153rd IOWA DENTAL
ASSOCIATION ANNUAL SESSION
BrownWinick Law Firm
666 Grand Avenue, Suite 2000
Des Moines, IA 50309-2510
Website: www.brownwinick.com
BLOG: www.brownwinick.com/BLOGHealthLaw
OSHA, HIPAA, AND
LICENSURE REGULATIONS
Brenton D. Soderstrum: soderstrum@brownwinick.com
Catherine C. Cownie: cownie@brownwinick.com
Adam J. Freed: freed@brownwinick.com
Rebecca A. Brommel: brommel@brownwinick.com
Website: www.brownwinick.com
BLOG: www.brownwinick.com/BLOGHealthLaw
ARE YOU READY FOR YOUR
OSHA CHECKUP?
Brenton D. Soderstrum
BrownWinick
666 Grand Avenue, Suite 2000
Des Moines, IA 50309-2510
Telephone: 515-242-2474
Facsimile: 515-323-8574
E-mail: soderstrum@brownwinick.com
WHAT IS OSHA?
ANTICIPATE AN INSPECTION

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Make sure all workers know about safe
procedures
Safety Programs needed
How will you handle an inspection?
BLOODBORNE PATHOGEN
STANDARD

Protect employees who are at risk for
exposure to blood and bodily fluids
1. Hepatitis B vaccination
2. Training and information on bloodborne
pathogens
3. Personal protective attire
o
No cost to employees
4. Written safety plan, including exposure
control plan
HAZARD COMMUNICATION
STANDARD
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“Employee’s Right to Know” law
Ensure chemical safety in workplace
Information available about identities and
hazards of chemicals
Training, personal protective attire,
information for labeling containers of
chemicals and maintaining Material
Safety Data Sheets (MSDS)
GENERAL DUTY CLAUSE


“Furnish to each of his employees employment and
a place of employment free from recognized hazards
that are causing or likely to cause death or serious
physical harm to his employees.”
Requires “each employee to comply with
occupational safety and health standards and all
rules, legal actions and orders issued pursuant to
this Act, which are applicable to his own actions and
conduct.”
OSHA INSPECTION CHECKLIST
1. OSHA training should be conducted
annually and documented.
2. Documentation of training should be
kept for 3 years.
3. Hepatitis B vaccination should be
offered to clinical employees within 10
days of employment.
OSHA INSPECTION CHECKLIST
(CONT.)
4.
Documentation of immunity to hepatitis
B vaccination must be kept on file.
5.
If employee declines hepatitis B
vaccine, employee signature kept on
file.
6.
Keep OSHA manual updated
•
Do you have one?
OSHA INSPECTION CHECKLIST
(CONT.)
7. OSHA Poster?
8. Bloodborne Pathogen Standard?
9. Keep employee recordkeeping and
health forms on file.
OSHA INSPECTION CHECKLIST
(CONT.)
10. Keep recordkeeping and health forms for
the duration of employment PLUS 30
years.
11. Make sure eyewash station works
properly, has cold water only and that a
sign designates its location.
12. Keep fire extinguishers mounted on the
walls and fully charged.
OSHA INSPECTION CHECKLIST
(CONT.)
13. Keep emergency exits marked and
unobstructed.
14. Inspect office for unsafe work
conditions such as electrical and trip
and fall hazards.
15. Review evacuation plans and
protocols.
OSHA INSPECTION CHECKLIST
(CONT.)
16. A first aid kit should be available for
minor cuts and injuries.
17. Hand hygiene policies in place.
18. Exposure Incident Protocol is current
and reviewed annually.
OSHA INSPECTION CHECKLIST
(CONT.)
19. Provide Personal Protective
Equipment (PPE)
a. Clinical jacket
b. Protective eyewear
c.
Mask
d. Gloves (both exam and utility)
OSHA INSPECTION CHECKLIST
(CONT.)
