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Chapter 15: Risk Management in Ambulatory Care Settings
Ambulatory Settings
There has been a steady flow of clinical services out of hospital
settings into more cost-effective outpatient settings
Risk management is as important in the outpatient setting as it
is in the inpatient, especially as outpatient settings are not
subject to accreditation
Of all paid malpractice claims, a greater number are coming
from the ambulatory setting than from inpatient alone
Why the increased risk?
Ambulatory settings differ from inpatient in that they do not
have the same mix of specially trained professionals managing
patient care 24 hours a day including detailed documentation,
observation, decision support teams
Ambulatory setting provides infrequent care spread over time
and patients are generally seen by personnel with a lower level
of training performing tasks in multiple areas
Assessment of the Practice Setting
Risk Managers need to assess the risks inherent to the specific
site
Management of risk in the ambulatory setting sites on 3 core
principles:
A culture of safety
Good employment practices
Ethical business practices
Culture of Safety
It is important to recognize that human errors are inevitable and
leads to ways to strengthen the system of care rather than
punishment
4 Key Features
Psychological safety
Active leadership
Transparency
Fairness
Good Employment Practices
Under the principle of vicarious liability, the facility owner is
legally responsible for the actions of their employees
Potential risks:
Non-physician employee exceeding their legally authorized
duties
Inappropriate actions of employees
Fair employment practice issues
Ethical Business Practices
The risk manager must guard the practice against fraud and
abuse by ensuring
Appropriate billing practices
Compliance with Stark Law
No inappropriate upcoding of claims
High Risk Areas
Missed diagnoses
Medication risks
Infectious risks
Communication
Documentation
Office Management
Clear and regularly updated policies and procedures wil l help
maintain high standards of patient care and lower the risk of
lawsuits
The Policy and Procedure Manual should be available to all
employees and follow the mission, vision and values of the
practice setting.
Policy Manual Section –
Administration
Describes the organization of the practice setting
Hours of operation
Holidays
Emergency contact after hours
HIPAA
Patient Rights (including children)
Patient responsibilities
Missed appointment policy
Patient complaint procedure
Transfer of care to another provider
Consent forms (including treatment of minors)
Advance directives
Clarifies HR issues
Hiring - Application process, forms and reference checks
Verification of credentials and identity
Verification of Immunization and TB testing
Compliance with employment laws
Job descriptions
Various employee policies
Employee grievance policy
Workplace violence policy
Disciplinary procedures
Employee training
Dress code
Policy Manual Section –
Personnel
Policy Manual Section –
Records
Describes policies and procedures for patient health records
Mandated logs
Records maintenance
Records storage
Archiving of hardcopy records
Backup of electronic records
Documentation of missed appointments and communication of
all test results
Policy Manual Section –
Infection Control
Describes policies and procedures to allow personnel to provide
safe care and assess infection prevention practices
Hand hygiene
Personnel protective equipment
Injection safety
Respiratory hygiene
Environmental cleaning
Sterilization of equipment
Disinfection of reusable instruments
Policy Manual Section –
Risk Management
Describe routine policies needed to cover
Potential fraud
Lapses in confidentiality
Adverse patient outcomes
Lawsuits
Compliance plan and compliance officer as required by the OIG
Policy Manual Section –
Quality Management
Describes the practice’s policies and procedures for quality
control
Assessment procedures
Improvement plans
Summary
Ambulatory care settings continue to evolve and face many
challenges in patient safety and compliance with laws on
business practice.
Risk management is essential to meet these challenges.
KEISER UNIVERSITY
Pembroke Pines Campus
BUSINESS ADMINISTRATION DEPARTMENT
UPDATED MARCH 8, 2003
CAPSTONE PROJECT
Project Title
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xxxxxxxxxx
By
Student Name
Submitted to the Department Director and Faculty
in partial fulfillment of the requirements
for the degree of
BACHELOR OF ARTS IN BUSINESS ADMINISTRATION
December 5, 2012
CERTIFICATION STATEMENT
I hereby certify that this paper constitutes my own product, that
where the language of others is set forth, quotation marks so
indicate, and that appropriate credit is given where I have used
the language, ideas, expressions or writings of another.
Signed
Student’s Name
ABSTRACT
Project Title
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By
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The abstract must be less than 350 words and should not exceed
more than two pages.
TABLE OF CONTENTS
Page
Section
INTRODUCTION3
Background3
Rationale for Topic Selection3
Purpose of the Study4
Definition of Terms4
REVIEW OF LITEraTURE5
Introduction5
Sub-topic #25
Sub-topic #35
SUMMARY AND CONCLUSIONS7
Introduction7
Summary of the Study7
Conclusions7
REFERENCES CITED9
BIBLIOGRAPHY10
SECTION I
INTRODUCTION
Background
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SECTION II
REVIEW OF LITEraTURE
Introduction
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SECTION III
SUMMARY AND CONCLUSIONS
Introduction
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REFERENCES CITED
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BIBLIOGRAPHY
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Chapter 15: Risk Management in Ambulatory Care Settings
Ambulatory Settings
There has been a steady flow of clinical services out of hospital
settings into more cost-effective outpatient settings
Risk management is as important in the outpatient setting as it
is in the inpatient, especially as outpatient settings are not
subject to accreditation
Of all paid malpractice claims, a greater number are coming
from the ambulatory setting than from inpatient alone
Why the increased risk?
Ambulatory settings differ from inpatient in that they do not
have the same mix of specially trained professionals managing
patient care 24 hours a day including detailed documentation,
observation, decision support teams
Ambulatory setting provides infrequent care spread over time
and patients are generally seen by personnel with a lower level
of training performing tasks in multiple areas
Assessment of the Practice Setting
Risk Managers need to assess the risks inherent to the specific
site
Management of risk in the ambulatory setting sites on 3 core
principles:
A culture of safety
Good employment practices
Ethical business practices
Culture of Safety
It is important to recognize that human errors are inevitable and
leads to ways to strengthen the system of care rather than
punishment
4 Key Features
Psychological safety
Active leadership
Transparency
Fairness
Good Employment Practices
Under the principle of vicarious liability, the facility owner is
legally responsible for the actions of their employees
Potential risks:
Non-physician employee exceeding their legally authorized
duties
Inappropriate actions of employees
Fair employment practice issues
Ethical Business Practices
The risk manager must guard the practice against fraud and
abuse by ensuring
Appropriate billing practices
Compliance with Stark Law
No inappropriate upcoding of claims
High Risk Areas
Missed diagnoses
Medication risks
Infectious risks
Communication
Documentation
Office Management
Clear and regularly updated policies and procedures will help
maintain high standards of patient care and lower the risk of
lawsuits
The Policy and Procedure Manual should be available to all
employees and follow the mission, vision and values of the
practice setting.
Policy Manual Section –
Administration
Describes the organization of the practice setting
Hours of operation
Holidays
Emergency contact after hours
HIPAA
Patient Rights (including children)
Patient responsibilities
Missed appointment policy
Patient complaint procedure
Transfer of care to another provider
Consent forms (including treatment of minors)
Advance directives
Clarifies HR issues
Hiring - Application process, forms and reference checks
Verification of credentials and identity
Verification of Immunization and TB testing
Compliance with employment laws
Job descriptions
Various employee policies
Employee grievance policy
Workplace violence policy
Disciplinary procedures
Employee training
Dress code
Policy Manual Section –
Personnel
Policy Manual Section –
Records
Describes policies and procedures for patient health records
Mandated logs
Records maintenance
Records storage
Archiving of hardcopy records
Backup of electronic records
Documentation of missed appointments and communication of
all test results
Policy Manual Section –
Infection Control
Describes policies and procedures to allow personnel to provide
safe care and assess infection prevention practices
Hand hygiene
Personnel protective equipment
Injection safety
Respiratory hygiene
Environmental cleaning
Sterilization of equipment
Disinfection of reusable instruments
Policy Manual Section –
Risk Management
Describe routine policies needed to cover
Potential fraud
Lapses in confidentiality
Adverse patient outcomes
Lawsuits
Compliance plan and compliance officer as required by the OIG
Policy Manual Section –
Quality Management
Describes the practice’s policies and procedures for quality
control
Assessment procedures
Improvement plans
Summary
Ambulatory care settings continue to evolve and face many
challenges in patient safety and compliance with laws on
business practice.
Risk management is essential to meet these challenges.
Chapter 13
Epidemiologic Aspects of Work and the Environment
Learning Objectives
Define the term environmental epidemiology
Give examples of environmental agents that are associated with
human health effects
Provide examples of study designs used in environmental
epidemiology
State methodologic difficulties with research on environmental
health effects
Environmental Epidemiology
Study of disease and health conditions (occurring in the
population) that are linked to environmental factors
Environmental exposures—outside the control of the exposed
individual
Two Examples of Environmental Catastrophes
Deepwater Horizon oil spill, Gulf of Mexico, April 20 to July
15, 2010
Fukushima nuclear reactor meltdown following earthquake in
Japan, March 11, 2011
Human Exposures to Environmental Hazards
Chemical agents
Electromagnetic radiation
Ionizing radiation
Heavy metals
Air pollution
Temperature increases from global warming and climate change
Health Effects Attributed to Environmental Exposures
Cancer
Infertility
Reproductive impacts
Infectious diseases such as malaria
Occupation-specific adverse outcomes
Study Designs Used
Descriptive study designs
Helpful for setting priorities
Hypothesis formulation
Analytic study designs
Effects of low-level exposures
Exposure-effect relationships
Retrospective cohort designs
Hazardous Agents in the Work Environment
Ionizing radiation
Infectious agents
Toxic substances
Drugs
Carcinogenic agents
Health Effects Associated with Work Environment
Health risks for pregnant workers and the unborn fetus
Various lung diseases
Dermatologic problems
Bladder cancer among dye workers
Leukemia among workers exposed to benzene
2
Study Designs Used in Environmental Epidemiology
Descriptive studies provide information for setting priorities,
identifying hazards, and formulating hypotheses for new
occupational risks.
