EBV, and CMV) in January 2010
Many infectious agents yet to be discovered and for which there is no test
Remember HIV?
What about XMRV?

16. Hepatitis B (HepB, HBV)
Spread through direct contact with infected body fluids (blood, semen, vaginal fluids)
Infection may be acute or chronic
~ % of Americans have been infected with HepB
5-10 % of adults will develop chronic infection; ~1.2 million people with chronic HBV
15-25% develop cirrhosis , liver failure, or liver cancer (~ deaths/year)
Many people (~50%) are asymptomatic; if symptoms occur they include:
Fever
Abdominal pain
Fatigue
Loss of appetite
Nausea
Vomiting
Jaundice
Joint pain
Dark urine

17. Occupational HepB Exposures
Percutaneous
~30% of these exposures results in infection
Mucosal exposure to blood/body fluids
Exposure to nonintact skin from contaminated surfaces and equipment – HBV can remain infective in dried blood at RT for at least 1 week (MacCannell et al., Clin Liver Dis 2010; 14:23-36)

18. Preventing Occupational HepB Exposures
Get vaccinated!
Universal Precautions
Cleaning/disinfection

19. HepB Vaccine Safe Effective In Gainesville, free @UF SHCC (392-0627)
Given to newborns, 120 million people in U.S. have received at least one dose
Effective
>95% develop immunity after full series (3 doses given at 0, 1, 6 mos)
In Gainesville, SHCC ( )
Bring completed Acceptance/Declination statement with you
If you decline, can change mind at any time

20. Postvaccination testing
Health-care workers or public safety workers at high risk for continued percutaneous or mucosal exposure to blood or body fluids, HBV research lab workers
Performed 1-2 months after dose #3
HepB surface antibody (anti-HBs) ≥ 10 mIU/mL - immune
Anti-HBs < 10 mIU/mL – revaccinate (3 doses) and retest anti-HBs
Still negative – nonresponder, need HBIG after exposure
Previously vaccinated but not tested? Test for anti-HBs after an exposure; if negative, treat as susceptible.

21. Hepatitis C (HepC, HCV)
Transmitted primarily through contact with infected blood
Many people asymptomatic (symptoms similar to HepB)
~1.8 % of Americans have been infected with HepC, 3.2 million chronically infected
~ 12,000 deaths/year
Leading indication for liver transplant in U.S.

22. Occupational HepC Exposures
Percutaneous injury, esp. with deep punctures or extensive blood exposures
~2% develop infection
Mucosal/nonintact skin exposures rarely documented
Proper cleaning/disinfection of surfaces important
HCV in dried blood samples remains infective for at least 16 hours (Kamili et al., Infect Control Hosp Epidemiol 2007; 28: )
Universal Precautions for Prevention!
NO VACCINE
Antivirals (interferon/ribavirin) can have serious side effects, treatment lasts weeks

23. HIV Transmitted through contact with infected blood/OPIM 1° infection
transient, non-specific illness (fever, malaise, muscle pain, sore throat)
Asymptomatic phase
Symptomatic phase
↑ susceptibility to opportunistic infections, nonspecific constitutional symptoms (night sweats, weight loss, anorexia, fever)
Advanced (AIDS)
one or more opportunistic infections, CD4<200 cells/µl

24. HIV/AIDS - U.S. and Florida
> 1 million living with HIV/AIDS
~56,000 new infections/year
~20% don’t know they are infected
Florida ranks 3rd among states in the number of reported HIV/AIDS cases

25. Occupational HIV Exposures
Risk for HIV transmission after:
Percutaneous injury – 0.3%
Mucous membrane exposure – 0.09%
Nonintact skin exposure – low risk (< 0.09%)
57 documented occupational
infections in U.S. (139 possible infections)
84% resulted from percutaneous exposure!

26. If HIV is such low risk, why worry?
No cure
No vaccine
Antiretroviral therapy – cocktail of 3 or more drugs, costly, side effects, drug resistance
Always use Universal Precautions!

27. Comparing the risks…
Risks of becoming infected after a needle stick injury:
30% 2%
0.3%
*If unvaccinated*

28. Controls to Protect Against BBP Exposures

29. Primary Controls Engineering (safety equipment) Work Practices
Safety needles, sharps box, biosafety cabinet
Work Practices
Cleaning work surfaces, not recapping needles
Personal Protective Equipment (PPE)
Gloves, lab coat, face shield
Maximum protection when
these controls overlap

30. Engineering Controls Sharps container Biosafety cabinet
Cleanable work surfaces/chairs
Leak-proof transport containers
Safety needles/syringes

31. List of safety sharps devices available can be found at:

32. Work Practices Know what they are and follow them! Minimize splashes
Don’t recap needles
Know how to handle spills
Wash your hands!
No eating/drinking in areas where blood/OPIM is handled or stored

33. DO NOT RECAP NEEDLES Don’t bend, break, or detach from syringe
Discard needles directly into sharps container
Do not overfill the sharps box – close and replace when ¾ full
Never attempt to re-open a closed sharps box

34. Circumstances Associated with Hollow-Bore Needle Injuries
NaSH June 1995—December 2003 (n=10,239)
35% disposal
related

35. Decontamination/Disinfection
FRESHLY DILUTED (w/in 24 hrs) 1:10 solution of household bleach
EPA listed tuberculocidal disinfectant
Clorox, amphyl, lysol, sporicidin
Ethanol evaporates too quickly to be an effective disinfectant!

