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Biological Safety Office
Environmental Health & Safety
352-392-1591
www.ehs.ufl.edu
[email protected]
Sharon Judge, PhD
Assistant Biosafety Officer

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.

Implemented in 1991 by the Occupational Safety &
Health Administration (OSHA)

29 CFR 1910.1030
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051

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

In addition to training, individuals with potential exposure
must also have:

Access to the regulatory text and an explanation of its contents
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051

Access to a copy of the UF Exposure Control Plan
http://www.ehs.ufl.edu/Bio/BBP/ECP2011.pdf

Access to site-specific Standard Operating Procedures (SOPs)
http://www.ehs.ufl.edu/Bio/BBP/BBPSOPS.pdf

Chairs/Directors
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

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
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
1. Cuts or punctures with contaminated sharp objects
2. Splashes to mucous membranes
3. Contamination of broken/non-intact skin

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

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

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

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?


Spread through direct contact with infected
fluids (blood, semen, vaginal fluids)
Infection may be acute or chronic




body
~4.3-5.6% 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 (~ 3000
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

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)

Get vaccinated!

Universal Precautions

Cleaning/disinfection

Safe


Effective


Given to newborns, 120 million people
in U.S. have received at least one dose
>95% develop immunity after full series
(3 doses given at 0, 1, 6 mos)
In Gainesville, free @UF SHCC
(392-0627)


Bring completed
Acceptance/Declination statement with
you
http://www.ehs.ufl.edu/Bio/BBP/TNV.pdf
If you decline, can change mind at any
time

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.

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.

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; 28:519-524)

Universal Precautions for Prevention!


NO VACCINE
Antivirals (interferon/ribavirin) can have serious side effects,
treatment lasts 24-48 weeks


Transmitted through contact
with infected blood/OPIM
1° infection



Asymptomatic phase
Symptomatic phase


transient, non-specific illness
(fever, malaise, muscle pain,
sore throat)
↑ susceptibility to opportunistic
infections, nonspecific
constitutional symptoms (night
sweats, weight loss, anorexia,
fever)
Advanced (AIDS)

one or more opportunistic
infections, CD4<200 cells/µl
 > 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

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!

No cure

No vaccine

Antiretroviral therapy – cocktail of 3 or more drugs,
costly, side effects, drug resistance

Always use Universal Precautions!

Risks of becoming infected after a needle stick injury:
35%
30%
30%
25%
20%
15%
10%
5%
2%
0.3%
0%
HepB
*If unvaccinated*
HepC
HIV

Engineering (safety equipment)
◦ 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
Sharps container
 Biosafety cabinet
 Cleanable work surfaces/chairs
 Leak-proof transport containers
 Safety needles/syringes

List of safety sharps devices available can be found at:
http://www.healthsystem.virginia.edu/internet/epinet/safetydevice.cfm#1

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
NO!!
NO!!

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
Circumstances Associated with Hollow-Bore Needle Injuries
NaSH June 1995—December 2003 (n=10,239)
35% disposal
related

FRESHLY DILUTED (w/in 24 hrs) 1:10 solution of
household bleach

EPA listed tuberculocidal disinfectant
◦ http://www.epa.gov/oppad001/chemregindex.htm
◦ Clorox, amphyl, lysol, sporicidin

Ethanol evaporates too quickly to be an effective
disinfectant!
Notify people in the area
2.
Don appropriate PPE (gloves, safety glasses)
3.
Place absorbent material on spill
4.
Apply appropriate disinfectant – allow sufficient contact time (30 min)
5.
Pick up material (watch for glass – use tongs or dust pan); dispose of
as biowaste
6.
Reapply disinfectant and wipe
For large/problematic spills, call EH&S Biosafety Office (392-1591)
1.






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
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

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


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!
Gloves
 Never re-use or wash gloves!
 Some chemicals may breakdown the glove –
use glove compatibility chart
http://www.ehs.ufl.edu/Lab/CHP/gloves.htm
Pay attention to how you remove your gloves!
WASH HANDS!

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:
http://www.ehs.ufl.edu/Bio/BBP/BBPSOPS.pdf

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


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 1-866-477-6824 (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, 352-392-4940
Allow medical to follow-up with appropriate testing & required
written opinion
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
Type of exposure
Non-intact skin
exposure
Presence of HIV
antibody
Bites resulting in
blood exposure to
either person
CDC PEP Guidelines:
http://www.cdc.gov/mmwr/PDF/rr/rr5409.pdf
http://www.cdc.gov/mmwr/PDF/rr/rr5011.pdf

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

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
Biological Safety Office
Environmental Health & Safety
352-392-1591
www.ehs.ufl.edu
[email protected]

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:

Training must be facility and site specific
◦ 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 Log/roster must be kept for a minimum of 3 years
◦ Documentation of individual employee training is to be kept in their
department.

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)

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 chemicallycontaminated waste (pharmaceutical waste also handled
as chemical waste).

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.

Described in Chapter 64E-16 FL Administrative Code
http://www.doh.state.fl.us/environment/community/biomedical/pdfs/64E16_1.pdf

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

Content of this presentation closely follows the UF
Biomedical Waste Plan which is located in EH&S Biosafety
Office. Contact 352-392-1591.

The BMW plan for Shands UF is located in the
Environmental Services Dept., Room G137 (South Tower)
and Room B301.8 (North Tower). Contact 352-265-0480.

Other departments at UF/Shands may create and maintain
a BMW plan for their area using the following template:
http://www.doh.state.fl.us/environment/community/biomedical/index.html

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.

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

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 (352-392-1591) before putting hazardous
(chemical) or radioactive warning stickers on biomedical
waste containers.

Remember – the biomedical waste box is not a universal
disposal container!

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 #

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

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

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

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
7121 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 11-532, etc

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

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 392-5775) or from Physical Plant Stores, Bldg 705 near the
Motor Pool (call 392-1115)

At Shands, staff may obtain any of the supplies by:
◦ Contacting Environmental Services at 352-265-0480 or
◦ Speaking to an Environmental Services staff associate on the unit
they are working

Transportation of BMW is provided by the following
registered BMW transporter:
Stericycle, Inc.
4245 Maine Ave
Eaton Park, FL 33840
407-361-5454
State of Florida Permit # 53-64-00911

Stericycle has a number of other sites in the state that
they can pull transport equipment from to facilitate
emergency situations

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

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 352-3921591

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, 15-20 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

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

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 (352-392-1591)

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.
Contact: The UF Biological Safety Office
352-392-1591
[email protected]
www.ehs.ufl.edu