20. No charge for personal protective attire.
21. Reusable clinical jackets should be
laundered and maintained by employer at
no charge.
22. Engineering controls, such as needle
recapping devices or safety syringes,
should be used.
OSHA INSPECTION CHECKLIST
(CONT.)
23. Annual review and evaluation of safer
sharps devices.
24. Work Practice Controls should be
employed to reduce risks when handling
sharps.
OSHA INSPECTION CHECKLIST
(CONT.)
25. Hazard Communication Standard
must be followed:
a.
Inventory of hazardous substances
b.
Organize Material Safety Data Sheets (MSDS)
for each hazardous substance
c.
Place labels on containers not identified
(secondary containers)
OSHA INSPECTION CHECKLIST
(CONT.)
25. Hazard Communication Standard
must be followed (cont.):
d. Inspect chemical containers for leaks.
e. Train employees on proper use of and handling of
hazardous substances.
f.
PPE for handling chemicals.
g. Training on chemical spills, disposal and cleanup.
OSHA INSPECTION CHECKLIST
(CONT.)
26. Sharps containers should be located
as close as possible to where sharps
are used. There must be a spill-proof
container, colored red or orange-red,
and it must be puncture-resistant and
have a biohazard label.
OSHA INSPECTION CHECKLIST
(CONT.)
27. Explain what labels, signs and
symbols mean (chemical, biohazard,
radiation, etc.)
28. Ergonomic Plan to reduce incidents of
musculo-skeletal injuries
BREAKDOWN OF OSHA
INSPECTION
1.
Opening Conference
2.
Inspection
a. Priority system
b. Questions
c. What inspector is looking for
3.
Closing Conference
WHAT HAPPENS AFTER THE
OSHA INSPECTION
1. Citations
2. Informal conference
3. Notice of contest
4. Complaint/Answer
5. Discovery
6. Hearing
QUESTIONS
HIPAA FOR THE
DENTAL PRACTICE
Catherine C. Cownie
Adam J. Freed
E-mail: cownie@brownwinick.com E-mail: freed@brownwnick.com
Telephone: 515-242-2490
Telephone: 515-242-2402
BrownWinick
666 Grand Avenue, Suite 2000
Des Moines, IA 50309-2510
Website: www.brownwinick.com
Questions to Ask
About Your Practice
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When was the last time you completed a HIPAA risk
assessment?
Do you have a written HIPAA compliance plan?
If you have a compliance plan, when was the last time you
reviewed it?
When was the last time you provided training to your
employees regarding HIPAA?
Other than your employees, who has access to your patients’
dental records?
Who is your Privacy Officer?
Who is your Security Officer?
Applicable Laws
• Rules of the Iowa Dental Board
• HIPAA
• Other Laws Applicable to Specific
Categories of Information
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Substance Abuse
Mental Health
HIV/AIDS
Employment
Iowa Dental Board Rules
27.11(2) Retention of records. A dentist shall
maintain a patient’s dental record for a minimum of
six years after the date of last examination,
prescription, or treatment. Records for minors shall
be maintained for a minimum of either (a) one year
after the patient reaches the age of majority (18), or
(b) six years, whichever is longer. Proper
safeguards shall be maintained to ensure safety of
records from destructive elements.
Iowa Dental Board Rules
• 27.11(3) Electronic record keeping. The
requirements of this rule apply to electronic
records as well as to records kept by any other
means. When electronic records are kept, a
dentist shall keep either a duplicate hard copy
record or use an unalterable electronic record.
Iowa Dental Board Rules
27.11(5) Confidentiality and transfer of records. Dentists shall
preserve the confidentiality of patient records in a manner
consistent with the protection of the welfare of the patient.
Upon request of the patient or patient’s legal guardian, the
dentist shall furnish the dental records or copies or summaries
of the records, including dental radiographs or copies of the
radiographs that are of diagnostic quality, as will be beneficial
for the future treatment of that patient. The dentist may charge
a nominal fee for duplication of records, but may not refuse to
transfer records for nonpayment of any fees.