Etiologic studies can be used to show exposure-effect
relationships.
3
Retrospective Cohort Studies
Various end points are used to study the effects of occupational
exposures.
Morbidity: self-reports of symptoms and results of clinical
examinations
Mortality: comparison of mortality rates of exposed workers
with nonexposed workers in the same industry
4
Collection of Exposure Data
Employment records often are used and may include:
Personal identifiers to permit record linkage
Demographic characteristics
Work history
Information about potential confounding variables, e.g., medical
history, smoking habits
5
The Healthy Worker Effect
Observation that employed populations tend to have a lower
mortality experience than the general population.
The healthy worker effect may reduce the measure of effect for
an exposure that increases morbidity or mortality.
6
Ecologic Study Designs
One use is the study of the health effects of air pollution.
Researchers measure the association between average exposure
to air pollution within census tracts and the average mortality in
those census tracts.
Unable to controI for individual factors, e.g., smoking habits
7
Case-Control Studies
Compared with cross-sectional study designs, case-control
studies can provide more complete exposure data.
However, precise quantitation of exposure and unobserved
confounding may be difficult to achieve.
8
Toxicologic Concepts Related to Environmental Epidemiology
Dose-response
Threshold
Latency
Synergism
9
Dose-Response Curve
Graph that is used to assess the effect of exposure to a chemical
or toxic substance upon an organism.
10
Threshold
The lowest dose at which a particular response may occur
11
Latency
The time period between initial exposure and a measurable
response
Latency can range from seconds (acute toxic agents) to years
(mesothelioma).
The long latency of health events in environmental research
makes the detection of hazards difficult.
12
Synergism
A situation in which the combined effect of several exposures is
greater than the sum of the individual effects.
Example: Study conducted among asbestos insulation workers
demonstrated a synergistic relationship between asbestos and
smoking in causing lung cancer.
13
Types of Agents
Chemical agents
Metallic compounds
Electric and magnetic fields
Ionizing radiation
Allergens and molds
Dusts
Physical and mechanical energy
14
Chemical Agents
Many types used at home and at work
Household cleaning agents
Automotive chemicals
Paints
Pesticides
Bisphenol A (BPA) in plastics
Chemical Agents (cont’d)
Potential effects on human health through acute toxicity, direct
skin irritation, contact dermatitis, or long-term effects such as
cancer
15
Pesticides: Used to Control Pests
Insecticides
Herbicides
Rodenticides
16
Four Classes of Insecticides
Organophosphates
Organocarbamates
Pyrethroids
Organochlorides (organochlorines)
Organochloride Insecticides
DDT
Toxic to wildlife and persistent in the environment
Lindane
Chlordane
Chemical Agents (cont’d)
Asbestos
Strictly speaking, a mineral fiber
Was used commonly for ship building, construction, insulation,
and automobiles
Associated with asbestosis, mesothelioma, and lung cancer
Metallic Compounds
Arsenic
Mercury
Lead
Metallic Compounds (cont’d)
Arsenic
A crystalline metalloid
Exists as inorganic compounds in the environment
Many uses
Used as a preservative for residential lumber outlawed
Potential carcinogen, e.g., bladder cancer
Metallic Compounds (cont’d)
Mercury
Used for the treatment of syphilis, as an agricultural fungicide,
and in dental amalgams
Responsible for Minamata disease, which occurred in the mid-
1950s in Minamata Bay, Japan
A neurological condition linked to the consumption of fish
contaminated with mercury
17
Metallic Compounds (cont’d)
Lead
Once widely used in paint and gasoline
Associated with serious central nervous system effects even at
low levels
Has adverse effects on intelligence, behavior, and development
Between 1988 and 2002, percentage of children with elevated
blood lead levels declined steeply
18
Electric and Magnetic Fields
Sources include power lines, microwave ovens, stoves, clocks,
cellular phones.
Los Angeles and Swedish studies found an association between
residential proximity to power lines and childhood cancer risk.
U.S. and Norwegian studies found an increased risk for male
breast cancer among male electrical workers.
19
Ionizing Radiation
Consists of either particle energy (e.g., highly energetic
protons, neutrons, and α and β particles) or electromagnetic
energy (e.g., γ-rays and X-rays)
Sources of ionizing radiation can be natural or synthetic.
20
Ionizing Radiation (cont’d)
Natural sources--examples are radon and cosmic rays.
Radon is one of the largest sources of human exposure to
ionizing radiation and may be the cause of about 21,000 deaths
from lung cancers in the U.S.
Synthetic sources--examples are medical x-rays and nuclear
generators.
Allergens and Molds
Allergens--substances that provoke an allergic reaction in
susceptible individuals
Allergic reactions range from dermatitis, asthma, and itchy eyes
to anaphylactic shock.
21
Physical and Mechanical Energy
Include agents associated with unintentional injuries
Unintentional injuries are a leading cause of death within the
age group 1-44 years in the U.S.
Also include such factors as noise, vibration, and extremes of
temperature
22
Global Warming
Possible association with extreme heat waves
Climate changes in the eastern U.S.
Deaths associated with heat waves
Monitoring and Surveillance of Occupational Hazards
Hazard surveillance--characterization of known chemical,
physical, and biologic agents in the workplace
Sentinel health event--a case of unnecessary disease,
unnecessary disability, or untimely death whose occurrence is a
warning signal that the quality of preventive or medical care
may need to be improved
23
Environmental Hazards Found in the Work Setting
Biologic hazards--Hospital employees, sewage workers, and
agricultural workers may be exposed to hazardous biologic
agents. For example, HIV may infect hospital workers through
accidental needle sticks.
Mineral and organic dusts--Examples include coal dust (mining
and black lung disease) and rubber dust (COPD).
24
Environmental Hazards Found in the Work Setting (cont’d)
Vapors and fumes are likely to become increasing hazards due
to the growing use of chemical substances.
Vapors--Include organic solvents such as benzene, which may
cause cancer and damage internal organs (particularly the liver)
25
Mineral and Organic Dusts
Silicosis
Pulmonary emphysema
Chronic obstructive disease
Coal workers’ pneumoconiosis
Industrial Chemicals
Exposure in occupational settings is up to 100 times higher than
in the ambient environment.
Vinyl chloride—angiosarcoma of the liver
Pesticides
Noteworthy Community Environmental Health Hazards
Hazardous waste sites
Air pollution
Nuclear facilities
Drinking water
27
Sick Building Syndrome
Dryness of the skin and mucous membranes
Mental fatigue
Headaches
Symptoms diminish when affected person leaves the building.
Hazardous Waste Sites
Notorious sites in the U.S. include: Love Canal, NY; Valley of
the Drums, KY; Times Beach, MO; Stringfellow acid pits, CA;
Casmalia Waste Disposal Facility, CA.
Of great concern is the contamination of water supplies by toxic
wastes.
Some possible adverse effects of hazardous waste exposure
include birth defects, neurologic disease, and cancer.
28
Air Pollution
Constituents of air pollution include sulfur oxides, particles,
ozone, and lead and other heavy metals.
Lethal air pollution episodes have occurred worldwide.
Studies conducted in New York City, St. Louis, and Tennessee
have shown a correlation between increases in daily mortality
and increased air pollution.
29
Environmental Tobacco Smoke (ETS)
Nonsmokers who work in a smoking environment have reduced
pulmonary function compared to nonsmokers in a smoke-free
work environment.
ETS causes 3,000 lung cancer deaths annually among
nonsmokers.
ETS is associated with children’s bronchitis, pneumonia, and
asthma.
30
Nuclear Facilities
Include weapons production plants, test sites, and nuclear power
plants
Studies of living in close proximity to nuclear installations have
shown conflicting results regarding cancer rates.
Following the Chernobyl nuclear power plant accident, thyroid
cancer rates increased near the reactor.
31
Drinking Water
Chemical plants and nuclear facilities may contaminate ground
water.
Chlorination of water supply has helped to decrease the
incidence of gastroenteric diseases.
Lead and asbestos particles may be present in water and have
potential for toxicity.
32
Chapter 13
Epidemiologic Aspects of Work and the Environment
Learning Objectives
Define the term environmental epidemiology
Give examples of environmental agents that are associated with
human health effects
Provide examples of study designs used in environmental
epidemiology
State methodologic difficulties with research on environmental
health effects
Environmental Epidemiology
Study of disease and health conditions (occurring in the
population) that are linked to environmental factors
Environmental exposures—outside the control of the exposed
individual
Two Examples of Environmental Catastrophes
Deepwater Horizon oil spill, Gulf of Mexico, April 20 to July
15, 2010
Fukushima nuclear reactor meltdown following earthquake in
Japan, March 11, 2011
Human Exposures to Environmental Hazards
Chemical agents
Electromagnetic radiation
Ionizing radiation
Heavy metals
Air pollution
Temperature increases from global warming and climate change
Health Effects Attributed to Environmental Exposures
Cancer
Infertility
Reproductive impacts
Infectious diseases such as malaria
Occupation-specific adverse outcomes
Study Designs Used
Descriptive study designs
Helpful for setting priorities
Hypothesis formulation
Analytic study designs
Effects of low-level exposures
Exposure-effect relationships
Retrospective cohort designs
Hazardous Agents in the Work Environment
Ionizing radiation
Infectious agents
Toxic substances
Drugs
Carcinogenic agents
Health Effects Associated with Work Environment
Health risks for pregnant workers and the unborn fetus
Various lung diseases
Dermatologic problems
Bladder cancer among dye workers
Leukemia among workers exposed to benzene
2
Study Designs Used in Environmental Epidemiology
Descriptive studies provide information for setting priorities,
identifying hazards, and formulating hypotheses for new
occupational risks.
