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Denise Passerieux, AuD., CCC‐AJUNE 4, 2018
New York State Infection Control
for Hearing Healthcare
CODE OF ETHICS OF AUDIOLOGYCODE OF ETHICS OF AUDIOLOGY
“Individuals shall exercise all reasonable precautions to avoid injury to person in the delivery of professional services or execution
of research.”American Academy of Audiology Part 1, Principle 2, Rule 2b
Who and what do audiologists come in contact with daily?
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Audiologists serve a diverse population of patients
Also, come into contact with the individual patients and their significant others that accompany the patient to their appointment
Audiologists serve a diverse population of patients
Also, come into contact with the individual patients and their significant others that accompany the patient to their appointment
The medical history of the patient is often not known until walks into office
Also unknown….the medical history of the accompanying friend/significant other
WHAT IS INFECTION CONTROL?WHAT IS INFECTION CONTROL?
Infection control is a process that involves the conscious management of the clinical environment for the specific purposes of minimizing the
potential spread of disease.
(Bankaitis and Kemp, 2003‐2005)
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PRI
Probe tip use
Dispensing and handling of hearing aids
Cerumen management
Touching common surfaces
Not washing hands
Sneezing/coughing
There is always a risk of exposure to pathogens
…..as well risk for cross contamination
GOAL OF INFECTION CONTROLGOAL OF INFECTION CONTROL
Reduce or eliminate opportunities
for direct or indirect transmission of
microorganisms from person to
person
(Kemp & Bankaitis 2000a, Kemp & Bankaitis 2000b)
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TRANSMISSION OF DISEASETRANSMISSION OF DISEASE
MODES OF DISEASE TRANSMISSIONMODES OF DISEASE TRANSMISSION
Contact
Vehicle
Airborne
Vector borne
MODES OF DISEASE TRANSMISSIONMODES OF DISEASE TRANSMISSION
Contact TransmissionMost common in clinical environment
Three different means of contract transmission:
Direct
Indirect
Droplet
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MODES OF DISEASE TRANSMISSION ‐CONTACTMODES OF DISEASE TRANSMISSION ‐CONTACT
Person comes in direct contact with a microbe
Draining ear
Contaminated cerumen
Vomit
Direct Contact
MODES OF DISEASE TRANSMISSION ‐CONTACTMODES OF DISEASE TRANSMISSION ‐CONTACT
Indirect Contact
Handle or re‐use a contaminated object
Using a stethoset on two
different hearing aids
without cleaning the “bell”
in between uses
Hand shake ‐
MODES OF DISEASE TRANSMISSION ‐CONTACTMODES OF DISEASE TRANSMISSION ‐CONTACT
Droplet Transmission
Transmits infectious microbes through water droplets with direct or indirect contact with linings of eye, nose or mouth
Picked up by person through coughing/sneezing, spitting, singing
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MODES OF DISEASE TRANSMISSION ‐MODES OF DISEASE TRANSMISSION ‐
Microbe travels through air as droplet/dust particles from one person to another
Enters through respiratory system
Airborne
MODES OF DISEASE TRANSMISSION‐
VEHICLEMODES OF DISEASE TRANSMISSION‐
VEHICLEMicrobe ‘catches a ride’ on food/water
Ingest or exposed to the contaminated microbe
Transmitted through:
Bodily substances
Contaminated water
Contaminated food
Contaminated blood
MODES OF DISEASE TRANSMISSION‐
VECTOR BORNE
MODES OF DISEASE TRANSMISSION‐
VECTOR BORNE
Microbes carried by an infected animal or insect
Mosquito
Tick
Rat
Insect
We are coming to get you!!
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INFECTIOUS DISEASES INFECTIOUS DISEASES
PATHOGENSPATHOGENS
Primary‐
Microorganisms that cause diseases in healthy individual.
Opportunistic (Secondary)‐
Microorganisms only cause disease when a person has immunocompromised system.
a microorganism that causes disease
PRIMARY PATHOGENSPRIMARY PATHOGENS
We must be concerned about primary and opportunistic infections in ALL audiology
settings
Protect yourself
Protect your patients
Utilize universal precautions
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WHO IS AT RISK FOR OPPORTUNISTIC INFECTION?
WHO IS AT RISK FOR OPPORTUNISTIC INFECTION?
Elderly
Diabetic (Type I and Type II)
HIV/AIDS
Hepatitis (Hepatitis B)*
SARS (Severe Acute Respiratory Syndrome)*
Tuberculosis*
PRIMARY INFECTIONS ANDOPPORTUNISTIC INFECTIONSPRIMARY INFECTIONS ANDOPPORTUNISTIC INFECTIONS
Concern regarding primary and opportunistic infections in ALL audiology settings
is real.
Protect yourself Protect your patients
UTILIZE UNIVERSAL PRECAUTIONS!
TYPES OF INFECTIOUS DISEASESTYPES OF INFECTIOUS DISEASES
Bacterial
Viral
Fungal
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BACTERIAL INFECTIOUS DISEASES
BACTERIAL INFECTIOUS DISEASES
Millions of bacteria are located throughout body.
Infection is caused by microscopic organisms that are pathogenic.
Harmful bacteria may also emit toxins that damage the body.
BACTERIAL INFECTIOUS DISEASESBACTERIAL INFECTIOUS DISEASES
Tuberculosis – Mycobacterium tuberculosis
Streptococcal bacteria
Neisseria meningitidis
H Pylori ‐ Helicobacter pylori
E‐Coli ‐ Escherichia coli
Salmonella
VIRAL INFECTIOUS DISEASES VIRAL INFECTIOUS DISEASES Virus is a living organism that cannot survive/replicate without host organism/cell (parasitic relationship)
There is no cure, but there are vaccinations to reduce chance of spreading.
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VIRAL INFECTIOUS DISEASESVIRAL INFECTIOUS DISEASES
SARS‐ Severe Acute Respiratory Syndrome
Rotavirus
Measles, Mumps
Common cold
Influenza
Gastrointestinal infections, acute
HIV ‐ AIDS
Herpes‐ Simplex
Oral‐ type 1
Genital‐ type 2
Zoster
Hepatitis A, B, C, D B = Most common form in the USA
CMV – Cytomegalovirus
Zika Virus
Ballachanda, B., Roeser, R., Kemp, R. (March 1996). American Journal of Audiology • Vol. 5 • No. 1
FUNGAL INFECTIOUS DISEASESFUNGAL INFECTIOUS DISEASES
Caused by fungi in the environment
There are approximately 1.5 million different species of fungi on Earth, but only about 300 make people sick.
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FUNGAL INFECTIOUS DISEASESFUNGAL INFECTIOUS DISEASES
Candida species
RingwormCryptococcus neoformans
Otitis Externa
INFECTIOUS DISEASES IMPORTANT TO AUDIOLOGY
DISEASE AGENT POTENTIAL TRANSMISSION INCUBATION PERIOD
POTENTIAL OUTCOME
AIDS Acquired Immune Deficiency Syndrome
Virus Blood to blood contact. Blood enters via something as simple as chapped hands
Average 8 years Death
Chicken Pox Virus Blood, saliva, or mucus (ear drainage); provide therapy for infected, subclinical child
10‐21 days Conjunctivitis, shingles, encephalitis
Common cold Virus Blood, saliva, mucus. Infected patient sneezes on surface. Employee touches counter, touches noise, then breathes on others in the office
48‐72 hours Temporary disability
Cytomegalovirus Virus Blood, saliva, mucus. Handling toys that infected child put in mouth.
2‐8 weeks Birth defects, death.