HIPAA and HITECH
Health
Insurance
Portability and
Accountability
Act
Health
Information
Technology for
Economic and
Clinical
Health Act
HIPAA Applies to
“Protected Health Information”
“Protected Health Information”
includes any information that identifies a
patient, regardless of whether the
information seems private or sensitive.
“PHI” Includes Dental Records
Maintained Pursuant to
Iowa Dental Board Rules
The rules of the Iowa Dental Board require the
following in dental records:
• Name, date of birth, address and, if a minor, name of
•
•
•
parent or guardian.
Name and telephone number of emergency contact.
The patient’s dental and medical history.
When a patient presents with a chief complaint, dental
records shall include the patient’s stated oral health care
reasons for visiting the dentist.
“PHI” Includes Dental Records
Maintained Pursuant to
Iowa Dental Board Rules
The rules of the Iowa Dental Board require the
following in dental records (cont.):
• Chronological dates and descriptions of the following:
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Clinical examination findings, tests conducted, and a summary of all
pertinent diagnoses;
Plan of intended treatment and treatment sequence;
Services rendered and any treatment complications;
All radiographs, study models, and periodontal charting, if applicable;
Name, quantity, and strength of all drugs dispensed, administered, or
prescribed; and
Name of dentist, dental hygienist, or any other auxiliary, who performs any
treatment or service or who may have contact with a patient regarding the
patient’s dental health.
• Documentation of informed consent.
Who Must Comply with HIPAA?
Covered
Entities
Business
Associates
• Health plans
• Health care clearinghouses
• Health care providers who transmit health
information in electronic form
• A person who creates, receives, maintains,
or transmits protected health information on
behalf of a covered entity
• NOT a member of the covered entity’s
workforce
Likely Business Associates of
Your Dental Practice
•
•
•
•
•
•
•
Electronic dental record provider
Information technology support provider
Claims processor
Third-party billing company
Law firm
Accounting firm
Document shredding company
Business Associates Now Include
Subcontractors of Your Business Associates
A “business associate” includes “a
subcontractor that creates, receives, maintains,
or transmits protected health information on
behalf of the business associate.”
Who Must Comply with HIPAA?
(cont.)
“Covered Entity”
Lawyer’s
IT
Provider
Dental
Plan
Lawyer,
Patient
“Workforce Members”
Dentist
Employees
Accountant,
“Subcontractor
Billing Co.
Business
Associates”
“Business
Associates”
What Documentation Should a Dental
Practice Request from its Business
Associates?
A business associate must provide
“satisfactory assurances” that it will
appropriately safeguard the information.
The Business Associate provides the
satisfactory assurances in a
“Business Associate Agreement.”
So I’m Subject to HIPAA—Now
What Do I Do?
HIPAA requires covered entities and business
associates to implement administrative,
physical, and technical safeguards to ensure
the confidentiality, integrity, and availability of
electronic protected health information.
STEP 1:
Conduct a Risk Assessment
• HIPAA requires covered entities and business
associates to conduct “an accurate and thorough
assessment of the potential risks and
vulnerabilities to the confidentiality, integrity, and
availability of electronic protected health
information held by the covered entity or business
associate.”
• The risk assessment must be prepared in writing.
STEP 1:
Conduct a Risk Assessment
(cont.)
• Possible Vulnerabilities (not an exhaustive list):
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No off-site back-up of electronic PHI.
Lack of a Business Associate Agreement with one or more
business associates
Protected health information stored in unencrypted format
Insufficient user access controls to computer systems
containing PHI
Passwords taped to the side of monitors
Storage of PHI on portable devices that could be lost or stolen
Routine discussion of care with patients in area where other
patients are present (such as the waiting room)
Former employees have keys to the office or building.
Outdated anti-virus software.
Possible Vulnerabilities
Possible Vulnerabilities
STEP 2:
Correct Any Deficiencies Identified
• If your risk assessment
identifies any risks,
determine what steps
are necessary to
eliminate or minimize
the risk.