36. Do you know how to clean this?
Notify people in the area
Don appropriate PPE (gloves, safety glasses)
Place absorbent material on spill
Apply appropriate disinfectant – allow sufficient contact time (30 min)
Pick up material (watch for glass – use tongs or dust pan); dispose of as biowaste
Reapply disinfectant and wipe
For large/problematic spills, call EH&S Biosafety Office ( )

37. Do you have a bio-spill kit?
Container of undiluted household bleach
Several pairs of gloves
Safety glasses
Absorbent material
Biohazardous waste (autoclave) bags
Dust pan & scoop or tongs for broken glass
Place in a labeled bag or bucket and keep in areas where biohazards are used

38. Hand washing Pay attention to frequently missed
areas – fingertips, between fingers,
under jewelry
Wash hands after removing gloves & before leaving the work area
If no sink nearby, use hand sanitizer and then wash with soap and water ASAP

39. Personal Protective Equipment (PPE)
Wear it WHEN and WHERE you are supposed to
PPE should never be worn in common areas (offices, hallways, bathrooms, cafeterias, etc) or when handling common-use items (doorknobs, elevator buttons, telephones)
It is also common courtesy – others don’t know what you may have touched/where you have been

41. Absolutely no open toed
PPE
PPE must be supplied by the employer
It must fit, be suitable to the task (use common sense), and cleaned or disposed of properly (this does not mean taking it home to wash!)
Gloves
Face and Eye Protection
Surgical mask, goggles, glasses w/side shield, face shield
Body
Gowns, aprons, lab coats, shoe covers
Absolutely no open toed
shoes in the lab!

42. Gloves Never re-use or wash gloves!
Some chemicals may breakdown the glove – use glove compatibility chart

43. Pay attention to how you remove your gloves!
WASH HANDS!
Pay attention to how you remove your gloves!

44. Exposure Control Plan and Standard Operating Procedures (SOPs)
Site-specific!
Equipment, practices, and PPE used AT YOUR SITE to protect you and others
Written down, reviewed, accessible, updated annually or as needed
Template for SOPs:

45. HIV/Hepatitis Research Labs
More stringent control measures
Work must be registered with EH&S Biosafety Office (rDNA or BA registration)
Enrollment in medical surveillance program
Follow CDC/NIH BSL-2 containment practices at a minimum

46. If you have an exposure:
Wash wound with soap & water for 5 minutes; flush mucous membranes for 15 minutes
Seek immediate medical attention (1-2 hrs max)
In Gainesville, call (Needle Stick Hotline)
In Jacksonville, 7am-4pm, go to Employee Health Suite 505 in Tower 1; Other hours, go to ER
Other areas, go to the nearest medical facility
Notify supervisor
Contact UF Worker’s Compensation Office,
Allow medical to follow-up with appropriate testing & required written opinion

47. Call this number 24 hours a day, 7 days a week for all needle sticks and biological exposures!

48. Factors considered in assessing need for PEP
Type of exposure
Type/amount of fluid/tissue
Infectious status of source
Susceptibility of exposed person
Percutaneous injury (depth, extent, device)
Blood
Presence of HepB surface antigen (HBsAg) and HepB e antigen (HBeAg)
HepB vaccine and vaccine response status
Mucous membrane exposure
Fluids containing blood
Presence of HepC antibody
Immune status
Non-intact skin exposure
Presence of HIV antibody
Bites resulting in blood exposure to either person
CDC PEP Guidelines:

49. Record Keeping Requirements
Training records:
Retain a minimum of 3 years
Medical records for immunization or post-exposure follow up:
Retain for duration of employment + 30 yrs (includes HepB vaccination records, vaccination declination statement)
Confidential sharps injury log (type of device involved, where and how injury occurred):
Retain for 5 years from date of exposure

50. Warning labels must be placed on:
BBP standard requires that a labeling system be in place to warn people about the potential for BBPs
Warning labels must be placed on:
Containers of regulated waste
Refrigerators & freezers containing blood or OPIM
Containers used to store, transport, or ship blood or OPIM
Use red bags for waste containers

51. Questions?

52. 2011 UF Biomedical Waste Training
Biological Safety Office
Environmental Health & Safety

53. Biomedical Waste Training
State regulations require that all employees who may have contact with BMW receive:
initial training at time of hire
annual refresher training
Training shall cover:
Identification, handling, use of protective clothing, segregation, storage, labeling, transport, procedures for decontaminating BMW spills, contingency plan for emergency transport, and procedure for containment and treatment of BMW.
Training must be facility and site specific
Training Log/roster must be kept for a minimum of 3 years
Documentation of individual employee training is to be kept in their department.