Hepatitis A Virus Oral, fecal; failure to wash hands after seeing infected patient
2‐7 weeks Disability, liver damage
Hepatitis B Virus Blood, saliva, mucus. Handling cerumen containing dried blood or saliva of “carrier” touches cut on hand. Bitten by carrier.
6 weeks‐6 months Chronic carrier, chronic disability, death
Hepatitis C Virus Blood transfusion 6 weeks‐6 months Death
Herpes Simplex‐ 1,6 Virus Blood, saliva, mucus, exudates from sores. Touch canker sore or infected saliva while providing therapy.
2‐12 days Discomfort, herpetic conjunctivitis or herpetic whitlow
Herpes zoster (shingles)
Virus Blood, saliva, mucus. Make contact with vesicle (blister)
6‐10 weeks Disability
Infectious mononucleosis
Virus Blood, saliva, mucus. Contact with infected’s saliva during therapy
4‐7 weeks Temporary disability
Influenza Virus Saliva, mucus, respiratory droplets. Provide service for infected patient
1‐3 days Temporary disability, death
Infectious meningitis Virus or bacteria
Blood, saliva, mucus. Contact with infected’s saliva during therapy, contact with infected ear drainage.
2‐10 days Disability, death
Legionellosis Bacteria Respiratory droplets. Therapy or otoscopic examination requires that clinician’s face comes close to patient’s face.
2‐10 days Temporary disability, death
Measles Virus Saliva, mucus. Saliva of infected person touches tongue depressor then is handled by the clinician who fails to wash hands prior to touching nose
9‐11 days Congenitatl defects, temporary disability, encephalitis
Mumps Virus Respiratory droplets 14‐25 days Temporary disability, serility (men)
Otitis externa Bacteria, fungus
Saliva, mucus, blood. Contact with microbes; handle ITE”s with bare hands, transferring fungus from patient to clinician
1‐2 days Itching, pain, swelling
Pediculosis (head lice)
Lice Lice transported from scalp via combs and hats; head phones could transfer lice from patient to patient
Eggs hatch 7‐10 dyas
Temporary discomfort, itching
Pneumonia Virus/bacteria
Blood, respiratory droplets. Varies with organism
Temporary disability, death
Staphylococcus Infection
Bacteria Saliva, mucus, contact with staph colony. Audiologist handles ear mold or speculum prior to disinfection. Scratched by infected person.
4‐10 days Skin lesions, death
Streptococcus infection
Bacteria Saliva, blood, mucus, respiratory droplets. Clinician touches instrument that enters mouth of infected
1‐3 days Heart & kidney problems, death
Tuberculosis Bacteria Respiratory droplets, saliva Up to 6 months Disability, death Kemp, R., Roeser, R., Pearson, D., Ballachanda, B.. Infection Control for the Professions of Audiology and Speech Language Pathology. (1996). Burns Printing.
INFECTIOUS DISEASES IMPORTANT TO AUDIOLOGY
DISEASE AGENT POTENTIAL TRANSMISSION INCUBATION PERIOD
POTENTIAL OUTCOME
AIDS Acquired Immune Deficiency Syndrome
Virus Blood to blood contact. Blood enters via something as simple as chapped hands
Average 8 years Death
Chicken Pox Virus Blood, saliva, or mucus (ear drainage); provide therapy for infected, subclinical child
10‐21 days Conjunctivitis, shingles, encephalitis
Common cold Virus Blood, saliva, mucus. Infected patient sneezes on surface. Employee touches counter, touches noise, then breathes on others in the office
48‐72 hours Temporary disability
Cytomegalovirus Virus Blood, saliva, mucus. Handling toys that infected child put in mouth.
2‐8 weeks Birth defects, death.
Hepatitis A Virus Oral, fecal; failure to wash hands after seeing infected patient
2‐7 weeks Disability, liver damage
Hepatitis B Virus Blood, saliva, mucus. Handling cerumen containing dried blood or saliva of “carrier” touches cut on hand. Bitten by carrier.
6 weeks‐6 months Chronic carrier, chronic disability, death
Hepatitis C Virus Blood transfusion 6 weeks‐6 months Death
Herpes Simplex‐ 1,6 Virus Blood, saliva, mucus, exudates from sores. Touch canker sore or infected saliva while providing therapy.
2‐12 days Discomfort, herpetic conjunctivitis or herpetic whitlow
Herpes zoster (shingles)
Virus Blood, saliva, mucus. Make contact with vesicle (blister)
6‐10 weeks Disability
Infectious mononucleosis
Virus Blood, saliva, mucus. Contact with infected’s saliva during therapy
4‐7 weeks Temporary disability
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Influenza Virus Saliva, mucus, respiratory droplets. Provide service for infected patient
1‐3 days Temporary disability, death
Infectious meningitis Virus or bacteria
Blood, saliva, mucus. Contact with infected’s saliva during therapy, contact with infected ear drainage.
2‐10 days Disability, death
Legionellosis Bacteria Respiratory droplets. Therapy or otoscopic examination requires that clinician’s face comes close to patient’s face.
2‐10 days Temporary disability, death
Measles Virus Saliva, mucus. Saliva of infected person touches tongue depressor then is handled by the clinician who fails to wash hands prior to touching nose
9‐11 days Congenitatl defects, temporary disability, encephalitis
Mumps Virus Respiratory droplets 14‐25 days Temporary disability, serility (men)
Otitis externa Bacteria, fungus
Saliva, mucus, blood. Contact with microbes; handle ITE”s with bare hands, transferring fungus from patient to clinician
1‐2 days Itching, pain, swelling
Pediculosis (head lice)
Lice Lice transported from scalp via combs and hats; head phones could transfer lice from patient to patient
Eggs hatch 7‐10 dyas
Temporary discomfort, itching
Pneumonia Virus/bacteria
Blood, respiratory droplets. Varies with organism
Temporary disability, death
Staphylococcus Infection
Bacteria Saliva, mucus, contact with staph colony. Audiologist handles ear mold or speculum prior to disinfection. Scratched by infected person.
4‐10 days Skin lesions, death
Streptococcus infection
Bacteria Saliva, blood, mucus, respiratory droplets. Clinician touches instrument that enters mouth of infected
1‐3 days Heart & kidney problems, death
Tuberculosis Bacteria Respiratory droplets, saliva Up to 6 months Disability, death Kemp, R., Roeser, R., Pearson, D., Ballachanda, B.. Infection Control for the Professions of Audiology and Speech Language Pathology. (1996). Burns Printing.
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VIDEO….
THE IMMUNE SYSTEM
THE IMMUNE SYSTEM REVIEWTHE IMMUNE SYSTEM REVIEW
Job of our body’s immune system is to defend our body from microorganisms in our environment
Bacteria Viruses
Parasites Fungi
Microorganisms are looking for a nice, WARM place to call home, settle down and build a large family of microorganisms
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http://www.encognitive.com/node/1114
IMMUNE SYSTEM REVIEWIMMUNE SYSTEM REVIEW
Two sub‐systems of
Immune System
1) Natural Immune System
2) Adaptive Immune System
IMMUNE SYSTEM REVIEWIMMUNE SYSTEM REVIEW
Natural Immune System First line of defense from attack
• Skin, mucus, stomach acid
Non‐specific immune response
• Responds the same way each time it is attacked regardless of what is attacking
Not 100% effective
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Body must rely on 2nd line of defense called the
ADAPTIVE IMMUNE SYSTEM
IMMUNE SYSTEM REVIEWIMMUNE SYSTEM REVIEW
Adaptive Immune System
Goal: Neutralize and kill the invading antigen
Defends and protects body
More complex system
Actively identifies, seeks and destroys antigens
IMMUNE SYSTEM REVIEW: ANATOMY
IMMUNE SYSTEM REVIEW: ANATOMY
Organs of Adaptive Immune Sysstem
Bone Marrow
Thymus
Lymph Nodes
Spleen
http://aspiruslibrary.org/illustrations/immune_system.htm
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IMMUNE SYSTEM REVIEW: LYMPHATIC SYSTEM
What is it? Network of vessels responsible for
channeling the lymphatic fluid to the lymph nodes.