Etiologic studies can be used to show exposure-effect
relationships.
3
Retrospective Cohort Studies
Various end points are used to study the effects of occupational
exposures.
Morbidity: self-reports of symptoms and results of clinical
examinations
Mortality: comparison of mortality rates of exposed workers
with nonexposed workers in the same industry
4
Collection of Exposure Data
Employment records often are used and may include:
Personal identifiers to permit record linkage
Demographic characteristics
Work history
Information about potential confounding variables, e.g., medical
history, smoking habits
5
The Healthy Worker Effect
Observation that employed populations tend to have a lower
mortality experience than the general population.
The healthy worker effect may reduce the measure of effect for
an exposure that increases morbidity or mortality.
6
Ecologic Study Designs
One use is the study of the health effects of air pollution.
Researchers measure the association between average exposure
to air pollution within census tracts and the average mortality in
those census tracts.
Unable to controI for individual factors, e.g., smoking habits
7
Case-Control Studies
Compared with cross-sectional study designs, case-control
studies can provide more complete exposure data.
However, precise quantitation of exposure and unobserved
confounding may be difficult to achieve.
8
Toxicologic Concepts Related to Environmental Epidemiology
Dose-response
Threshold
Latency
Synergism
9
Dose-Response Curve
Graph that is used to assess the effect of exposure to a chemical
or toxic substance upon an organism.
10
Threshold
The lowest dose at which a particular response may occur
11
Latency
The time period between initial exposure and a measurable
response
Latency can range from seconds (acute toxic agents) to years
(mesothelioma).
The long latency of health events in environmental research
makes the detection of hazards difficult.
12
Synergism
A situation in which the combined effect of several exposures is
greater than the sum of the individual effects.
Example: Study conducted among asbestos insulation workers
demonstrated a synergistic relationship between asbestos and
smoking in causing lung cancer.
13
Types of Agents
Chemical agents
Metallic compounds
Electric and magnetic fields
Ionizing radiation
Allergens and molds
Dusts
Physical and mechanical energy
14
Chemical Agents
Many types used at home and at work
Household cleaning agents
Automotive chemicals
Paints
Pesticides
Bisphenol A (BPA) in plastics
Chemical Agents (cont’d)
Potential effects on human health through acute toxicity, direct
skin irritation, contact dermatitis, or long-term effects such as
cancer
15
Pesticides: Used to Control Pests
Insecticides
Herbicides
Rodenticides
16
Four Classes of Insecticides
Organophosphates
Organocarbamates
Pyrethroids
Organochlorides (organochlorines)
Organochloride Insecticides
DDT
Toxic to wildlife and persistent in the environment
Lindane
Chlordane
Chemical Agents (cont’d)
Asbestos
Strictly speaking, a mineral fiber
Was used commonly for ship building, construction, insulation,
and automobiles
Associated with asbestosis, mesothelioma, and lung cancer
Metallic Compounds
Arsenic
Mercury
Lead
Metallic Compounds (cont’d)
Arsenic
A crystalline metalloid
Exists as inorganic compounds in the environment
Many uses
Used as a preservative for residential lumber outlawed
Potential carcinogen, e.g., bladder cancer
Metallic Compounds (cont’d)
Mercury
Used for the treatment of syphilis, as an agricultural fungicide,
and in dental amalgams
Responsible for Minamata disease, which occurred in the mid-
1950s in Minamata Bay, Japan
A neurological condition linked to the consumption of fish
contaminated with mercury
17
Metallic Compounds (cont’d)
Lead
Once widely used in paint and gasoline
Associated with serious central nervous system effects even at
low levels
Has adverse effects on intelligence, behavior, and development
Between 1988 and 2002, percentage of children with elevated
blood lead levels declined steeply
18
Electric and Magnetic Fields
Sources include power lines, microwave ovens, stoves, clocks,
cellular phones.
Los Angeles and Swedish studies found an association between
residential proximity to power lines and childhood cancer risk.
U.S. and Norwegian studies found an increased risk for mal e
breast cancer among male electrical workers.
19
Ionizing Radiation
Consists of either particle energy (e.g., highly energetic
protons, neutrons, and α and β particles) or electromagnetic
energy (e.g., γ-rays and X-rays)
Sources of ionizing radiation can be natural or synthetic.
20
Ionizing Radiation (cont’d)
Natural sources--examples are radon and cosmic rays.
Radon is one of the largest sources of human exposure to
ionizing radiation and may be the cause of about 21,000 deaths
from lung cancers in the U.S.
Synthetic sources--examples are medical x-rays and nuclear
generators.
Allergens and Molds
Allergens--substances that provoke an allergic reaction in
susceptible individuals
Allergic reactions range from dermatitis, asthma, and itchy eyes
to anaphylactic shock.
21
Physical and Mechanical Energy
Include agents associated with unintentional injuries
Unintentional injuries are a leading cause of death within the
age group 1-44 years in the U.S.
Also include such factors as noise, vibration, and extremes of
temperature
22
Global Warming
Possible association with extreme heat waves
Climate changes in the eastern U.S.
Deaths associated with heat waves
Monitoring and Surveillance of Occupational Hazards
Hazard surveillance--characterization of known chemical,
physical, and biologic agents in the workplace
Sentinel health event--a case of unnecessary disease,
unnecessary disability, or untimely death whose occurrence is a
warning signal that the quality of preventive or medical care
may need to be improved
23
Environmental Hazards Found in the Work Setting
Biologic hazards--Hospital employees, sewage workers, and
agricultural workers may be exposed to hazardous biologic
agents. For example, HIV may infect hospital workers through
accidental needle sticks.
Mineral and organic dusts--Examples include coal dust (mining
and black lung disease) and rubber dust (COPD).
24
Environmental Hazards Found in the Work Setting (cont’d)
Vapors and fumes are likely to become increasing hazards due
to the growing use of chemical substances.
Vapors--Include organic solvents such as benzene, which may
cause cancer and damage internal organs (particularly the liver)
25
Mineral and Organic Dusts
Silicosis
Pulmonary emphysema
Chronic obstructive disease
Coal workers’ pneumoconiosis
Industrial Chemicals
Exposure in occupational settings is up to 100 times higher than
in the ambient environment.
Vinyl chloride—angiosarcoma of the liver
Pesticides
Noteworthy Community Environmental Health Hazards
Hazardous waste sites
Air pollution
Nuclear facilities
Drinking water
27
Sick Building Syndrome
Dryness of the skin and mucous membranes
Mental fatigue
Headaches
Symptoms diminish when affected person leaves the building.
Hazardous Waste Sites
Notorious sites in the U.S. include: Love Canal, NY; Valley of
the Drums, KY; Times Beach, MO; Stringfellow acid pits, CA;
Casmalia Waste Disposal Facility, CA.
Of great concern is the contamination of water supplies by toxic
wastes.
Some possible adverse effects of hazardous waste exposure
include birth defects, neurologic disease, and cancer.
28
Air Pollution
Constituents of air pollution include sulfur oxides, particles,
ozone, and lead and other heavy metals.
Lethal air pollution episodes have occurred worldwide.
Studies conducted in New York City, St. Louis, and Tennessee
have shown a correlation between increases in daily mortality
and increased air pollution.
29
Environmental Tobacco Smoke (ETS)
Nonsmokers who work in a smoking environment have reduced
pulmonary function compared to nonsmokers in a smoke-free
work environment.
ETS causes 3,000 lung cancer deaths annually among
nonsmokers.
ETS is associated with children’s bronchitis, pneumonia, and
asthma.
30
Nuclear Facilities
Include weapons production plants, test sites, and nuclear power
plants
Studies of living in close proximity to nuclear installations have
shown conflicting results regarding cancer rates.
Following the Chernobyl nuclear power plant accident, thyroid
cancer rates increased near the reactor.
31
Drinking Water
Chemical plants and nuclear facilities may contaminate ground
water.
Chlorination of water supply has helped to decrease the
incidence of gastroenteric diseases.
Lead and asbestos particles may be present in water and have
potential for toxicity.
32
Chapter 14
Molecular and Genetic Epidemiology
Learning Objectives
Differentiate between molecular and genetic epidemiology
Describe principles of inheritance and sources of genetic
variation
Define epidemiologic approaches for the identification of
genetic components to disease
Peeking into the “Black Box”
Many risk factors can be quantified through questionnaires,
records, and easily measured attributes (such as blood pressure
and anthropometrics).
The biological mechanism(s) through which these factors
influence disease is not always apparent (i.e., a “black box”).
Value of Mechanistic Insight
Biologic plausibility is a criterion for causality.
Linking lifestyle risk factors with measures of biologic effect
strengthens interpretations of causality.
This linkage, in turn, provides stronger support for
interventions.
Why Distinguish Between Molecular and Genetic
Epidemiology?
The basic tenets and principles of molecular and genetic
epidemiology are the same.
