New York State Infection Control for Hearing Healthcare · 2018-06-04 · canker sore or infected...

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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


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 ‐


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


VECTOR BORNE


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.


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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g py

Influenza Virus Saliva, mucus, respiratory droplets. Provide service for infected patient


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.


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


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


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)



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



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


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



3. Training




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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



3. Training




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 : 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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3. Training



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.




3. Training



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3. Training



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.




3. Training



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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



Safe handling of potentially contaminated equipment or surfaces in the patient environment


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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.


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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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


Artificial nails in healthcare


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 handling of potentially contaminated equipment or surfaces in the patient environment


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


Safe handling of potentially contaminated equipment or surfaces in the

patient environment,



Hand Hygiene




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


Hand Hygiene


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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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


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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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.


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.


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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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


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


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 & 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


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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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:

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QUESTIONS?????If you have addition questions please contact me directly at

[email protected] through the LISHA website

New York State Infection Control for Hearing Healthcare · 2018-06-04 · canker sore or infected...

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