Lymphatic fluid = clear, white fluid made up of mainly white blood cells (leukocytes)
IMMUNE SYSTEM REVIEW: LYMPHATIC SYSTEM
IMMUNE SYSTEM REVIEW: LYMPHATIC SYSTEM
What happens?Clear fluid that contains only white blood cells‐immune cells empties from lymph nodes into the blood stream
Cells travel through blood stream, pick up and then are re‐absorbed by organs & tissues
Immune cells flow continuously through the body.
Then immune cells are then re‐directed to flow back through the lymphatic system
IMMUNE SYSTEM REVIEW: LYMPHATIC SYSTEM
IMMUNE SYSTEM REVIEW: LYMPHATIC SYSTEM
An immune response detected in one area of the body will be
communicated throughout the body.
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IMMUNE SYSTEM
REV
IEW
IMMUNE SYSTEM
REV
IEW
Immune system uses the blood stream to travel throughout the body.
Erythrocytes (red blood cells)
Leukocytes
(white blood cells)
IMMUNE SYSTEM REVIEW
LYMPHOCYTES ‐ A special group of white blood cells carry out the activity
of adaptive immune system and protect body from infection.
B ‐ Lymphocite or B Cell
T ‐ Lymphocite or T Cell
IMMUNE SYSTEM REVIEW B‐CELLS
IMMUNE SYSTEM REVIEW B‐CELLS
Develops and matures in the bone marrow
Job (Referred to as Humoral Immunity):
Recognizes the presence of an antigen
Responsible for initiating production of antibody
Antibody=soluble protein which binds to, neutralizes and kills the antigen
Portion are memory cells
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IMMUNE SYSTEM REVIEWT‐CELLS
Development begins in bone marrow but matures in thymus
Job: (Cell Mediated Immunity)
Detect presence of antigen, binds itself to it and initiates neutralization
Communicates with B cells. Sends activation signal to B cells to mass produce antibody.
IMMUNE SYSTEM ‐ REVIEW
videoplayback_immune system.mp4
B ce l l sMass produce antibody specific to the antigen
identified by T cellsPortion are left as memory cells that remain in
circulation
T ce l l s
Finds antigen and attaches itself Sends out signal to B cells to release antibody
Lymphocy tes ac t i vated
T cells B cells
Microbe ente rs body
Immune system recognizes antigen
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CHAIN OF IN
FECTIO
NCHAIN OF IN
FECTIO
N
http://https://www.isopharm.co.uk/dental/chain‐infection/#
FACTORS INCREASE SUSCEPTIBILITY TO INFECTION
FACTORS INCREASE SUSCEPTIBILITY TO INFECTION
Age
Heredity
Cultural Practices
Nutrition
Stress
Rest, exercise and personal health habits
Inadequate defenses
Environmental
Immunization history
Medications and medical therapies
FACTORS THAT INCREASE THE TRANSMISSION OF INFECTION:
FACTORS THAT INCREASE THE TRANSMISSION OF INFECTION:
Inadequate hand washing
Inadequate sterilization/disinfection of patient care equipment
Inadequate cleaning/ disinfecting surfaces
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BREAKING THE CHAIN OF INFECTION…..
ESTABLISHING AN
INFECTION CONTROL PLAN
ESTABLISHING AN
INFECTION CONTROL PLAN
OSHA REQUIREMENTS ‐INFECTION CONTROL
OSHA REQUIREMENTS ‐INFECTION CONTROL
OSHA mandates that a written infection control plan is implemented for every health care office
• Important for safety in the workplace for employees and patients
Audiology practice/hearing aid dispensing office is regarded as a health care setting
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Every audiological setting must have an infection
control plan
Every audiological setting must have an infection
control plan
WRITTEN PLAN FOR INFECTION CONTROL
WRITTEN PLAN FOR INFECTION CONTROL
Consists of 6 Sections
1. Employee Classification
2. Hepatitis B vaccination
3. Training
4. Accidental Exposure & Follow up
5. Implementation Records
6. Post Exposure Plan and Records
WRITTEN PLAN FORINFECTION CONTROL
Consists of 6 Sections
2. Hepatitis B vaccination
3. Training
4. Accidental Exposure & Follow up
5. Implementation Records
6. Post Exposure Plan and Records
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WRITTEN PLAN:EMPLOYEE CLASSIFICATION
WRITTEN PLAN:EMPLOYEE CLASSIFICATION
Category I
Highest potential of exposure to infectious agents
Example: Hospital, physician’s office
Clinical audiologist
Hearing aid dispenser
Category II
Slightly less risk to exposure
Example: Hearing aid dispensing office
Clinical audiologist, hearing aid dispenser
Category III
Lowest risk to exposure
Administrative staff, front office staff, persons not in direct contact with patients
WRITTEN PLAN FOR INFECTION CONTROLWRITTEN PLAN FOR INFECTION CONTROL
Consists of 6 Sections
1. Employee Classification
3. Training
4. Accidental Exposure & Follow up
5. Implementation Records
6. Post Exposure Plan and Records
WRITTEN PLAN: HEPATITIS B VACCINATION
WRITTEN PLAN: HEPATITIS B VACCINATION
Hepatitis B (HBV)
Vaccination plan
Records
All Category I and II employees who have contact with blood and bodily fluids must be offered the HBV vaccination in the office at no charge
Employer needs to maintain records of the vaccination for the full duration of their employment plus another 30 years
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WRITTEN PLAN FOR INFECTION CONTROLWRITTEN PLAN FOR INFECTION CONTROL
Consists of 6 Sections
1. Employee Classification
2. Hepatitis B vaccination
4. Accidental Exposure & Follow up
5. Implementation Records
6. Post Exposure Plan and Records
WRITTEN PLAN : WHEN SHOULD UNDERGO TRAINING
WRITTEN PLAN : WHEN SHOULD UNDERGO TRAINING
Initial training
Offered when begin in the position
Fully trained individual on office policies
No minimum time limit
Annual training
Can be as sort as a 10 minute update
Re‐classification
Must undergo training within 90 days of re‐classification
Change in procedure (new or update)
Everyone must undergo training to know how to conduct the procedure
WRITTEN PLAN: WHAT SHOULD BE COVERED IN TRAINING
WRITTEN PLAN: WHAT SHOULD BE COVERED IN TRAINING
OSHA standards for training content
Modes of Transmission
Information on HBV vaccine
Location & use of protective equipment
Hand hygiene
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WRITTEN PLAN FOR INFECTION CONTROLWRITTEN PLAN FOR INFECTION CONTROL
Consists of 6 Sections
1. Employee Classification
2. Hepatitis B vaccination
3. Training
5. Implementation Records
6. Post Exposure Plan and Records
WRITTEN PLAN:ACCIDENTAL EXPOSURE & FOLLOW UP
WRITTEN PLAN:ACCIDENTAL EXPOSURE & FOLLOW UP
If someone is exposed to an infectious agent:
Map out a plan in case of accident :
Someone exposed to potentially infectious agent
Steps taken if exposure occurs
Implement treatment for specific exposure
Record of incident
Include circumstances of exposure, route of exposure, treatment plan and outcome.