However, there are specific features regarding design, analysis
and interpretation inherent in the latter.
3
Definition of Genetic Epidemiology
A discipline that seeks to unravel the role of genetic factors and
their interactions with environmental factors in the etiology of
diseases, using family and population study approaches.
4
Key Aspects of This Definition
Inherited susceptibility does not mean inherited disease--
environment matters!
When families are studied, the observations (study subjects) are
no longer independent.
This dependence requires special considerations for the analysis
of data.
5
Genetic Epidemiology is a Method to Answer:
Does a disease cluster in families?
If so, is that clustering likely a result of shared non-genetic risk
factors?
If the clustering is not accounted for by shared lifestyle or
common environment, is the pattern of disease consistent with
inherited effects?
If so, where is the putative gene?
6
What Diseases or Risk Factors Cluster in Families?
Heart disease
Various cancers
Alcoholism
Others
Epidemiologic Assessment of Clustering
Case-control study
Comparison of the frequency of a positive family history
Expectation under genetic influence
Clustering of “Non-Genetic” Exposures in Families
Employment (e.g., several family members with medical
degrees)
Radon from soil
Religious preferences
Lead in paint
Others?
7
Major Point of This Section
You cannot tell easily whether clustering of a risk factor or
disease within a family is due to genetics, culture, or shared
environment (including social or political factors).
Clustering within a family will also occur simply due to bad
luck!
8
Other Correlates of Family History
Large family size
Age of relatives (for an age-related disease)
Gender distribution (consider testicular cancer, prostate disease,
ovarian cysts)
Analysis Approach
Model Y (case/control status) = established risk factors.
Add family history variable to denote “genetic” influence (i.e.,
share genes with an individual who has the outcome of interest).
Analysis Issues
Try to compare (and control if necessary) differences between
cases and controls with regard to size of family.
Not easy to adjust for age of family members or their risk
factors.
What types of data can you ask your cases and controls to
provide about their relatives?
Motivation for Case-Control Family Studies
To rule out influence of shared environment, family size
differences, and age on differences in the frequency of family
history between cases and controls
Need to enumerate the relatives of cases and controls, and
determine the disease status and risk factor profile for each
relative
Conduct of Family Studies
Ascertain “probands” (index cases).
Define family (siblings? children? parents? grandparents?)
Invite family members to participate
Collect data (and, typically, biological samples)
How to Select Control Families
Must decide how to identify controls
From spouse’s side of proband’s family?
Or select a random sample from the population?
Will controls be motivated to participate?
Must take HIPAA rules into account
Analysis Issues
Exclude the index cases and controls
Model disease (or behavior) of interest based on age, sex,
known risk factors
Evaluate evidence for genetic effect through statistical
significance of variable(s) that indicate “relationship to index
case”
Analysis Issues (cont’d)
Simplest “genetic” variable (1 if relative of case, 0 if relative of
control)
Can also construct indicator variables to designate type of
relative (parent, sibling, more distant relative)
If not significant after including other risk factors, then no
evidence for genetic influence
Evidence of Genetic Influence, so far….
Cases are more likely to have a family history of disease than
controls.
The excess risk to relatives is not accounted for by age, sex, and
other risk factors.
What does that tell us about the underlying genetic influence?
(nothing)
Other Approaches to Identify Genetic Influences
Twin studies
Segregation analysis
Linkage analysis
Twin Studies
A “natural experiment” of sorts
Monozygotic (MZ) twins are genetically identical.
Dizygotic (DZ) twins share, on average, the same proportion of
genes as siblings.
Greater concordance (for dichotomous traits) or correlation (for
continuous traits) for MZ than DZ twins is evidence of a genetic
influence.
9
Linkage Analysis
One way to distinguish cultural inheritance from genetic
inheritance is to track a region of our DNA that is transmitted
from parents to offspring in the same manner as the
disease/outcome of interest.
This procedure works well for diseases that follow simple rules
of inheritance (e.g., autosomal dominant or recessive).
10
Segregation Analysis
Historically, linkage analysis required knowledge of the mode
of transmission of the putative gene [dominant versus recessive,
allele frequency, lifetime or age-specific risk (penetrance)].
Segregation analysis has been used to estimate these
parameters.
Genetic Epidemiology of Complex Diseases
“Complex diseases” are ones for which the genetic influence
may be modest and environmental factors contribute to disease
risk.
Segregation analysis is not typically done for “complex
diseases.”
Modern approaches ignore models of inheritance (non-
parametric methods).
Use of Epidemiology to Understand Genetic Variation
The methods of genetic epidemiology have been applied
historically to identify genes.
Typically, epidemiologists are not interested in mapping genes,
but rather in figuring out how genes interact with environment
to influence disease risk and outcome.
Molecular Epidemiology
Related individuals are not necessarily required for studies of
the association of genetic variation with risk of disease.
Both cohort and case-control designs can be used.
Because genetic code (germline DNA) is unchanged since
conception, one readily can employ retrospective designs.
Common Strategies for Genetic Marker Selection
Genome-wide approach with anonymous DNA markers
(1,000,000 SNPs on a chip)
SNPs or simple tandem repeat markers in “candidate” genes
based on a priori knowledge about presumed function
SNPs in candidate genes with known functional effect on level
or activity of protein product
Primer on Single Nucleotide Polymorphis ms (SNPs)
Because of our redundant genetic code, some SNPs will not
alter the encoded amino acid (e.g., GGA, GGG, GGT and GGC
all encode proline).
SNPs that change an amino acid may not necessarily lead to
change in function of transcribed protein.
More on SNPs
SNPs that don’t change an amino acid may still lead to alternate
splicing of the transcript (and therefore be functionally
important).
SNPs in promoter region may influence level of protein
product–not activity (and therefore be biologically significant).
SNPs in non-coding regions may still have functional effect.
Caveats About SNP Studies
If you’re interested in gene x environment interactions–best to
focus on SNPs with known functional effect.
Human biology is complex: are alterations in one component of
a pathway compensated for by another?
Most SNPs are likely to be modest risk factors–requiring large
sample sizes to determine statistically significant association.
Realistic Expectations
Almost every gene is modified after translation into protein
(e.g., glycosylation, acetylation, methylation).
Thus, the correlation between DNA sequence and protein is far
from perfect.
Most GWAS “hits” are in “gene deserts.”
May be necessary to examine multiple SNPs within a gene and
several genes within a pathway.
Molecular Epidemiology – Beyond Genetics
Biomarkers of exposure and disease extend beyond DNA.
Viral or bacterial load
Morphometric analysis of tissues/cells
Hormone or lipid levels in blood or urine
Other examples?
Conclusion
Molecular and genetic epidemiology represent specialty areas of
expertise.
These specialty areas utilize and apply advances in molecular
biology and molecular genetics of disease to:
Unravel disease etiology.
Enable novel approaches for early detection.
Inform more effective interventions by targeting those at
greatest risk.
Chapter 14
Molecular and Genetic Epidemiology
Learning Objectives
Differentiate between molecular and genetic epidemiology
Describe principles of inheritance and sources of genetic
variation
Define epidemiologic approaches for the identification of
genetic components to disease
Peeking into the “Black Box”
Many risk factors can be quantified through questionnaires,
records, and easily measured attributes (such as blood pressure
and anthropometrics).
The biological mechanism(s) through which these factors
influence disease is not always apparent (i.e., a “black box”).
Value of Mechanistic Insight
Biologic plausibility is a criterion for causality.
Linking lifestyle risk factors with measures of biologic effect
strengthens interpretations of causality.
This linkage, in turn, provides stronger support for
interventions.
Why Distinguish Between Molecular and Genetic
Epidemiology?
The basic tenets and principles of molecular and genetic
epidemiology are the same.
However, there are specific features regarding design, analysis
and interpretation inherent in the latter.
3
Definition of Genetic Epidemiology
A discipline that seeks to unravel the role of genetic factors and
their interactions with environmental factors in the etiology of
diseases, using family and population study approaches.
4
Key Aspects of This Definition
Inherited susceptibility does not mean inherited disease--
environment matters!
When families are studied, the observations (study subjects) are
no longer independent.
This dependence requires special considerations for the analysis
of data.
5
Genetic Epidemiology is a Method to Answer:
Does a disease cluster in families?
If so, is that clustering likely a result of shared non-genetic risk
factors?
If the clustering is not accounted for by shared lifestyle or
common environment, is the pattern of disease consistent with
inherited effects?
If so, where is the putative gene?
6
What Diseases or Risk Factors Cluster in Families?
Heart disease
Various cancers
Alcoholism
Others
Epidemiologic Assessment of Clustering
Case-control study
Comparison of the frequency of a positive family history
Expectation under genetic influence
Clustering of “Non-Genetic” Exposures in Families
Employment (e.g., several family members with medical
degrees)
Radon from soil
Religious preferences
Lead in paint
Others?
7
Major Point of This Section
You cannot tell easily whether clustering of a risk factor or
disease within a family is due to genetics, culture, or shared
environment (including social or political factors).
Clustering within a family will also occur simply due to bad
luck!
8
Other Correlates of Family History
Large family size
Age of relatives (for an age-related disease)
Gender distribution (consider testicular cancer, prostate disease,
ovarian cysts)
Analysis Approach
Model Y (case/control status) = established risk factors.
Add family history variable to denote “genetic” influence (i.e.,
share genes with an individual who has the outcome of interest).
Analysis Issues
Try to compare (and control if necessary) differences between
cases and controls with regard to size of family.
Not easy to adjust for age of family members or their risk
factors.