54. What is Biomedical Waste (BMW)?
Any solid or liquid waste which may present a threat of infection to humans
Includes but is not limited to:
Non-liquid human tissue and body parts
Blood, blood products and OPIM (as defined in OSHA BBP standard) from humans and other primates
Laboratory/clinical waste containing/contaminated with blood, tissue, cell cultures & other potentially infectious body fluids
Laboratory/veterinary wastes containing human disease-causing agents
Discarded sharps (medical items intended to cut or puncture skin, e.g. needles, syringe/needle combinations, lancets, scalpels)

55. Biomedical vs. Biological vs. Hazardous Waste
Biomedical waste – specifically regulated by the State of Florida Dept. of Health
BMW is infectious for humans & a subset of biological waste
Various regulations affect biological waste (NIH, USDA, etc)
Biological waste includes rDNA, animal, & plant pathogens
Hazardous waste is a non-specific term. At UF, most often used to describe chemical waste or chemically- contaminated waste (pharmaceutical waste also handled as chemical waste).

56. Examples of BMW?
Used, absorbent materials saturated with blood, body fluids, or secretions/excretions contaminated with blood & absorbent materials saturated with blood or blood products that have dried (bandages, gauze, sponges, wound care material).
Non-absorbent disposable devices (flexible tubing, disposable gloves, intact glass and hard plastic, etc) contaminated with blood, body fluids, or secretions/excretions contaminated with blood but have not been sterilized or disinfected by an approved method.
Other contaminated solid waste which represents a significant risk of infection b/c they are generated in medical facilities which care for persons suffering from diseases requiring isolation criteria.

57. State Requirements
Described in Chapter 64E-16 FL Administrative Code
Segregation, handling, labeling, storage, transport & treatment are regulated. Prescribe specific:
Sanitary practices
Training
Biomedical waste plan – provides guidance & describes requirements for proper management of biomedical waste at the generating site or facility
Permits req’d to generate, store, treat, & transport BMW
Inspections by the state
Enforcement

58. Biomedical Waste Plan
Content of this presentation closely follows the UF Biomedical Waste Plan which is located in EH&S Biosafety Office. Contact
The BMW plan for Shands UF is located in the Environmental Services Dept., Room G137 (South Tower) and Room B301.8 (North Tower). Contact
Other departments at UF/Shands may create and maintain a BMW plan for their area using the following template:

59. How is BMW identified?
International biological hazard symbol on the container
The phrase “Biomedical Waste”, “Infectious Waste” or “Biohazardous” must be on the container
Bagged waste must be in red bags.

60. Segregation of BMW at UF/Shands
Segregated at point of origin into its proper container
“Point of origin” is the lab, patient/exam/procedure room or other area where the BMW is generated
Choices for proper BMW container:
Red biowaste bag
Labeled fiberboard box lined with a biowaste bag
Sharps container – puncture resistant container specifically designed for sharps

61. Segregation: Do not mix BMW with radioactive or chemical waste!
Chemically or radiologically contaminated gloves, tubes, etc. do not go into a biomedical waste box. They go into their appropriate waste container.
Call EH&S ( ) before putting hazardous (chemical) or radioactive warning stickers on biomedical waste containers.
Remember – the biomedical waste box is not a universal disposal container!

62. Segregate medical sharps into sharps containers
Never Re-Cap Needles or Scalpels
Don’t bend, break, or detach from syringe
Discard directly into a leak-proof, puncture resistant container
Replace container when ¾ full
Label container with facility’s name and address prior to offsite transport
UF labs - date, PI name, room and phone #

63. Sharps
Container should be located where the sharps are used: patient rooms, procedure areas, exam rooms, lab, etc.
UF uses disposable containers transported for disposal by Stericycle
Shands uses reusable containers which are supplied & serviced by Bio Systems
Only sharps should go into sharps containers
Soft items quickly overfill containers and may cause sharps to stick out of the top of the box. Sharps boxes containing items other than sharps and syringes need to be replaced ASAP, but definitely within the 30 days of first use

64. What do we do with non-sharp BMW?
RED autoclave bags – must meet certain documented standards of State of FL, BBP & DOT
e.g. Fisher #01-828E (Medical Action Industries)
Red bags are to be available where needed
No liquid waste in red bags!
Once sealed, containers must stay sealed. If container breaks or is punctured, put the whole broken container in a new one.
Infectious/potentially infectious waste must be stored in a covered, leak-proof container