WRITTEN PLAN FOR INFECTION CONTROLWRITTEN PLAN FOR INFECTION CONTROL
1. Employee Classification
2. Hepatitis B vaccination
3. Training
4. Accidental Exposure & Follow up
6. Post Exposure Plan and Records
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WRITTEN PLAN FOR INFECTION CONTROL
1. Employee Classification
2. Hepatitis B vaccination
3. Training
4. Accidental Exposure & Follow up
5. Implementation Records
WRITTEN PLAN: POST EXPOSURE PLAN AND RECORDS
WRITTEN PLAN: POST EXPOSURE PLAN AND RECORDS
Any exposure to blood borne pathogens require follow up
Rare in audiology clinic
According to OSHA: “If the exposure involves a percutaneous or mucous membrane exposure to blood or other bodily fluids or cutaneous exposure to blood when the worker’s skin is chapped, abraded or other broken, a specific follow up evaluation must occur.”
Goal of follow up is to confirm that disease has or has not been transferred.
WRITTEN PLAN FOR INFECTION CONTROL
1. Employee Classification
2. Hepatitis B vaccination
3. Training
4. Accidental Exposure & Follow up
6. Post Exposure Plan and Records
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WRITTEN PLAN: IMPLEMENTATIONWRITTEN PLAN: IMPLEMENTATION
First
Assess how each clinical procedure is currently delivered
Develop a comprehensive list of all services offered
Look at all services offered in that setting
PROTOCOLS: EVERYDAY CLINICAL PROCEDURES
PROTOCOLS: EVERYDAY CLINICAL PROCEDURES
Diagnostics
Otoscopy
Air Conduction
Bone Conduction
Immittance testing
Vestibular evaluations
Electrophysiological testing
Cerumen removal
Intraoperative monitoring
Hearing Aids
Earmold impressions
Custom earmold modifications
Listening checks
Dispensing hearing aids
Loaner hearing aids
Assistive devices
Hearing aid drop off service
WRITTEN PLAN: IMPLEMENTATIONWRITTEN PLAN: IMPLEMENTATION
Second
Identify how the procedures may need to be modified to meet the goal of an effective infection control plan to minimize the spread of disease
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In developing implementation protocols, must take into
account any and all
guidelines that are outlined in standard precautions/universal
precautions
STANDARD PRECAUTIONS STANDARD PRECAUTIONS
Used to be known as Universal Precautions
Hand Hygiene
Isolation precautions ‐ use of personal protective equipment (e.g., gloves, gowns, masks),
Safe injection practices
Safe handling of potentially contaminated equipment or surfaces in the patient environment,
Respiratory hygiene/cough etiquette.
STANDARD PRECAUTIONS‐WORK PRACTICE PROTOCOLS STANDARD PRECAUTIONS‐
WORK PRACTICE PROTOCOLS
Isolation precautions ‐ use of personal protective equipment (e.g., gloves, gowns, masks),
Safe injection practices
Safe handling of potentially contaminated equipment or surfaces in the patient environment
Respiratory hygiene/cough etiquette.
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STANDARD PRECAUTIONS HAND HYGIENE
STANDARD PRECAUTIONS HAND HYGIENE
Hand hygiene is most important practice to prevent spread of infections organisms in healthcare industry
First line of defense against germs
• Hand washing with soap & water
• Use of alcohol‐based products (gels, rinses, foams) that do not require the use of water.
STANDARD PRECAUTIONS HAND HYGIENE
Wash hands
Before and after each patient
Before/after glove removal
If hands are visibly dirty
After handling or touching objects that have possibility to be contaminated
• e.g. with saliva or secretions from respiratory system)
SELF‐REPORTED FACTORS FOR POOR ADHERENCE WITH HAND HYGIENESELF‐REPORTED FACTORS FOR POOR ADHERENCE WITH HAND HYGIENE
Handwashing agents cause irritation and dryness
Sinks are inconveniently located/lack of sinks
Lack of soap and paper towels
Too busy/insufficient time
Understaffing/overcrowding
Patient needs take priority
Low risk of acquiring infection from patients
Adapted from Pittet D, Infect Control Hosp Epidemiol 2000;21:381‐386
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RECOMMENDED HAND HYGIENE TECHNIQUERECOMMENDED HAND HYGIENE TECHNIQUE
Handsanitizers – Apply to palm of one hand, rub hands together
covering all surfaces until dry
– Volume of product needed: based on manufacturer
Handwashing Wet hands with water, apply soap, rub hands together for at least
15 seconds
Rinse and dry with disposable towel
Use towel to turn off faucet
Guideline for Hand Hygienen Health-care Settings. MMWR 2002; vol. 51, no. RR-16.
STANDARD PRECAUTIONSHAND HYGIENE
STANDARD PRECAUTIONSHAND HYGIENE
Approved alcohol‐based products for hand
disinfection are preferred over antimicrobial or plain soap and water
• Due to superior microbiocidal qualities
• Reduces drying of the skin
• Convenience (on the go uses)
However, if your hands are visibly dirty, use soap/water.
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STANDARD PRECAUTIONS HAND HYGIENE
STANDARD PRECAUTIONS HAND HYGIENE
Store liquid sanitizer in closed containers
• Do not top off the containers
Use liquid soap
• Bar soap sits and has potential to collect germs
Lotions
• Frequent hand washing/antibacterial lotions and glove use wreck havoc on skin
Dry skin has higher potential to crack‐ pathway into body for pathogens
• During work day use water based lotions
Lubriderm, Lubriderm drug store brand, some Neutrogena products, CeraVe
STANDARD PRECAUTIONS HAND HYGIENE
Artificial nails in healthcare
STANDARD PRECAUTIONS HAND HYGIENE
Artificial or long nails
• Individuals wearing artificial nails have been shown to harbor more pathogenic organisms on the nails and in the subungual area than those with natural nails.
• Not recommended for health care professionals working with high risk patients
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Fingernails and Artificial NailsFingernails and Artificial Nails
Natural nail tips should be kept to ¼ inch in length
Artificial nails should not be worn when having direct contact with high‐risk patients
• (e.g., ICU, OR)
Guideline for Hand Hygiene in Health‐care Settings. MMWR 2002; vol. 51, no. RR‐16.
CDC. Frequently Asked Questions‐ Hand Hygiene
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STANDARD PRECAUTIONS‐WORK PRACTICE PROTOCOLS STANDARD PRECAUTIONS‐
WORK PRACTICE PROTOCOLS
Hand Hygiene
Safe injection practices
Safe handling of potentially contaminated equipment or surfaces in the patient environment
Respiratory hygiene/cough etiquette.
STANDARD PRECAUTIONS ISOLATION PRECAUTIONSSTANDARD PRECAUTIONS ISOLATION PRECAUTIONS
Isolation Precautions
or
Use of rotective ersonal quipment
Gloves
Gowns
Face masks, respirators,
Goggles and face shields
STANDARD PRECAUTIONS ISOLATION PRECAUTIONSSTANDARD PRECAUTIONS ISOLATION PRECAUTIONS
Selection of the type of equipment is based on:
• The nature of the patient interaction
• Potential for exposure to blood, body fluids or infectious agents.
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USE OF PPE IN AUDIOLOGYUSE OF PPE IN AUDIOLOGY
Gown• To protect skin and clothing during procedures or activities where contact
with blood or body fluids is anticipated
During ENG
Masks, eye goggles• Used during procedures that are likely to generate splashes or sprays of
blood or other body fluids.
Modification of hearing aids/ear molds
Hand hygiene • Final step after removing and disposing of PPE
USE OF PPE IN AUDIOLO
GY
USE OF PPE IN AUDIOLO
GY GLOVES!!!
Types:
Prior to using latex: • Need to ask if patient has an allergy
• Be aware if using lotions‐ petroleum based lotions weaken latex gloves
Nitrile‐ preferred in audiology setting • Able to use with impression material
• Less permeable and resistant to chemicals
Studies have shown that vinyl gloves have higher failure rates than latex or nitrile gloves when tested under simulated and actual clinical conditions
Latex Nitrile Vinyl
Which one is the correct fitting glove?