• Document the steps
you take to eliminate or
minimize the risk.
STEP 3:
Develop Written Policies and Procedures
• Establish protocols for your administrative, physical, and
technical safeguards, such as the following:

How often and where electronic PHI is backed up

Password content requirements and how often they must be
changed

Which workforce members have keys to the office

When and how training is provided to new and current
workforce members

Termination of access to PHI by former employees

Restrictions on use of portable devices for electronic PHI

Use of antivirus software
STEP 3:
Develop Written Policies and Procedures
(cont.)
• Specify processes for complying with your patients’ rights
under HIPAA, including their rights to:

Access their PHI

Amend their PHI

Obtain a list of disclosures of their PHI
• Establish a procedure to follow if you are unable to access
your electronic PHI
• Establish a procedure to follow in the event of a breach of
electronic PHI
• Establish a sanction policy for employees who fail to comply
with the policies and procedures
STEP 4:
Train Your Workforce on the Policies
and Procedures
• Provide initial training to all employees
upon adoption of the policy
• Include HIPAA training in the orientation
for new employees
• Periodically hold “refresher” courses for
current employees
• Periodically send out reminders to
employees
STEP 5:
Monitor Compliance with Policies and
Procedures and Revise as Necessary
Risk
Assessment
HIPAA
Compliance is an
Ongoing Process
Monitor
Compliance
Train
Workforce
Correct
Deficiencies
Implement
Procedures
HIPAA Example
• [Insert Video]
HIPAA Issues
Identified in the Example
• Elaine could have simply requested a
copy of her medical record from her
physician.
• Physician reviewing x-ray image in plain
view of everyone in the lobby.
• “Fake Erase”: The rules of the Iowa
Dental Board do not permit erasures or
white-outs in dental records. Changes
can only be made by drawing a single line
through the incorrect information and
initialing the change.
Consequences of Failing to
Comply with HIPAA and HITECH
• Discipline by Iowa Dental Board
• Must report breaches of PHI to HHS Office of Civil Rights
• Must report major breaches of PHI to local news media
• Civil penalties of $100 up to $50,000 per violation
depending on severity
• Criminal penalties of up to 10 years in prison for intentional
violations
• State Attorneys General can enforce HIPAA
• Damage to reputation and loss of confidence among
patients
Consequences of Failing to
Comply with HIPAA and HITECH
Recent Examples of
HIPAA Breaches
Recent Examples of
HIPAA Breaches
Recent Examples of
HIPAA Breaches
QUESTIONS
REGULATORY ISSUES
AFFECTING IOWA DENTISTS
REBECCA A. BROMMEL
BrownWinick
666 Grand Avenue, Suite 2000
Des Moines, IA 50309-2510
Telephone: 515-242-2452
Facsimile: 515-823-0452
E-mail: brommel@brownwinick.com
Presentation Overview
•
•
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Iowa Dental Board Basics
License Requirements
Scope of Practice
Supervision of Dental Hygienists &
Dental Assistants
• Sedation
• Advertising
What is the Iowa Dental Board?
• State agency
• Regulates dentistry, dental hygiene and
dental assisting
• 9 members
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2 dentists
2 dental hygienists
2 public members
Dental Board Purpose & Duties
• Protect public health, safety and welfare
• Administer, interpret and enforce
relevant law
Dental Board Functions
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Administer exams
Issue licenses, registrations, certificates and permits
Set standards for licenses, registrations, permits and con’t ed
Enforce Iowa law relating to dentists, hygienists and assistants
Investigate complaints
Conduct disciplinary hearings
Monitor compliance with Board orders
Adopt rules and establish standards
Board Committees – Dental
Hygiene
• Initially handle all matters related to
hygienists
• Make recommendations to Board
• Board must ratify recommendations, unless:
 Exceed Committee’s jurisdiction
 Creates undue financial impact on Board
 Not supported by the record
Board Committees – Anesthesia
Credentials Committee
• Peer review committee
• Chaired by Board member
• At least 6 licensed dentists, 4 of which hold deep or
moderate sedation permits
• Review applications and make recommendations to
Board
• Conduct site visits and report results to Board
• Perform professional evaluations and report to Board
Board Committees – Iowa
Practitioner Review Committee
• 3 Members appointed by Board Chair
• May include:
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E.D. or other Board staff
Practitioner free of addiction for 2 years and successful
completion of program
Physician/counselor with substance abuse/addiction
treatment expertise
Psychiatrist or Psychologist
Public Member
Board Committees – IPRC (cont.)