66. BMW Storage
BMW must be staged in an area away from general traffic & accessible only to authorized personnel. Storage area must be:
Labeled with biohazard sticker
Secure (locked/non-accessible)
Easily cleanable & tidy
Waste cannot be stored > 30 days
“The 30 day period shall commence when the first non-sharps item of biomedical waste is placed into a red bag or sharps container, or when a sharps container containing only sharps is sealed.”
Packages must be labeled as biomedical waste with the biohazard symbol, lab name, location, phone & date
Some locations stage the waste & then transport it to outdoor containers removed for disposal by a designated hauler

67. BMW Staging Locations at Shands
Staging locations provided on each floor/as needed
In some areas, BMW is picked up from the “point of use” location
North & South Tower staging: the Soiled Holding Room on each nursing unit
South Tower: Rm 1172 ED Soiled Hold, Rm 1185 ED Soiled Hold, Rm 1236 Radiology Soiled Hold, Rm 8219 Soiled Hold, Rm Soiled Hold, Rm 2136 OR Soiled Hold, G316 Biowaste Staging, etc.
North Tower: Soiled holding areas on patient care and treatment areas, CSS and OR soiled holding area such as 3236, 2426, 3522, 6445, 9515 or , etc

68. Handling BMW
Wear appropriate PPE (gloves, clothing cover, safety glasses) when handling non-inactivated waste
Use Universal Precautions – assume all BMW is infectious
Transport waste in leak-proof containers
Know how to handle spills

69. Supplies for Handling and Containing BMW
At UF:
Labs must furnish their own PPE and red bags (Fisher #01-828E)
Sharps containers and BMW boxes are available from Building Services custodians or from AG133 at the Health Science Center (call ) or from Physical Plant Stores, Bldg 705 near the Motor Pool (call )
At Shands, staff may obtain any of the supplies by:
Contacting Environmental Services at or
Speaking to an Environmental Services staff associate on the unit they are working

70. Who Picks Up/Transports BMW for Shands/UF?
Transportation of BMW is provided by the following registered BMW transporter:
Stericycle, Inc.
4245 Maine Ave
Eaton Park, FL 33840
State of Florida Permit #

71. Contingency Plan
Stericycle has a number of other sites in the state that they can pull transport equipment from to facilitate emergency situations

72. Treatment of BMW
BMW shall be treated by heat, incineration, or other equivalent method suitable for hazard inactivation acceptable to the State of Florida.
Shands/UF BMW is treated by Stericycle, Inc.
Autoclave which sterilizes the waste or
Incineration which destroys the waste
Note: CJD BMW must be marked for incineration per hospital policy by the area that has filled the container. See ICP 03-15, Guideline for the Management of Patients with Suspected or Confirmed Creutzfeldt-Jakob Disease (CJD) or other prion disease

73. Pretreatment of biological waste from UF labs prior to disposal by Stericycle
At UF, all lab waste handled by UF custodial staff
UF Policy:
Laboratory waste containing infectious, potentially infectious, or rDNA organisms must be inactivated prior to disposal
Properly performed autoclave or bleach treatment is acceptable
Storage of all non-inactivated waste in this category is restricted to within the generating laboratory
Specific requirements apply for waste containing biological toxins. Contact the Biological Safety Office at

74. Autoclaving Requirements:
Biological indicator testing every 40 hrs of use (every 6 mos if autoclaving non-infectious material exclusively)
Log book
Regular maintenance
250°F/121°C, lb pressure
Large loads/resistant pathogens need more time
Typical bag of Biohazardous Waste = 60 min
Transport BMW to autoclave in closed bag and leak-proof container

75. Bleach Inactivation of BMW
Acceptable for liquid material if done correctly
Add full strength household bleach to final concentration of 10% (5000 ppm available chlorine).
Mix. Contact time should be at least 30 minutes.
Pour down drain to sanitary sewer.
Beware of other disinfectants = “hazardous chemicals”, harmful work with and can’t go down drain, must be picked up by EH&S

76. BMW Spills & Surface Disinfection
Proper spill handling:
Notify people in the area
Don appropriate PPE
Place absorbent material on spill
Apply appropriate disinfectant – allow sufficient contact time (30 min)
Pick up material (watch for glass – use tongs or dust pan); dispose of material into biomedical waste
Reapply disinfectant and wipe
For large/high hazard spills, call the Biosafety Office ( )
For routine disinfection of surfaces where BMW is handled, use a 1:10 solution of freshly diluted bleach or a tuberculocidal disinfectant (ethanol evaporates too quickly!)
Shands uses VIREX, a hospital level disinfectant/germicidal cleaner (Didecyl dimethyl ammonium chloride) to clean and disinfect surfaces.

77. Questions? Contact: The UF Biological Safety Office 352-392-1591