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ARE YOU WEARING THE CORRECT SIZE GLOVE?ARE YOU WEARING THE CORRECT SIZE GLOVE?
To measure: You want to measure around the knuckles of your dominant hand (above the V of your thumb).
If you have a measurement of 8 inches, you would wear a size 8 glove or perhaps an 8 ½ to be safe.
Many glove brands convert number sizes into XS, S, M, L and XL sizes.
PROPER GLOVE REMOVAL
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STANDARD PRECAUTIONS
Hand Hygiene
Isolation precautions ‐ use of personal protective equipment (e.g., gloves, gowns, masks),
Safe handling of potentially contaminated equipment or surfaces in the
patient environment,
Respiratory hygiene/cough etiquette.
STANDARD PRECAUTIONS
Hand Hygiene
Isolation precautions ‐ use of personal protective equipment (e.g., gloves, gowns, masks),
Safe injection practices
Respiratory hygiene/cough etiquette.
STANDARD PRECAUTIONS‐SAFE HANDLING OF CONTAMINATED ITEMS
CERUMEN
Use disinfectant wipes or tissue
Throw in garbage can or waste disposal basket ‐ infectious waste remains present once item is disposed of
Make a designated trash bin for contaminated items
• Do not anyone going through the garbage by chance and risk contamination
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STANDARD PRECAUTIONS‐SAFE HANDLING OF CONTAMINATED ITEMS
Excessive cerumen, mucus, vomit• Laceration during ear impression, wax removal• Otodam covered in blood• Patient vomited during ENG
Items must be disposed of separately Should have a dedicated garbage can
lined with plastic liner for such Double bag contaminated item Set aside
STANDARD PRECAUTIONS
Hand Hygiene
Isolation precautions ‐ use of personal protective equipment (e.g., gloves, gowns, masks),
Safe injection practices,
Safe handling of potentially contaminated equipment or surfaces in the patient environment,
COUGH ETIQUETTECOUGH ETIQUETTE
This is targeted to patients and accompanying family members with undiagnosed and transmittable sicknesses
Applies to any person with signs of illness Cough, cold, strep throat, fever, diarrhea
In waiting/reception areas
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COUGH ETIQUETTE
CDC states Cough Etiquette:
1. Education of healthcare facility staff, patients, and visitors
2. Posted signs, in language(s) appropriate to the population served, with instructions to patients and accompanying family members or friends;
3. Source control measures (e.g., covering the mouth/nose with a tissue when coughing and prompt disposal of used tissues, using surgical masks on the coughing person when tolerated and appropriate
COUGH ETIQUETTE CONTINUED…
4. Hand hygiene after contact with respiratory secretions
5. Spatial separation, ideally >3 feet of persons with respiratory infections in common waiting areas when possible.
6. Covering sneezes and coughs and placing masks on coughing patients are proven means of source containment that prevent infected persons from dispersing respiratory secretions into the air.
Now you have a written infection control plan….
Now how do you implement it?
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MAINTAINING ENVIRONMENTAL INFECTION CONTROL
MAINTAINING ENVIRONMENTAL INFECTION CONTROL
All surfaces that are re‐used are
required to be either:
Cleaned
Disinfected
Sterilized
MAINTAINING ENVIRONMENTALINFECTION CONTROL
Clean?
Disinfect?
Sterilize?
CLEANING VS DISINFECTING VS STERILIZATION
Cleaning
Removes the gross contamination of an object without killing germs
Important precursor to disinfecting/sanitizing
Risk for cross contamination must be removed by cleaning items first
Achieved with a brush, wipe or ultrasonic machine
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CLEANING VS DISINFECTING VS STERILIZATION
Disinfecting
Kills a specific number of germs
Number of germs killed is determined by the disinfectant used.
Audiology practice settings should use a HOSPITAL GRADE disinfectant. (Rutala, 1990)
Towelette, spray, soaking, or ultrasonic machine
CLEANING VS DISINFECTING VS STERILIZATION
Disinfecting
Commercial products are available that will not affect plastic, silicone rubber and acrylic
Rubbing alcohol is a disinfectant.
Rubbing alcohol is NOT recommended in an audiological setting as it will degrade materials often found in an an audiology clinic setting
Ultrasonic cleaners
Variety available
Different features available
temperature, timers
All used to disinfect
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CLEANING VS DISINFECTING VS STERILIZATION
Dwell time
Amount of time a disinfectant/sterilant must be in contact and visibly wet on a surface to in order to kill the specific microbes indicated.
Dwell time is product specific.
Check the label for the dwell times of the products in the office.
CLEANING VS DISINFECTING VS STERILIZATION
Sterilization Kills 100% of the vegetative microorganisms and their endospores 100% of the time. (Infection Control in Audiology Practice, 2003)
If not completely eliminated, microbes have the potential to return to spore form. While in spore form, it is much more resistant to sterilization
If spore is not killed, it may become vegetative and cause disease.
CLEANING VS DISINFECTING VS STERILIZATION
Sterilization is indicated:
When an object is contaminated with potentially infectious material
Blood, Mucous, other bodily fluids
When Objects that can potentially break the skin must be sterilized prior to re‐use Curettes, wax loops
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STERILIZATION IN AUDIOLOGY PRACTICE
Ways to sterilize
Heat under pressure (Autoclave)Uses high pressure saturated steam (121°C/249°F) for 15‐20 minutes
Can melt many items and instruments used in an audiology practice
STERILIZATION IN AUDIOLOGY PRACTICE
Cold Sterilization Soak instruments in
2% glutaraldehyde
or
7.5% hydrogen peroxide
These are only chemicals approved for sterilization
Cold sterilization
is the preferred method
for an Audiology practice
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STERILIZATION WITH WAVICIDESTERILIZATION WITH WAVICIDE
Eye protection should be worn when handling
Objects sterilized must be rinsed thoroughly
Porous items cannot be soaked
Can be re‐used for 28 days
A Glutaraldehyde solution which does not need to be mixed
10 hour soaking time
Store in a tightly covered soaking tray
Use gloves when handling
STERILIZATION WITH WAVICIDESTERILIZATION WITH WAVICIDE
Wavicide Disposal Disposed by pouring down drain with water running (dilution)
Biodegradable when diluted to a level such that it is not microbicidal
Controversial issue‐ some feel diluting and sending down drain is a biohazard.
According to MSDS sheet: “No usual restrictions on disposal. Some local governments may restrict the amounts of aldehydes that can be flushed down the drain. In localities where drain disposal is restricted the product may often be neutralized with glycine or sodium bisulfate and then flushed down drain.”
STERILIZATION WITH SPOROXSTERILIZATION WITH SPOROX
Less controversial in disposal‐
According to MSDS sheet:
“Dispose of in accordance with local, state and federal regulations. Do not reuse empty container. Rinse empty container thoroughly with water. Discard in trash. “
Hydrogen peroxide solution (7.5% or greater concentration
6 hour soaking time
Re‐used for 21 days
Less hazardous to use clinically than Wavicide
Use gloves to handle
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With all of the chemicals, we need to keep track of
What chemicals are in the office
How to store them
What do in case of an accident with the chemicals
Material Safety Data Sheets (MSDS) will supply this information.
MSDS SHEETSMSDS SHEETS
WHAT ARE THEY?
Information labels for every potentially hazardous chemical found in the office
WHY NEED THEM?
Important part of infection control plan
Must be kept accessible in case of accident to provide information on how to handle the chemical in question
MSDS SHEETSMSDS SHEETS
WHERE DO I GET THEM?