• Evaluates, assists and monitors recovery, rehab or
maintenance of those who self-report
• Advocates for practitioner and a means to protect
public
• Confidential process
• Impairment(s) at issue:
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alcohol or drug abuse, dependency or addiction
Mental or physical disorder or disability
does NOT include sexual addictions or disorders
• Can be deemed ineligible for program
What the Dental Board Does
NOT Do
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OSHA
Radiology Inspections
HIPAA Violations
Insurance or Medicaid
Professional Associations (IDA, IDHA,
IDAA)
License Requirements - Dentists
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By examination
By credentials
Expire August 31 of even-numbered years
Fee
Continuing Education – 30 hours/2 years
CPR
Child & Dependent Adult abuse training – 2
hours/5 years
License Requirements – Dental
Hygienists
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•
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By examination
By credentials
Expire August 31 of odd-numbered years
Fee
Continuing Education – 30 hours/2 years
CPR
Child & Dependent Adult abuse training – 2
hours/5 years
Registration Requirements –
Dental Assistants
• 6 months as Trainee or prior experience out of state OR
• Graduate of accredited DA program, high school grad and at
least 17 years old
• Completion of Board-approved exams on infection control,
hazardous materials and jurisprudence
• Expire August 31 of odd-numbered years
• Fee
• CPR
• Continuing Education – 20 hours/2 years
• Child & Dependent Adult abuse training – 2 hours/5 years
New Rule: Military & Veteran
Reciprocity
• Credit for military education, training or
service
• Veteran Reciprocity – unrestricted
license from another jurisdiction
• Application forms from Board
Scope of Practice - Dentists
• Diagnosing
• Treatment Planning
• Determining appropriateness of proposed dental
care
• Publicly profess to be dentist, dental surgeon or
skilled in science of dentistry
• Diagnose, treat or attempt to correct any disease,
condition, disorder, lesion, injury, deformity or defect
of oral cavity and maxillofacial area (teeth, gums, jaw
and associated structures and tissues)
Scope of Practice – Dentists
(cont.)
• Teeth whitening
• North Carolina Board of Dental
Examiners v. FTC
Scope of Practice – Dental
Hygienists
• Educational: individual patients and community
groups, training for nurses, school personnel,
institutional staff and agencies
• Therapeutic: oral prophylaxis, periodontal scaling
and root planing, removing/polishing hardened
excess restorative material, local anesthesia (with
permit), administer nitrous oxide, apply or administer
medicaments prescribed by dentist for periodontal
disease and caries
Scope of Practice – Dental
Hygienists (cont.)
• Preventative: pit and fissure sealants and other
medicaments for periodontal disease and caries,
fluoride rinse and sealant programs
• Diagnostic: review medical and dental histories,
perform oral inspection, index disease, make
occlusal registrations for mounting study casts, pulp
vitality, analyze dietary surveys
Scope of Practice – Dental
Hygienists (cont.)
• Delegation by dentist required for:

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administration of local anesthesia
placement of sealants
Removal of plaque, stain, calculus or hard natural
or synthetic material except by toothbrush, floss
or rubber cup coronal polish
Scope of Practice – Dental
Assistants
• Procedures for which DA has received
training
• Delegation by dentist based upon best
interest of patient
Scope of Practice – Dental
Assistants (cont.)