What types of data can you ask your cases and controls to
provide about their relatives?
Motivation for Case-Control Family Studies
To rule out influence of shared environment, family size
differences, and age on differences in the frequency of family
history between cases and controls
Need to enumerate the relatives of cases and controls, and
determine the disease status and risk factor profile for each
relative
Conduct of Family Studies
Ascertain “probands” (index cases).
Define family (siblings? children? parents? grandparents?)
Invite family members to participate
Collect data (and, typically, biological samples)
How to Select Control Families
Must decide how to identify controls
From spouse’s side of proband’s family?
Or select a random sample from the population?
Will controls be motivated to participate?
Must take HIPAA rules into account
Analysis Issues
Exclude the index cases and controls
Model disease (or behavior) of interest based on age, sex,
known risk factors
Evaluate evidence for genetic effect through statistical
significance of variable(s) that indicate “relationship to index
case”
Analysis Issues (cont’d)
Simplest “genetic” variable (1 if relative of case, 0 if relative of
control)
Can also construct indicator variables to designate type of
relative (parent, sibling, more distant relative)
If not significant after including other risk factors, then no
evidence for genetic influence
Evidence of Genetic Influence, so far….
Cases are more likely to have a family history of disease than
controls.
The excess risk to relatives is not accounted for by age, sex, and
other risk factors.
What does that tell us about the underlying genetic influence?
(nothing)
Other Approaches to Identify Genetic Influences
Twin studies
Segregation analysis
Linkage analysis
Twin Studies
A “natural experiment” of sorts
Monozygotic (MZ) twins are genetically identical.
Dizygotic (DZ) twins share, on average, the same proportion of
genes as siblings.
Greater concordance (for dichotomous traits) or correlation (for
continuous traits) for MZ than DZ twins is evidence of a genetic
influence.
9
Linkage Analysis
One way to distinguish cultural inheritance from genetic
inheritance is to track a region of our DNA that is transmitted
from parents to offspring in the same manner as the
disease/outcome of interest.
This procedure works well for diseases that follow simple rules
of inheritance (e.g., autosomal dominant or recessive).
10
Segregation Analysis
Historically, linkage analysis required knowledge of the mode
of transmission of the putative gene [dominant versus recessive,
allele frequency, lifetime or age-specific risk (penetrance)].
Segregation analysis has been used to estimate these
parameters.
Genetic Epidemiology of Complex Diseases
“Complex diseases” are ones for which the genetic influence
may be modest and environmental factors contribute to disease
risk.
Segregation analysis is not typically done for “complex
diseases.”
Modern approaches ignore models of inheritance (non-
parametric methods).
Use of Epidemiology to Understand Genetic Variation
The methods of genetic epidemiology have been applied
historically to identify genes.
Typically, epidemiologists are not interested in mapping genes,
but rather in figuring out how genes interact with environment
to influence disease risk and outcome.
Molecular Epidemiology
Related individuals are not necessarily required for studies of
the association of genetic variation with risk of disease.
Both cohort and case-control designs can be used.
Because genetic code (germline DNA) is unchanged since
conception, one readily can employ retrospective designs.
Common Strategies for Genetic Marker Selection
Genome-wide approach with anonymous DNA markers
(1,000,000 SNPs on a chip)
SNPs or simple tandem repeat markers in “candidate” genes
based on a priori knowledge about presumed function
SNPs in candidate genes with known functional effect on level
or activity of protein product
Primer on Single Nucleotide Polymorphisms (SNPs)
Because of our redundant genetic code, some SNPs will not
alter the encoded amino acid (e.g., GGA, GGG, GGT and GGC
all encode proline).
SNPs that change an amino acid may not necessarily lead to
change in function of transcribed protein.
More on SNPs
SNPs that don’t change an amino acid may still lead to alternate
splicing of the transcript (and therefore be functionally
important).
SNPs in promoter region may influence level of protein
product–not activity (and therefore be biologically significant).
SNPs in non-coding regions may still have functional effect.
Caveats About SNP Studies
If you’re interested in gene x environment interactions–best to
focus on SNPs with known functional effect.
Human biology is complex: are alterations in one component of
a pathway compensated for by another?
Most SNPs are likely to be modest risk factors–requiring large
sample sizes to determine statistically significant association.
Realistic Expectations
Almost every gene is modified after translation into protein
(e.g., glycosylation, acetylation, methylation).
Thus, the correlation between DNA sequence and protein is far
from perfect.
Most GWAS “hits” are in “gene deserts.”
May be necessary to examine multiple SNPs within a gene and
several genes within a pathway.
Molecular Epidemiology – Beyond Genetics
Biomarkers of exposure and disease extend beyond DNA.
Viral or bacterial load
Morphometric analysis of tissues/cells
Hormone or lipid levels in blood or urine
Other examples?
Conclusion
Molecular and genetic epidemiology represent specialty areas of
expertise.
These specialty areas utilize and apply advances in molecular
biology and molecular genetics of disease to:
Unravel disease etiology.
Enable novel approaches for early detection.
Inform more effective interventions by targeting those at
greatest risk.
Chapter 14: Telemedicine
Telemedicine
The collection and communication of healthcare information
over a distance via telecommunication and/or information
systems from one site to another.
Telemedicine is not the same as the following terms and should
not be used interchangeably:
telehealth
m-health
e-health
Telemedicine Services
Patient Consultation
Specialist Referral Service
Remote Patient Monitoring
Consumer Medical and Health Information and Social Media
Telenursing
Telepharmacy
Telerehabilitation
Emergency Telemedicine
Risk Management and Telemedicine
Many risks remain the same whether the patient is in the same
room as the provider or at a distance
Adding to the risks are
Lack of study data on telemedicine
Variability of state regulations
Lack of significant case law
Lack of significant claims studies
Clinical Care Risks
Risks inherent to clinical specialty remain the same when
utilizing telemedicine with the addition of
Patient non-compliance without the knowledge of the provider
Patient misinterpretation or inability to relate his condition to
the provider
Inability of patient to recall or understand directions
Clinician misinterpretation of the data
Medication errors
Administrative Risks
Administration must evaluate the effectiveness and safety of
telemedicine.
Is it adding to or detracting from the quality of care?
Is it increasing or decreasing morbidity and mortality?
Examples of Administrative Risks
Lack of appropriate operational policies
Lack of quality improvement, patient safety and risk
management programs
Inconsistent or incomplete understanding of the patient-provider
relationship
Integration of the telemedicine into the workflow
Appropriate communication and chain of command
Appropriate documentation
Adverse event notification
Technological Risks
Equipment and function do not meet the need
If equipment and function meet the need, performance does not
Derived data are or become corrupt or unlawfully shared
Consumer Medical and Health Information Services
and Social Media Risks
Use of social media has increased the risk to health facilities:
Lack of case law for guidance
Potential HIPAA violations
Healthcare facility should develop a consumer health education
and social media plan
Summary
Telemedicine is an expanding service with increased risk for the
healthcare organization
As there are few evidence-based studies regarding effectiveness
and no case law, risk managers must be vigilant and monitor
their telemedicine services for potential risk to the organiza tion
Chapter 14: Telemedicine
Telemedicine
The collection and communication of healthcare information
over a distance via telecommunication and/or information
systems from one site to another.
Telemedicine is not the same as the following terms and should
not be used interchangeably:
telehealth
m-health
e-health
Telemedicine Services
Patient Consultation
Specialist Referral Service
Remote Patient Monitoring
Consumer Medical and Health Information and Social Media
Telenursing
Telepharmacy
Telerehabilitation
Emergency Telemedicine
Risk Management and Telemedicine
Many risks remain the same whether the patient is in the same
room as the provider or at a distance
Adding to the risks are
Lack of study data on telemedicine
Variability of state regulations
Lack of significant case law
Lack of significant claims studies
Clinical Care Risks
Risks inherent to clinical specialty remain the same when
utilizing telemedicine with the addition of
Patient non-compliance without the knowledge of the provider
Patient misinterpretation or inability to relate his condition to
the provider
Inability of patient to recall or understand directions
Clinician misinterpretation of the data
Medication errors
Administrative Risks
Administration must evaluate the effectiveness and safety of
telemedicine.
Is it adding to or detracting from the quality of care?
Is it increasing or decreasing morbidity and mortality?
Examples of Administrative Risks
Lack of appropriate operational policies
Lack of quality improvement, patient safety and risk
management programs
Inconsistent or incomplete understanding of the patient-provider
relationship
Integration of the telemedicine into the workflow
Appropriate communication and chain of command
Appropriate documentation
Adverse event notification
Technological Risks
Equipment and function do not meet the need
If equipment and function meet the need, performance does not
Derived data are or become corrupt or unlawfully shared
Consumer Medical and Health Information Services
and Social Media Risks
Use of social media has increased the risk to health facilities:
Lack of case law for guidance
Potential HIPAA violations
Healthcare facility should develop a consumer health education
and social media plan
Summary
Telemedicine is an expanding service with increased risk for the
healthcare organization
As there are few evidence-based studies regarding effectiveness
and no case law, risk managers must be vigilant and monitor
their telemedicine services for potential risk to the organization
HSA-6520 Managerial Epidemiology: Week 6
Human Environmental Impact at Work: Epidemiology: Chapters
13 to 14
Objective: To critically reflect your understanding of the
readings and your ability to apply them to your Health care
Setting.