Obtained from manufacturer of the chemical.
WHERE NEED TO KEEP THEM?
OSHA requires that forms are stored near to the chemicals
Required to have MSDS Sheets for each item in office
Impression material, earmold glues, Wavicide, Sporax, Otoease, etc.
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Prior to disinfecting or sterilizing instruments, must clean all items
REMEMBER!!!!
WEAR GLOVES while cleaning/disinfecting
AND
WASH HANDS after glove use
CLEAN, DISINFECT OR STERILIZE??CLEAN, DISINFECT OR STERILIZE??
Be sure to clean everything
Use your common sense
Wipe down counters, chairs, tables, desk, workspaces, testing areas multiple times a day after patient use.
Must clean an item prior to disinfecting or sterilizing
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CLEAN, DISINFECT OR STERILIZE??CLEAN, DISINFECT OR STERILIZE??
What should I If an item:
comes in contact with a patient, but
does not touch blood orinfectious substances,
or the item cannot potentially break the skin
CLEAN, DISINFECT OR STERILIZE??CLEAN, DISINFECT OR STERILIZE??
What to ??
All items that come into contact with a patient; that can potentially touch an
infectious substance, or open wound
SPAULDING CRITERIA: APPROACH TO DISINFECTION & STERILIZATION
SPAULDING CRITERIA: APPROACH TO DISINFECTION & STERILIZATION
Dr. Earl Spalding (1972) developed a method of classifying medical instrumentation and equipment
Classification of instruments into three separate categories:
1. Critical Items
2. Semi‐critical Items
3. Non Critical Items
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SPAULDING CRITERIA: APPROACH TO DISINFECTION & STERILIZATION
SPAULDING CRITERIA: APPROACH TO DISINFECTION & STERILIZATION1. Critical Items
Items that come into contact with any sterile tissue or blood stream
High risk of infection if contaminated
Surgical instruments, catheters, implants, etc
2. Semi‐critical Items
Contact mucus membranes or non‐intact/broken skin, blood present
Anesthesia equipment, endoscopes, laryngoscope blades,
Require high level disinfection using chemical disinfectants.
3. Non Critical Items
Contact intact skin
Patient care items – blood pressure cuffs, crutches,
Environmental surfaces – bed rails, bedside tables, patient furniture, floors.
SPAULDING CRITERIA:
Audiology Practices/Clinics :
SEMI CRITICAL ITEMS
Require high level of disinfection
Curettes, specula, probe tips, ear molds, hearing aids, iPod earphones – with cerumen/blood present
NON‐CRITICAL ITEMS
Curettes, specula, probe tips, ear molds, hearing aids, iPod earphones – with no cerumen/blood present
CLEA
N, DISIN
FECTOR STER
ILIZE??
Surfaces in work areas• Patient touch areas
• Entire examination chair and armrest, exam table, desks, door knobs, reception counters, waiting room chairs, pens
• Toys• Toys should be non‐porous
• Plastic is easier to disinfect than wood, fuzzy toys, metal surfaces
• Toys should be disinfected daily – waiting room toys or play toys
• Hearing aid work areas• Repair benches
• Where hearing aids/ear molds are cleaned
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DISINFECTION PRACTICES IN AUDIOLOGYDISINFECTION PRACTICES IN AUDIOLOGY
Hearing aid listening stetho‐sets (the bell & ear tips) after each use
HA’s prior to attaching to 2cc coupler
Fun‐Tak is single use –should be replaced after each use
Earmolds
Hearing Aids
Supra‐aural headphones
Probe tips
ABR/ENG electrodes• that are not contaminated with
body fluids
Hearing aid cleaning tools • brushes, wax loops
EXAMPLES OF DISINFECTANTSEXAMPLES OF DISINFECTANTS
Audiologist’s Choice Disinfectant
http://aubankaitis.com/?p=2496
MicrobanDisinfectant Spray
Clorox Healthcare Hydrogen Peroxide Disinfectant Wipes
or Spray
WHAT TO CLEAN, DISINFECT OR STERILIZE??
Sterilize
Any items likely to break the skin or come in contact with blood/mucus
• Curette• Probe tips, OAE probe tips, otoscope specula
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CERUMEN’S POTENTIAL DIRTY SECRET…CERUMEN’S POTENTIAL DIRTY SECRET…
Cerumen is not typically thought of as an infectious substance• Color and viscosity make it difficult to determine if
blood or mucus is present. • May potentially contain blood, dried blood or
mucus
As a precaution, need to treat ALL cerumen as infectious and take necessary precautions
DISPOSABLES VS MULTIPLE USE
Should you use disposables?
• This is a debate that needs to be settled in your office
• Need to weigh the pros/cons issues
• Is it easier to use cold sterilization?
• More cost effective to use disposable?
Single use/disposable items
should be used
as designed…..
Designed as…
SINGLE USE ONLY!
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TYPICAL SIN
GLE U
SE ITEMS
Otoscope specula
Immittance probe tips
OAE probe tips
Ear mold impression syringe tips
Insert headphones
Headphone covers
Probe‐microphone tubes
ITEMS TO THINK ABOUT IN EVERYDAY USE….
HEARING AIDS
EARMOLD/HEARING AID MODIFICATION UNITS
ENG GOGGLES
BSER/ABR SILVER CUPS
HEADPHONES (TDH‐39)
Any instrumentation that makes into physical contact with the patient must be cleaned and
disinfected after each use.
INFECTION CONTROL– PATIENT EDUCATIONINFECTION CONTROL– PATIENT EDUCATION
Infection control is not just audiologist’s responsibility.
Patients should be instructed proper cleaning regimen for their hearing aids.
Patients must be instructed to clean and disinfect their
hearing aids/ear molds daily
ESPECIALLY those patients who have and are prone to have outer ear infections/fungus
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DAILY HEARING AID CLEANING REGIMENDAILY HEARING AID CLEANING REGIMEN
Daily routine after removing the aids:
• Wipe hearing aids with tissue
• Wipe aid/mold with a non‐alcohol based disinfectant towelette/spray
• Do not use alcohol, solvents or cleaning agents on hearing aids
DAILY HEARING AID CLEANING REGIMENDAILY HEARING AID CLEANING REGIMEN
Patient’s should be aware of where placing or storing their hearing aids
• Should not casually put on table, in pocket, thrown in to a purse, put in their mouth,
After daily use they should be cleaned and stored appropriately
• Cleaned with dry tissue,
• Non‐alcohol based disinfectant
How do you accept
your patient’s hearing aid?
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DAILY HEARING AID CLEANING REGIMENDAILY HEARING AID CLEANING REGIMEN
In the office , always accept hearing aid from the patient with
Dixie cup
With gloves
With tissues
Never accept a hearing aid with your bare hand!!!
INFECTION CONTROL:A WALKTHROUGH THE OFFICE
INFECTION CONTROL:A WALKTHROUGH THE OFFICE
Reception
Hearing aids
Hearing aid workroom
ENG
ABR
Booth
Counseling area
EXAMPLES OF EVERYDAY CLINICAL PROCEDURES
Diagnostics
Otoscopy
Air Conduction
Bone Conduction
Immittance testing
Vestibular evaluations
Electrophysiological testing
Cerumen removal
Intraoperative monitoring
Hearing Aids
Earmold impressions
Custom earmold modifications
Listening checks
Dispensing hearing aids
Loaner hearing aids
Assistive devices
Hearing aid drop off service
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A B
C D
A B
C D
WHERE TO GET INFECTION CONTROL MATERIALS…
Oaktree Products
Westone
HalHen
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REFERENCES
Infection Control in Audiology Practice. (2003) Audiology Today, 15:5,
Rutala, W.A. (1990). APIC guideline for selection and use of disinfectants. American Journal of Infection Control, 17:52, 99‐117.