• Limits on delegation by dentist
 Diagnosis, examination, treatment planning or prescription
 Surgical procedures on hard and soft tissues within oral cavity and
any other intraoral procedure that results in irreversible alteration
 Local anesthesia administration
 Placement of sealants
 Removal of plaque, stain, or hard natural or synthetic material
except by toothbrush, floss or rubber cop coronal polish or removal
of calculus
 Dental radiography – unless authorized/permitted
 Procedures that require skill and professional judgment of dentist
Scope of Practice – DA
Expanded Functions
• Board approved training (can include on the job)
• 9 areas:
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Occlusal registrations
Placement and removal of gingival retraction
Taking of final impressions
Fabrication and removal of provisional restorations
Applying cavity liners and bases, desensitizing agents and
bonding systems
Placement of periodontal dressings
Testing pulp vitality
Monitoring nitrous oxide
Scope of Practice – DA
Expanded Functions (cont.)
• Proposed rules – comment period ended 4/21/15
• Specified education requirements
• 3 Levels:
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Basic
Certified Level 1
Certified Level 2
• Different procedures allowed at each level
Supervision Generally
• Type of personnel
• Type of duty
• Patient need (new vs. recall)
Levels of Supervision
• Personal = dentist physically present in treatment
room
• Direct = dentist present in facility, but not necessarily
in room
• General = services delegated by dentist to DA or
RDH
• Public Health = dentist delegates duties in public
health setting without need for initial exam by dentist
Supervision of RDH
• Direct:
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
admin of local anesthesia or nitrous oxide
new patients (except public health supervision)
• General:
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all authorized services if dentist has examined first
educational, assessment, screening or data collection to
prepare prelim report can be done without seeing dentist first
• Subsequent exams and monitoring is responsibility
of dentist; carried out in “reasonable period of time in
accordance with professional judgment”
Supervision of RDH (cont.)
• General supervision – if dentist not present in
facility, additional requirements:
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Inform patient or legal guardian prior to appointment
RDH must consent
Basic emergency procedures established and RDH capable
of implementing
Treatment provided prescribed by dentist and entered in
writing in patient record
Supervision of RDA
• Direct: all actions not allowed under general (all
intraoral duties), expanded functions
• General: limited to all extraoral duties, dental
radiography, intraoral suctioning
• Dentist must see patient first (only way to properly
delegate for general supervision)
• Proposed rule – adds “use of curing light and
intraoral camera”
• Personal supervision if person is trainee
Public Health Supervision
• Currently limited to RDH
• Proposed Rules to expand to DA
Public Health Supervision
(cont.)
• Definition of public health settings
• Dentist authorizes and delegates, but
dental exam not required in advance
• Dentist not required to provide future
dental treatment to patients served
Public Health Supervision
(cont.)
• Written agreement requirements
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Dentist available for communication and consultation with
RDH
Age and procedure specific standing orders
Time period for when dental exam must occur
Identify locations
• RDH must also
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
Obtain consents from patients indicating that their services
do not replace dental exams
Specify procedure for records
Public Health Supervision
(cont.)
• Dentist and RDH must have copies of
agreement
• Copy also filed with Oral Health Bureau
of DPH
• RDH provides summary report to Board
at least annually
“Check Up” on your Personnel
• Are all licenses and registrations current?
• Are all licenses and registrations on display
in office?
• Are you using the proper level of
supervision?
• Are the services within their scope of
practice?