ASSIGNMENT GUIDELINES (10%):
Human Environmental Impact at Work: Epidemiology. For this
assignment, you are encourage to choose any Job Position from
the Health Care area and critically evaluate, state and describe
the more notable exposures and remediation hazards agent that
can affect your choosing position.
The paper will be 3-5 pages long. Each paper must be
typewritten with 12-point font and double-spaced with standard
margins. Follow APA style 7Th edition format when referring to
the selected articles and include a reference page.
EACH PAPER SHOULD INCLUDE THE FOLLOWING:
1. Introduction (25%) Provide a short-lived outline of the
definition of the term environmental epidemiology and give
examples of environmental agents that are associated with
human health effects.
2. Human Environmental Impact at Work (50%):
For this assignment you are heartened to choose any Job
Position from the Health Care area and judgmentally assess,
state and designate the more distinguished exposures and
remediation hazards agent that can distress the job position of
your choosing.
a. Health Effects associated with environmental Hazards.
b. Toxicology Concepts Related to Environmental
Epidemiology.
c. Types of agents and effect on Human Health
3. Conclusion (16%)
Fleetingly summarize your thoughts & deduction to your
appraisal of the articles and Chapter you read. How did these
articles and Chapters impact your thoughts on Environmental
epidemiology and its importance?
Evaluation will be based on how evidently you respond to the
above, in particular:
a) The meticulousness with which you assessment the articles;
b) The profundity, choice, and association of your paper; and,
c) Your conclusions, including a description of the impact of
these articles and Chapters on any Health Care Setting.
HAS-6505 Health Care Risk Management: Assignment Week 6
Case Study: Chapters 14 & 15
Objective: To judgmentally reveal your knowledge of
Telemedicine Services, Risk management Tactics and your
ability to apply them to your Healthcare Organizatio ns. The
investigative exercises will progress students’ understanding
and skill to think censoriously about the public relations
process, and their problem-solving skills. As a result of this
assignment, students will be better able to comprehend, examine
and apply Telemedicine to Health care organizations.
ASSIGNMENT GUIDELINES (10%):
The students will complete A Case study projects that give the
opportunity to create and apply the concepts learned in this and
previous coursework to analyze a real-world scenario. This
scenario will represent through example the practical
importance and implications of various roles and functions of a
Health Care Administrator and Risk Management. The
assignment will be 3-4 pages long reflecting your understanding
and ability to apply the readings to your Healthcare
Organization. Each paper must be typewritten with 12-point
font and double-spaced with standard margins. Follow APA
style 7th edition format when referring to the selected articles
and include a reference page.
EACH PAPER SHOULD INCLUDE THE FOLLOWING:
1. Introduction (25%) Provide a brief synopsis of the meaning
(not a description) of each Chapter read, in your own words.
2. Your Critique (50%)
Case Study:
Telemedicine technology solves healthcare disparity i ssue in
rural Arizona community
Bisbee's Copper Queen Community Hospital implements
successful telemedicine program, drastically reducing cost and
time spent on patient care
Background Founded in 1880, Bisbee is located in the rolling
hills of the Mule Mountains in southeastern Arizona, some 85
miles from Tucson, and within three miles of the border with
Mexico. The region's rich mineral deposits of copper, gold and
silver first attracted miners who hoped to strike it rich. The
town that developed around the mines was named for DeWitt
Bisbee, a San Francisco Judge and investor in the Copper Queen
Mine who, ironically, never set foot in his namesake. Nearly as
old as Bisbee, the Copper Queen Hospital got its start in a mine
tunnel as part of the mining community. Now known as the
Copper Queen Community Hospital (CQCH), it has served the
town for over 125 years. In more recent times, CQCH has
become an acute care critical access hospital for the more than
6,000-plus Bisbee residents and for many of the county's
140,000 residents. The hospital's mission is to maintain and
support access to basic primary healthcare throughout
southeastern Cochise County and to evolve rural health care and
provide patients with the highest quality services.
Challenge Among the primary challenges of CQCH was how to
provide care for patients who needed specialists. For years,
emergency department patients with possible cardiac or stroke
problems had to be transferred to Tucson and Phoenix hospitals
by ambulance, or " in more life- threatening situations " by
helicopter. CQCH patients often discovered after the fact that,
although healthcare was warranted, the expense of emergency
transfer was not. "Cardiology disease is the number one killer
of people in rural areas," said CQCH CEO, James Dickson.
"And in Bisbee, we lacked consistent care to treat it. We lacked
access to a cardiologist and to the ongoing maintenance care
required after initial treatment. We decided we needed a way to
solve the physician misdistribution and disease management
problems that occur in a rural area like Bisbee." In 2009, CQCH
received a grant to begin a telemedicine cardiology program.
Dickson set out to find a system that would essentially bring
specialists into Bisbee and CQCH without requiring that they
physically be on site. This would eliminate the costly transfer
of patients to Tucson and Phoenix. It would also minimize the
trauma involved for family members of those being transported
far distances. Overall, the implementation of a telemedicine
program would shrink the disparity in healthcare experienced by
the people of Bisbee by making specialists vastly more within
reach without the price tag of on site consultations.
Solution
Dickson and CQCH worked with telemedicine solutions
provider, GlobalMed, to build a tele- cardiology system using
GlobalMed's i8500 Series Mobile Video Cart. The wireless,
telemedicine videoconferencing system includes EasyShare
videoconferencing technology that uses the public Internet,
enabling specialists to visit with patients on a virtual basis. It
also includes a large, flat-panel touch screen PC for fast
communications, as well as a high quality camera providing
remote pan, tilt and optical zoom. Currently in the first phase of
its tele-cardiology program, CQCH has connected its system
and those of other, small Cochise County hospitals with the
larger Tucson medical centers. From December 2009 to June
2010, 36 patients in the Emergency Department with suspected
heart problems required cardiology consultation. Using the
Mobile Telemedicine Cart equipped with a digital stethoscope,
healthcare providers in Bisbee were able to provide
cardiologists in Tucson with the ability to see and speak to the
patients in real-time, hear their heart sounds clearly and review
their electro-cardiograms via fax at the same time. These
consultations confirmed that only nine of the 36 patients needed
transport by ambulance or helicopter to another facility. The 27
patients who stayed in Bisbee were discharged from CQCH with
prescriptions and/or heart monitors. The cost savings to patients
and insurers was approximately $540,000 based on a $10,000
transfer cost and an additional $10,000 hospital stay per patient
who instead had their care provided by CQCH and were able to
remain in Bisbee. "The cost savings patients see as a result of
the remote consultations is immense", said Dickson. "The cost
for a helicopter transport is between $10,000 and $12,000.
Additionally, the cost for treatment in a Tucson hospital is
roughly $10,000 more per visit than it is here in Bisbee. So
we're looking at a savings of about $20,000 per patient just by
having the ability to consult with a specialist remotely, utilizing
the telemedicine system, instead of having to be on-site where
the doctor is.
Results Dickson points to one case in particular as a perfect
example of what tele-cardiology means to the town of Bisbee.
An 81-year old man arrived at CQCH with apparent atrial
fibrillation. A Tucson cardiologist saw the patient via video-
conference, listened to his heart sounds and studied his EKG
before determining that there was no need to move him to
Tucson. The patient was admitted to CQCH, treated overnight
and was discharged the next day with a halter monitor. In his
case, the patient was spared an unnecessary transfer to a facility
two hours away. He also avoided having to experience a lengthy
hospital stay, as well as the hefty hospital bill for services that
weren't needed. CQCH had similar success after partnering with
Mayo Clinic Scottsdale for its tele-stroke program. More than
three years ago, the Mayo Clinic started the Stroke
Telemedicine Program for Arizona Rural Residents with a grant
from the Arizona Department of Health Services. Medical
studies have shown that stroke victims face a three-hour
window in which the initiation of Tissue Plasminogen
Activator, or TPA, can mean the difference between recovery
and permanent paralysis. The phrase used in stroke programs is
"Time is Brain." Jack Porter, the Mayor of Bisbee, can testify to
TP A effectiveness. When Porter appeared to have suffered a
stroke, he went to the CQCH. A telemedicine consultation with
a Mayo neurologist in Scottsdale less than a half hour later
confirmed the stroke diagnosis, and he ordered that Porter be
started on a course of TPA. The timely treatment prevented any
lasting debilitating effects, and Porter continues to lead the
town as its mayor. When other rural hospitals in Cochise
County recognized the advantages of telemedicine, they and
CQCH formed the Southeast Arizona Telemedicine Association,
or SATA, which includes the following hospitals: Northern
Cochise Community Hospital in Willcox, Benson Community
Hospital, Mount Graham Regional Medical Center in Safford
and Southeast Arizona Medical Center in Douglas. Dickson says
his hospital has not cut care in the wake of rising healthcare
costs, but rather has increased it by making it more efficient.
"By not having the transportation fees and the excessive cost of
re-evaluation at another hospital, we have really spawned a cost
reduction and quality increase in the delivery system," Dickson
says. "Given our success with telemedicine at CQCH, I envision
a virtual hospital in every rural area in America in the near
future so that people will have the care they need and so that
physician misdistribution becomes a problem of the past."
CASE STUDY CHALLENGE:
1. Students should be asked to read the case and discuss all
procedures done during this innovation Telemedicine
Technique.
2. Remark, comment and evaluate the telemedicine
videoconferencing system techniques.
3. Who Benefits from Telemedicine?
4. Will Patients Still Need to See a Specialist in Person?
5. In-person Doctor visit vs. Telemedicine visit, which is
better?
3. Conclusion (15%)
Briefly summarize your thoughts & conclusion to your critique
for the case study. How did these articles and Chapters impact
your thoughts on Telemedicine?