American Academy of Audiology Code of Ethics‐ Part 1, Principle 2, Rule 2B
http://www.cdc.gov/fungal/diseases/index.html
Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008www.cdc.gov/hicpac/disinfection_sterilization/2approach.html
Infection Control: Best Clinical Practices, Course #20864, Audiology Online
GUIDE TO INFECTION PREVENTION FOR OUTPATIENT SETTINGS: Minimum Expectations for Safe Care. Website: www.cdc.gov/HAI/pdfs/guidelines/Outpatient‐Care‐Guide‐withChecklist.pdf
www.en.wikipedia.org/wiki/Cryptococcus_neoformans
http://en.wikipedia.org/wiki/Candida_%28fungus%29
REFERENCES
Bolyard, Elizabeth A, RN MPH, Ofelia C. Tablan, MD, Walter W. Williams, MD, Michele L. Pearson, MD, Craig N. Shapiro, MD, Scott D. Deitchman, MD, and The Hospital Infection Control Practices Advisory Committee Guideline for infection control in health care personnel, 1998 www.cdc.gov/hicpac/pdf/InfectControl98.pdf
Bankaitis, A (2014, October). Infection Control‐ What to do and How to do it. Audiology Online, Article 12953. Retrieved from Audiology Online.
Bankaitis, A. (2012, June). Infection Control Part II: What Audiologists Need to Do. Retrieved from Audiology Online.
Guideline for Hand Hygiene in Health‐Care Settings Recommendations of the Healthcare Infection Control Practices Advisory Committee and the CPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. October 25, 2002/Vol. 51/ No. RR‐16. http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf
Infection Control. Frequently asked Questions. Hand Hygiene. www.cdc.gov/oralhealth/infectioncontrol/faq/hand.htm
Bankaitis, A.U.. Infection Control – Why Do Audiologists Need to Care. Audiology Online. www.audiologyonline.com/articles/infection‐control‐why‐audiologists‐need‐12916.
http://www.rnpedia.com/nursing‐notes/fundamentals‐in‐nursing‐notes/asepsis‐and‐infection‐control/#
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REFERENCES Sample infection control plan.
http://eo2.commpartners.com/users/audio/downloads/Sample_Infection_Control_Plan_Handout.pdf#page=1&zoom=auto,‐74,798
Sporox v. Glutaraldehyde. Q & A. Retrieved from Audiology Online. www..audiologyonline/ask‐the‐experts/sporoxv‐glutaraldehyde
Ballachanda, B., Roeser, R., Kemp, R. (1996). Control and Prevention of Disease Transmission in Audiology Practice. American Journal of Audiology • Vol. 5 • No. 1, March 1996.
http://www.encognitive.com/node/1114
http://www.nlm.nih.gov/medlineplus/immunesystem.html
Guide to Prevention and Control of Infectious Diseases in the Workplace (2007). British Columbia Public Service Agency, British Columbia Government and Services Employees Union.
http://aubankaitis.com/?p=2496
https://www.youtube.com/watch?v=TxU8c4vEHWk
Adapted from Pittet D, Infect Control Hosp Epidemiol 2000;21:381‐386.
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WELCOMETO
LISHA
NY State & Federal Law Regulations and Professional Conduct for Hearing
Aid Dispensers
MarieAnn Zumpone‐Weibley AuD, CCC‐AJune 4th, 2018
Current Legislation
▪ There have been attempts over the past years to change NYS Hearing Aid law to allow for the sale of hearing aids for profit by physicians. Currently S3488/A195 are attempting to change the law.
▪ https://www.nysenate.gov/legislation/bills/2017/A195
▪ NYS Speech Language and Hearing Association has been the driving force behind opposition to these bills. Information on the current status of these bills can be found on the NYSSLHA website.
▪ www.nysslha.org
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HR 2276/S2575 –Audiology Patient Choice Act of 2017/18
▪ Introduced into Congress May 1, 2017 and into the senate March 20, 2018 This bill is designed:
▪ “To amend title XVIII of the Social Security Act to provide for treatment of audiologists as physicians for purposes of furnishing audiology services under the Medicare program, to improve access to the audiology services available for coverage under the Medicare program and to enable beneficiaries to have their choice of a qualified audiologist to provide such services, and for other purposes.”
▪ Both bills can be obtained here:
▪ https://www.congress.gov/bill/115th‐congress/house‐bill/2276/text?r=6
▪ https://www.congress.gov/bill/115th‐congress/senate‐bill/2575
Why are we here?This purpose of this course is to provide the required information to meet the NYS mandated continuing education for NYS Regulations
relating to Hearing Aid Dispensing
Hearing Aid Advisory Board▪ Professional Members
▪ 2 Otolaryngologists
▪ 4 Non‐Audiologist Dispensers
▪ 4 Dispensing Audiologists
▪ Public Members
▪ 1 member over 50 years of age
▪ 1 member who is a hearing aid user
▪ 1 member
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Have you read this information???NYS Registration of Hearing
Aid Dispensers
▪ Article 37‐A General Business Law
▪ Sections 788 through 805
New York State Education Law
▪ Section 8208
NYS Hearing Aid Dispensers Rules and Regulations Title 19 NYCRR, Part 192
Who are we talking about??▪ Audiologists
▪ Non‐Audiologist Hearing Aid Dispensers
▪ Audiology Graduate Students
▪ Hearing Aid Dispenser Trainees
▪ According to the law: Any person who is actively involved in the “fitting, selecting, renting, adapting, or servicing of hearing aids or any other instrument to compensate for impaired hearing.”
What Are the Basic Requirements?
▪ Obtain a Hearing Aid Dispenser License (for an Individual)
▪ Audiologists licensed by the NY Department of Education must take a practical Hearing Aid Dispensers exam which includes: taking an earmold impression and counseling patient
▪ Audiology Graduate Students – MUST obtain a trainee license and be supervised by an Audiologist/Hearing Aid Dispenser who holds an Hearing Aid Dispenser Instructor License.
▪ Must be obtained prior to Off Campus training
▪ Supervisor can either be a the University’s Supervising Instructor OR the designee (site supervisor who is involved in the dispensing of hearing aids)
▪ Can either WAIT until NYS Audiology license is obtained OR complete written and practical examination to obtain hearing aid dispenser license prior to completion of AuD program
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▪ Non‐audiologist hearing aid dispensers
▪ MUST be supervised by a HA Dispenser Instructor
▪ Follow the curriculum set forth by the Department of State Bureau of Education Standards
▪ Includes 155 hours of theory
▪ 310 hours of practical
▪ 1 year of supervised training
MUST pass both a written and practical examination
▪ Obtain required Continuing Education hours dependent upon designation
Hearing Aid Dispensers who are also Audiologists licensed by the Department of Education must complete four hours of hearing aid dispenser related topics in which at least two hours must include the topic of infection control and at least one hour must include New York State and Federal law, regulations and professional conduct. Such hours may be earned in satisfaction of continued licensure under article 159 of the Education Law, as long as the registrant demonstrates completion of the required topics.
All licensed Hearing Aid Dispensers must complete 20 hours of Department of State approved continuing education. At least two of these hours must include the topic of infection control and at least one hour must include New York State and Federal law, regulations and professional conduct. All courses must be approved by the Department of State.
Required Hearing Aid Dispensing Business Practices
▪ Business owner must be a licensed Hearing Aid Dispenser
▪ Must have a business license for each physical location
▪ Each individual must display their license in each location from which they dispense
▪ Subject to all the rules of NYS General Business Law
▪ Sec 798 Reg 192.11‐18 (http://www.dos.ny.gov/licensing/lawbooks/HearDispatch.pdf)
▪ Minimum equipment
▪ Testing booth (must meeting current ANSI standard)
▪ Audiometer
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▪ :Patient must receive a copy of the hearing test with must be labeled as follows
▪ If testing is done by an Audiologist
▪ “This is an audiological evaluation and is not a medical examination.”