Types of Sedation
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•
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Deep or General Anesthesia
Moderate
Nitrous Oxide Inhalation Analgesia
Minimal or Anti-Anxiety Premedication
or Anxiolysis
Why there are Rules regarding
Sedation
[insert video – “David After Dentist”]
Deep Sedation or General
Anesthesia
• “controlled state of unconsciousness,
produced by a pharmacological agent,
accompanied by partial or complete
loss of protective reflexes, including
inability to independently maintain an
airway and respond purposefully to
physical stimulation or verbal
command”
Deep Sedation Requirements –
Dentist’s Permit
• Advanced education program accredited by Commission on
Dental Accreditation that provides deep sedation/general
anesthesia training
• Formal training in airway management
• Minimum 1 year of advanced training in anesthesiology and
related academic subjects beyond undergraduate dental school
level, training must be Board-approved
• Completion of peer review evaluation as required by Board
• Current and successful completion of Advanced Cardiac Life
Support Course
Deep Sedation Requirements –
Facility
• Proper Equipment
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Capnography
EKG monitor
Positive pressure oxygen
Suction
Laryngoscope and blades
Endotracheal tubes
Magill forceps
Oral airways
Stethoscope
Blood pressure monitoring device
Pulse oximeter
Emergency drugs
defibrillator
Deep Sedation Requirements –
Personnel
• 2 qualified auxiliary personnel in room
• “Capable of reasonably handling
procedures, problems and emergencies
incident to the administration of general
anesthesia”
• Maintain current certification in basic
life support and be capable of
administering it
Moderate Sedation
• “drug-induced depression of consciousness, either
by enteral or paraenteral means, during which
patients respond purposefully to verbal commands,
either alone or accompanied by light tactile
stimulation. No interventions are required to
maintain patient airway and spontaneous ventilation
is adequate. Cardiovascular function is usually
maintained.”
• f/k/a “conscious sedation”
Moderate Sedation
Requirements – Dentist’s Permit
•
•
•
•
•
•
Completion of Board-approved training program that meets ADA Guidelines for
Teaching Pain Control and Sedation to Dentists and Dental Students –
minimum 60 hours of instruction and management for at least 20 patients
Formal training in airway management
Peer review evaluation
Current and successful completion of Advanced Cardiac Life Support course
(or PALS if administering to pediatric patients)
Alternative option: Completion of accredited residency program that includes
formal training and clinical experience in moderate sedation; program is Boardapproved
If pediatric or ASA category 3 or 4 patients – must have formal training in
anesthesia and clinical experience in managing pediatric or ASA category 3 or
4 patients.
Moderate Sedation
Requirements – Facility
• Proper Equipment
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Capnography or pretracheal/precordial stethoscope*
EKG monitor
Positive pressure oxygen
Suction
Laryngoscope and blades
Endotracheal tubes
Magill forceps
Oral airways
Stethoscope
Blood pressure monitoring device
Pulse oximeter
Emergency drugs
Defibrillator
Moderate Sedation
Requirements – Personnel
• 1 qualified auxiliary personnel in room
• “capable of reasonably handling procedures,
problems and emergencies incident to the
administration of general anesthesia”
• Maintain current certification in basic life
support and be capable of administering it
Deep and Moderate Sedation –
Additional Issues
• Permits are biennial; renew same time as
license
• Facility inspections every 5 years
• Capnography use required effective 1/1/2014
for deep sedation
• Capnography or pretracheal/precordian
stethoscope use required effective 1/1/2015
for moderate sedation
Nitrous Oxide - Requirements
• Completion of Board-approved training or equivalent
training while in accredited dental school
• Adequate equipment with fail-safe features and
minimum oxygen flow that meets FDA standards
• Routine inspection, calibration and maintenance on
equipment every 2 years; maintain documentation
• Continuous monitoring of patient by qualified
personnel
• Trained and capable of administering basic life
support
Nitrous Oxide – Administration
by RDH
• Delegated by Dentist
• RDH has Board-approved training or
received equivalent while in accredited
dental hygiene school
Nitrous Oxide – Monitoring by
RDH or RDA
• Delegated by Dentist and performed under direct
supervision
• Must have written protocols for taking vitals,
adjusting anesthetic concentrations and addressing
emergency situations
• RDH or RDA has Board-approved training or
received equivalent while in accredited dental
hygiene school or dental assistant school
• Adverse reactions reported to Dentist immediately
• Dentist dismisses patient at end of procedure
Minimal Sedation
• “minimally depressed level of consciousness,
produced by a pharmacological method, that retains
the patient’s ability to independently and
continuously maintain an airway and respond
normally to tactile stimulation and verbal command.