Evaluation will be based on how clearly you respond to the
above, in particular:
a) The clarity with which you critique the chapters.
b) The depth, scope, and organization of your paper; and,
c) Your conclusions, including a description of the impact of
these Chapters on any Healthcare Organization.

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Chapter 15 Risk Management in Ambulatory Care SettingsAm

  • 1. Chapter 15: Risk Management in Ambulatory Care Settings Ambulatory Settings There has been a steady flow of clinical services out of hospital settings into more cost-effective outpatient settings Risk management is as important in the outpatient setting as it is in the inpatient, especially as outpatient settings are not subject to accreditation Of all paid malpractice claims, a greater number are coming from the ambulatory setting than from inpatient alone Why the increased risk? Ambulatory settings differ from inpatient in that they do not have the same mix of specially trained professionals managing patient care 24 hours a day including detailed documentation, observation, decision support teams Ambulatory setting provides infrequent care spread over time and patients are generally seen by personnel with a lower level of training performing tasks in multiple areas Assessment of the Practice Setting Risk Managers need to assess the risks inherent to the specific site Management of risk in the ambulatory setting sites on 3 core principles: A culture of safety Good employment practices Ethical business practices
  • 2. Culture of Safety It is important to recognize that human errors are inevitable and leads to ways to strengthen the system of care rather than punishment 4 Key Features Psychological safety Active leadership Transparency Fairness Good Employment Practices Under the principle of vicarious liability, the facility owner is legally responsible for the actions of their employees Potential risks: Non-physician employee exceeding their legally authorized duties Inappropriate actions of employees Fair employment practice issues Ethical Business Practices The risk manager must guard the practice against fraud and abuse by ensuring Appropriate billing practices Compliance with Stark Law No inappropriate upcoding of claims High Risk Areas Missed diagnoses Medication risks Infectious risks
  • 3. Communication Documentation Office Management Clear and regularly updated policies and procedures wil l help maintain high standards of patient care and lower the risk of lawsuits The Policy and Procedure Manual should be available to all employees and follow the mission, vision and values of the practice setting. Policy Manual Section – Administration Describes the organization of the practice setting Hours of operation Holidays Emergency contact after hours HIPAA Patient Rights (including children) Patient responsibilities Missed appointment policy Patient complaint procedure Transfer of care to another provider Consent forms (including treatment of minors) Advance directives Clarifies HR issues Hiring - Application process, forms and reference checks Verification of credentials and identity Verification of Immunization and TB testing
  • 4. Compliance with employment laws Job descriptions Various employee policies Employee grievance policy Workplace violence policy Disciplinary procedures Employee training Dress code Policy Manual Section – Personnel Policy Manual Section – Records Describes policies and procedures for patient health records Mandated logs Records maintenance Records storage Archiving of hardcopy records Backup of electronic records Documentation of missed appointments and communication of all test results Policy Manual Section – Infection Control Describes policies and procedures to allow personnel to provide safe care and assess infection prevention practices Hand hygiene Personnel protective equipment Injection safety Respiratory hygiene Environmental cleaning Sterilization of equipment Disinfection of reusable instruments
  • 5. Policy Manual Section – Risk Management Describe routine policies needed to cover Potential fraud Lapses in confidentiality Adverse patient outcomes Lawsuits Compliance plan and compliance officer as required by the OIG Policy Manual Section – Quality Management Describes the practice’s policies and procedures for quality control Assessment procedures Improvement plans Summary Ambulatory care settings continue to evolve and face many challenges in patient safety and compliance with laws on business practice. Risk management is essential to meet these challenges. KEISER UNIVERSITY Pembroke Pines Campus BUSINESS ADMINISTRATION DEPARTMENT UPDATED MARCH 8, 2003
  • 6. CAPSTONE PROJECT Project Title xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxx By Student Name Submitted to the Department Director and Faculty in partial fulfillment of the requirements for the degree of BACHELOR OF ARTS IN BUSINESS ADMINISTRATION December 5, 2012
  • 7. CERTIFICATION STATEMENT I hereby certify that this paper constitutes my own product, that where the language of others is set forth, quotation marks so indicate, and that appropriate credit is given where I have used the language, ideas, expressions or writings of another. Signed Student’s Name
  • 9. The abstract must be less than 350 words and should not exceed more than two pages. TABLE OF CONTENTS Page Section INTRODUCTION3 Background3 Rationale for Topic Selection3 Purpose of the Study4 Definition of Terms4 REVIEW OF LITEraTURE5 Introduction5 Sub-topic #25 Sub-topic #35 SUMMARY AND CONCLUSIONS7 Introduction7 Summary of the Study7 Conclusions7 REFERENCES CITED9 BIBLIOGRAPHY10 SECTION I INTRODUCTION Background Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
  • 10. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx.Rationale for Topic Selection Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx. Purpose of the Study Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx.Definition of Terms Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx. 4 Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
  • 11. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx.. SECTION II REVIEW OF LITEraTURE Introduction Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx.Sub-topic #2 Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx.Sub-topic #3 Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx.
  • 12. 5 SECTION III SUMMARY AND CONCLUSIONS Introduction Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx. Summary of the Study Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx.Conclusions Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx.
  • 14. Ambulatory Settings There has been a steady flow of clinical services out of hospital settings into more cost-effective outpatient settings Risk management is as important in the outpatient setting as it is in the inpatient, especially as outpatient settings are not subject to accreditation Of all paid malpractice claims, a greater number are coming from the ambulatory setting than from inpatient alone Why the increased risk? Ambulatory settings differ from inpatient in that they do not have the same mix of specially trained professionals managing patient care 24 hours a day including detailed documentation, observation, decision support teams Ambulatory setting provides infrequent care spread over time and patients are generally seen by personnel with a lower level of training performing tasks in multiple areas Assessment of the Practice Setting Risk Managers need to assess the risks inherent to the specific site Management of risk in the ambulatory setting sites on 3 core principles: A culture of safety Good employment practices Ethical business practices Culture of Safety It is important to recognize that human errors are inevitable and leads to ways to strengthen the system of care rather than punishment 4 Key Features Psychological safety
  • 15. Active leadership Transparency Fairness Good Employment Practices Under the principle of vicarious liability, the facility owner is legally responsible for the actions of their employees Potential risks: Non-physician employee exceeding their legally authorized duties Inappropriate actions of employees Fair employment practice issues Ethical Business Practices The risk manager must guard the practice against fraud and abuse by ensuring Appropriate billing practices Compliance with Stark Law No inappropriate upcoding of claims High Risk Areas Missed diagnoses Medication risks Infectious risks Communication Documentation Office Management
  • 16. Clear and regularly updated policies and procedures will help maintain high standards of patient care and lower the risk of lawsuits The Policy and Procedure Manual should be available to all employees and follow the mission, vision and values of the practice setting. Policy Manual Section – Administration Describes the organization of the practice setting Hours of operation Holidays Emergency contact after hours HIPAA Patient Rights (including children) Patient responsibilities Missed appointment policy Patient complaint procedure Transfer of care to another provider Consent forms (including treatment of minors) Advance directives Clarifies HR issues Hiring - Application process, forms and reference checks Verification of credentials and identity Verification of Immunization and TB testing Compliance with employment laws Job descriptions Various employee policies Employee grievance policy Workplace violence policy Disciplinary procedures
  • 17. Employee training Dress code Policy Manual Section – Personnel Policy Manual Section – Records Describes policies and procedures for patient health records Mandated logs Records maintenance Records storage Archiving of hardcopy records Backup of electronic records Documentation of missed appointments and communication of all test results Policy Manual Section – Infection Control Describes policies and procedures to allow personnel to provide safe care and assess infection prevention practices Hand hygiene Personnel protective equipment Injection safety Respiratory hygiene Environmental cleaning Sterilization of equipment Disinfection of reusable instruments Policy Manual Section – Risk Management Describe routine policies needed to cover Potential fraud
  • 18. Lapses in confidentiality Adverse patient outcomes Lawsuits Compliance plan and compliance officer as required by the OIG Policy Manual Section – Quality Management Describes the practice’s policies and procedures for quality control Assessment procedures Improvement plans Summary Ambulatory care settings continue to evolve and face many challenges in patient safety and compliance with laws on business practice. Risk management is essential to meet these challenges. Chapter 13 Epidemiologic Aspects of Work and the Environment Learning Objectives Define the term environmental epidemiology Give examples of environmental agents that are associated with human health effects Provide examples of study designs used in environmental epidemiology State methodologic difficulties with research on environmental health effects
  • 19. Environmental Epidemiology Study of disease and health conditions (occurring in the population) that are linked to environmental factors Environmental exposures—outside the control of the exposed individual Two Examples of Environmental Catastrophes Deepwater Horizon oil spill, Gulf of Mexico, April 20 to July 15, 2010 Fukushima nuclear reactor meltdown following earthquake in Japan, March 11, 2011 Human Exposures to Environmental Hazards Chemical agents Electromagnetic radiation Ionizing radiation Heavy metals Air pollution Temperature increases from global warming and climate change Health Effects Attributed to Environmental Exposures Cancer Infertility Reproductive impacts Infectious diseases such as malaria Occupation-specific adverse outcomes Study Designs Used Descriptive study designs Helpful for setting priorities Hypothesis formulation
  • 20. Analytic study designs Effects of low-level exposures Exposure-effect relationships Retrospective cohort designs Hazardous Agents in the Work Environment Ionizing radiation Infectious agents Toxic substances Drugs Carcinogenic agents Health Effects Associated with Work Environment Health risks for pregnant workers and the unborn fetus Various lung diseases Dermatologic problems Bladder cancer among dye workers Leukemia among workers exposed to benzene 2 Study Designs Used in Environmental Epidemiology Descriptive studies provide information for setting priorities, identifying hazards, and formulating hypotheses for new occupational risks.