▪ If testing is done by a Hearing Aid Dispenser
▪ “This information is intended for the sole purpose of fitting or selecting a hearing aid and is not a medical examination or an audiological evaluation.”
Patient Chart MUST include the following:(Must be maintained for 6 years demographic information does not
need to be updated)
▪ Patient History Questionnaire▪ Must include demographic information
▪ HIPAA/Disclosure statements
▪ Patient Encounter Sheet
▪ Medical Clearance form from a physician preferably an otolaryngologist stating the patient has been medically evaluated and is cleared for the use of amplification
▪ Physical Examination which must include otoscopy
▪ Must verify if the patient has any of the 8 Signs for medical referral
▪ Audiogram (should include the following except if explained in chart note)
▪ Pure tone Air & Bone Conduction testing with masking as indicated
▪ Speech Reception Thresholds/Speech Awareness Thresholds
▪ Speech Recognition Scores
▪ MCL and UCL
Purchase Agreement Form MUST include:
▪ Identifying information of Office, Address, Office Hours and Phone Number
▪ Dispenser and business registration numbers
▪ Date of Sale
▪ Make, Model, Serial Number of the Hearing Aid, Which Ear (Left/Right/Both), Color, Accessories, Warranty (Repair and Loss & Damage)
▪ New/Used/Reconditioned
▪ Total fees
▪ Statement regarding the use of hearing aids
▪ Statement regarding patient’s right to return hearing aids within 45 day trial period
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Statement regarding Patient’s Right to 45 Day Trial
MUST be in 12 point font immediately above patient signature area on Contract
“IN ADDITION TO OTHER RIGHTS, THE BUYER HAS THE RIGHT TO CANCEL THIS PURCHASE FOR ANY REASON AT ANY TIME PRIOR TO TWELVE MIDNIGHT OF THE 45TH CALENDAR DAY ( ‐‐/‐‐/20‐‐/ ) AFTER RECEIPT OF THE HEARING AID AND RETURN THE HEARING AID IN THE SAME CONDITION, ORDINARY WEAR AND TEAR EXCLUDED. BY LAW, THE SELLER IS ALLOWED TO RETAIN AN AMOUNT UP TO TEN PERCENT(10%) OF THE TOTAL PURCHASE PRICE OF THE CANCELLED HEARING AID INCLUDING BATTERIES AND CORDS OR ACCESSORIES THERETO, INCLUSIVE OF ALL FEES RELATED TO THE HEARING AID.”
EXCEPTION to 45 day return policy
“Within one year from the date of purchase, in addition to any other rights and remedies the purchaser of a hearing aid may have, the purchaser shall have the right to rescind the transaction if: (i) the purchaser consults a licensed otolaryngologist, or if no such licensed otolaryngologist is available then another licensed physician, qualified to diagnose diseases of the ear, subsequent to purchasing a hearing aid, (ii) and the physician certifies in writing that, in his or her professional judgement, at the time the dispensing occurred the purchaser had either a hearing impairment for which a hearing aid provides no benefit or had a medical condition which contraindicates the use of a hearing aid, and (iii) as a result of either condition, the purchaser experienced no improvement in the quality of hearing.”
State law requires you to be informed of the benefits of tele‐coil (or t‐coil) technology for hearing devices and t‐coil use in looped environments and with assistive listening devices https://www.dos.ny.gov/licensing/pdfs/TelecoilSign01.pdf
Requirement for posting :
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https://www.nysenate.gov/legislation/bills/2017/A519
Current legislation in NYS Assembly Bill A519:
“Requires Hearing Aid Dispensers to provide prospective purchasers of hearing aids with
information pertaining to audio switch technology”
Requirement for Medical EvaluationPosted on site in 40 point font
“Federal law requires a medical evaluation of your hearing loss by an otolaryngologist, or if none is available, by another licensed physician. You have the right to waive this requirement. If you waive this requirement, you must sign a statement of waiver of your rights”.
Waiver of Medical Evaluation
All patients are required to have medical clearance
▪ “at my request, (name of dispenser) has informed me that I may waive medical evaluation of my hearing due to my personal or religious beliefs, signed (name of prospective patient or parent or guardian)”
▪ Can only be used if patient is over 18 years old
▪ Should be at the patient’s request and not encouraged by the hearing aid dispenser.
This form must be signed & dated by both the patient and the dispenser.
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Statement regarding the use of hearing aidsMUST be in 14 point Font on the Contract
▪ “The purchaser has been verbally advised at the outset of his or her relationship with the registered hearing aid dispenser that any examination or representation made by a hearing aid dispenser in connection with the business of dispensing this hearing aid, or hearing aids, is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state, and therefore, must not be regarded as medical opinion.”
8 Signs Requiring Medical Referral
▪ Visible physical deformity of the external ear, external auditory canal or tympanic membrane
▪ Active drainage within the last 90 days
▪ Sudden or progressive hearing loss in the last 90 days
▪ Chronic or acute vertigo or dizziness
▪ Unilateral hearing loss occurring within the last 90 days
▪ Air‐Bone gaps of greater than 15 dB at 500, 1000 and 2000 Hz
▪ Otalgia, discomfort or aural fullness
▪ Visible evidence of bleeding, cerumen or foreign body in the ear canal
Repairs/Service
▪ Must accept any hearing aid, or accessory, you sold and/or rented for 5 years
▪ Repairs require customer approval (signature preferred)
▪ Patient must receive an Itemized receipt for all repairs
▪ If fee for estimate is charged, patient must be advised in writing
▪ All repairs must have a flat 30 day repair guarantee
▪ Loaners fees can be charged if the patient is advised, patient has the option to refuse loaner if a fee is required but cannot be refused service
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Advertising/Sales
▪ Hearing aids cannot be sold via catalog/website/telemarketing/door to door sales
▪ All advertising must be truthful as to claims of the benefits of the device.
▪ Hearing aid dispensers cannot claim Medical services as an Audiologist or Physician
▪ A file of all advertising should be maintained in the main office of the practice
▪ Claims made in advertising must be truthful
Consumers
▪ The role of a hearing dispenser is to educate the consumer not to deceive or force a sale.
▪ Consumers have the right to register a complaint with an office in the Department of State either in writing, person or via telephone.
▪ Consumers should be trained in the use and care of hearing instruments as well as
▪ Communication strategies
▪ Support group information
▪ Life expectancy of the hearing aid
▪ Extended warranty and loss/damage coverage
▪ Having a checklist signed by the patient ensures the dispenser and the consumer that all regulations regarding the hearing aid purchase have been met.
Hearing Aid Dispenser Law
http://www.dos.ny.gov/licensing/lawbooks/HearDispatch.pdf
“It is the responsibility of licensees to understand theHearing Aid Dispenser License Law”
Hearing Aid Dispenser Signs and Patient Handbook
▪ https://www.dos.ny.gov/licensing/pdfs/Proposed%20‐%20Long_ConsGuide_2017%20(updated%20version)_041117.pdf
▪ https://www.dos.ny.gov/licensing/pdfs/hear_aid_guide041117.pdf
▪ https://www.dos.ny.gov/licensing/pdfs/TelecoilSign01.pdf
Hearing Aid Dispenser Forms
http://www.dos.ny.gov/licensing/hearingaid/hearingaid.html
NYS Website Important Links:
5/30/2018
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QUESTIONS?????If you have addition questions please contact me directly at
[email protected] through the LISHA website