Although cognitive function and coordination may be
modestly impaired, ventilatory and cardiovascular
functions are unaffected”
• a/k/a Anti-anxiety premedication or anxiolysis
Minimal Sedation Requirements
• Dentist trained and capable of administering basic life support
• Adults:
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Prescribe or administer single enteral drug that is no more than 1.0
times the MRD for unmonitored home use
Single supplemental dose of SAME drug may be administered if
supplemental dose is no more than ½ of the initial dose and it is
not administered until the clinical half-life of initial dose has passed
Total aggregate dose cannot exceed 1.5 times MRD on day of
treatment
Many use nitrous in combo with single enteral drug
Combining 2 or more enteral drugs (not including nitrous) or
prescribing/administering drugs not recommended for unmonitored
home use = moderate sedation
Minimal Sedation Requirements
(cont.)
• Pediatric or ASA category 3 or 4
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Prescribe or administer single enteral drug that is
no more than 1.0 times the MRD for unmonitored
home use
May administer nitrous oxide for minimal sedation
so long as concentration does not exceed 50%
and is NOT used in combo with any other drug
Combining one or more enteral drugs with nitrous
oxide or use of more than a single enteral drug or
administering IV drug = moderate sedation
Minimal Sedation – Additional
Issues
• Cannot bill for non-IV conscious or
moderate sedation
• Advertising must clearly reflect that it is
minimal sedation
“Check Up” on Your Sedation
Practices
• What level of sedation are you intending to
achieve?
• Do you have the proper training and permits?
• Do you have properly trained personnel?
• Do you have proper equipment in facility?
Advertising - Content
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Accurate
Not false, untrue, deceptive or misleading
Do not misrepresent credentials, training, experience or ability
Do not appeal to person’s anxiety in excessive or unfair way
Do not create unjustified expectations of results
Realistic assessment of safety and efficacy of products or
procedures
• Do not make material claims of superiority that cannot be
unsubstantiated
Advertising – Raising the Red
Flag
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Claims that the professional, the service or the materials are superior when the
superiority cannot be substantiated
Use of unearned or nonhealth degree
Use of attainment of honorary fellowship (i.e.: not based upon merit, study or
research)
Promotion of service that is beyond dentist’s ability
Communication that intimidates, exerts undue pressure or undue influence
Use of personal testimony re: quality of competence when it’s not reasonably
verifiable
Use of statistical data re: past performance/prediction of future success
Use of personally identifiable facts/data/info about patient without patient consent
Misrepresentation of material fact
Suppression, omission or concealment of material fact
Communication that creates unjustified expectation of result
“Bait and switch”
Advertising Example
[insert video “Best Dentist Commercial Ever!”]
Additional “Check Up” Areas
• Are you satisfying all record keeping
requirements? (650-27.11)
• Are you appropriately prescribing,
administering and dispensing drugs?
(650-16)
QUESTIONS
Website: www.brownwinick.com
Toll Free Phone Number: 1-888-282-3515
OFFICE LOCATIONS:
666 Grand Avenue, Suite 2000
Des Moines, Iowa 50309-2510
Telephone: (515) 242-2400
Facsimile: (515) 283-0231
616 Franklin Place
Pella, Iowa 50219
Telephone: (641) 628-4513
Facsimile: (641) 628-8494
DISCLAIMER: No oral or written statement made by BrownWinick attorneys should
be interpreted by the recipient as suggesting a need to obtain legal counsel from
BrownWinick or any other firm, nor as suggesting a need to take legal action. Do not
attempt to solve individual problems upon the basis of general information provided
by any BrownWinick attorney, as slight changes in fact situations may cause a
material change in legal result.