  • 21. Etiologic studies can be used to show exposure-effect relationships. 3 Retrospective Cohort Studies Various end points are used to study the effects of occupational exposures. Morbidity: self-reports of symptoms and results of clinical examinations Mortality: comparison of mortality rates of exposed workers with nonexposed workers in the same industry 4 Collection of Exposure Data Employment records often are used and may include: Personal identifiers to permit record linkage Demographic characteristics Work history Information about potential confounding variables, e.g., medical history, smoking habits
  • 22. 5 The Healthy Worker Effect Observation that employed populations tend to have a lower mortality experience than the general population. The healthy worker effect may reduce the measure of effect for an exposure that increases morbidity or mortality. 6 Ecologic Study Designs One use is the study of the health effects of air pollution. Researchers measure the association between average exposure to air pollution within census tracts and the average mortality in those census tracts. Unable to controI for individual factors, e.g., smoking habits 7
  • 23. Case-Control Studies Compared with cross-sectional study designs, case-control studies can provide more complete exposure data. However, precise quantitation of exposure and unobserved confounding may be difficult to achieve. 8 Toxicologic Concepts Related to Environmental Epidemiology Dose-response Threshold Latency Synergism 9 Dose-Response Curve
  • 24. Graph that is used to assess the effect of exposure to a chemical or toxic substance upon an organism. 10 Threshold The lowest dose at which a particular response may occur 11 Latency The time period between initial exposure and a measurable response Latency can range from seconds (acute toxic agents) to years (mesothelioma). The long latency of health events in environmental research makes the detection of hazards difficult.
  • 25. 12 Synergism A situation in which the combined effect of several exposures is greater than the sum of the individual effects. Example: Study conducted among asbestos insulation workers demonstrated a synergistic relationship between asbestos and smoking in causing lung cancer. 13 Types of Agents Chemical agents Metallic compounds Electric and magnetic fields Ionizing radiation Allergens and molds Dusts Physical and mechanical energy
  • 26. 14 Chemical Agents Many types used at home and at work Household cleaning agents Automotive chemicals Paints Pesticides Bisphenol A (BPA) in plastics Chemical Agents (cont’d) Potential effects on human health through acute toxicity, direct skin irritation, contact dermatitis, or long-term effects such as cancer 15 Pesticides: Used to Control Pests Insecticides Herbicides
  • 27. Rodenticides 16 Four Classes of Insecticides Organophosphates Organocarbamates Pyrethroids Organochlorides (organochlorines) Organochloride Insecticides DDT Toxic to wildlife and persistent in the environment Lindane Chlordane Chemical Agents (cont’d) Asbestos Strictly speaking, a mineral fiber Was used commonly for ship building, construction, insulation, and automobiles Associated with asbestosis, mesothelioma, and lung cancer Metallic Compounds Arsenic Mercury
  • 28. Lead Metallic Compounds (cont’d) Arsenic A crystalline metalloid Exists as inorganic compounds in the environment Many uses Used as a preservative for residential lumber outlawed Potential carcinogen, e.g., bladder cancer Metallic Compounds (cont’d) Mercury Used for the treatment of syphilis, as an agricultural fungicide, and in dental amalgams Responsible for Minamata disease, which occurred in the mid- 1950s in Minamata Bay, Japan A neurological condition linked to the consumption of fish contaminated with mercury 17 Metallic Compounds (cont’d) Lead Once widely used in paint and gasoline
  • 29. Associated with serious central nervous system effects even at low levels Has adverse effects on intelligence, behavior, and development Between 1988 and 2002, percentage of children with elevated blood lead levels declined steeply 18 Electric and Magnetic Fields Sources include power lines, microwave ovens, stoves, clocks, cellular phones. Los Angeles and Swedish studies found an association between residential proximity to power lines and childhood cancer risk. U.S. and Norwegian studies found an increased risk for male breast cancer among male electrical workers. 19 Ionizing Radiation Consists of either particle energy (e.g., highly energetic protons, neutrons, and α and β particles) or electromagnetic energy (e.g., γ-rays and X-rays)
  • 30. Sources of ionizing radiation can be natural or synthetic. 20 Ionizing Radiation (cont’d) Natural sources--examples are radon and cosmic rays. Radon is one of the largest sources of human exposure to ionizing radiation and may be the cause of about 21,000 deaths from lung cancers in the U.S. Synthetic sources--examples are medical x-rays and nuclear generators. Allergens and Molds Allergens--substances that provoke an allergic reaction in susceptible individuals Allergic reactions range from dermatitis, asthma, and itchy eyes to anaphylactic shock. 21 Physical and Mechanical Energy
  • 31. Include agents associated with unintentional injuries Unintentional injuries are a leading cause of death within the age group 1-44 years in the U.S. Also include such factors as noise, vibration, and extremes of temperature 22 Global Warming Possible association with extreme heat waves Climate changes in the eastern U.S. Deaths associated with heat waves Monitoring and Surveillance of Occupational Hazards Hazard surveillance--characterization of known chemical, physical, and biologic agents in the workplace Sentinel health event--a case of unnecessary disease, unnecessary disability, or untimely death whose occurrence is a warning signal that the quality of preventive or medical care may need to be improved 23
  • 32. Environmental Hazards Found in the Work Setting Biologic hazards--Hospital employees, sewage workers, and agricultural workers may be exposed to hazardous biologic agents. For example, HIV may infect hospital workers through accidental needle sticks. Mineral and organic dusts--Examples include coal dust (mining and black lung disease) and rubber dust (COPD). 24 Environmental Hazards Found in the Work Setting (cont’d) Vapors and fumes are likely to become increasing hazards due to the growing use of chemical substances. Vapors--Include organic solvents such as benzene, which may cause cancer and damage internal organs (particularly the liver) 25 Mineral and Organic Dusts Silicosis Pulmonary emphysema
  • 33. Chronic obstructive disease Coal workers’ pneumoconiosis Industrial Chemicals Exposure in occupational settings is up to 100 times higher than in the ambient environment. Vinyl chloride—angiosarcoma of the liver Pesticides Noteworthy Community Environmental Health Hazards Hazardous waste sites Air pollution Nuclear facilities Drinking water 27 Sick Building Syndrome Dryness of the skin and mucous membranes Mental fatigue Headaches Symptoms diminish when affected person leaves the building.
  • 34. Hazardous Waste Sites Notorious sites in the U.S. include: Love Canal, NY; Valley of the Drums, KY; Times Beach, MO; Stringfellow acid pits, CA; Casmalia Waste Disposal Facility, CA. Of great concern is the contamination of water supplies by toxic wastes. Some possible adverse effects of hazardous waste exposure include birth defects, neurologic disease, and cancer. 28 Air Pollution Constituents of air pollution include sulfur oxides, particles, ozone, and lead and other heavy metals. Lethal air pollution episodes have occurred worldwide. Studies conducted in New York City, St. Louis, and Tennessee have shown a correlation between increases in daily mortality and increased air pollution. 29
  • 35. Environmental Tobacco Smoke (ETS) Nonsmokers who work in a smoking environment have reduced pulmonary function compared to nonsmokers in a smoke-free work environment. ETS causes 3,000 lung cancer deaths annually among nonsmokers. ETS is associated with children’s bronchitis, pneumonia, and asthma. 30 Nuclear Facilities Include weapons production plants, test sites, and nuclear power plants Studies of living in close proximity to nuclear installations have shown conflicting results regarding cancer rates. Following the Chernobyl nuclear power plant accident, thyroid cancer rates increased near the reactor. 31 Drinking Water
  • 36. Chemical plants and nuclear facilities may contaminate ground water. Chlorination of water supply has helped to decrease the incidence of gastroenteric diseases. Lead and asbestos particles may be present in water and have potential for toxicity. 32 Chapter 13 Epidemiologic Aspects of Work and the Environment Learning Objectives Define the term environmental epidemiology Give examples of environmental agents that are associated with human health effects Provide examples of study designs used in environmental epidemiology State methodologic difficulties with research on environmental health effects Environmental Epidemiology Study of disease and health conditions (occurring in the population) that are linked to environmental factors Environmental exposures—outside the control of the exposed individual
  • 37. Two Examples of Environmental Catastrophes Deepwater Horizon oil spill, Gulf of Mexico, April 20 to July 15, 2010 Fukushima nuclear reactor meltdown following earthquake in Japan, March 11, 2011 Human Exposures to Environmental Hazards Chemical agents Electromagnetic radiation Ionizing radiation Heavy metals Air pollution Temperature increases from global warming and climate change Health Effects Attributed to Environmental Exposures Cancer Infertility Reproductive impacts Infectious diseases such as malaria Occupation-specific adverse outcomes Study Designs Used Descriptive study designs Helpful for setting priorities Hypothesis formulation Analytic study designs Effects of low-level exposures Exposure-effect relationships Retrospective cohort designs Hazardous Agents in the Work Environment
  • 38. Ionizing radiation Infectious agents Toxic substances Drugs Carcinogenic agents Health Effects Associated with Work Environment Health risks for pregnant workers and the unborn fetus Various lung diseases Dermatologic problems Bladder cancer among dye workers Leukemia among workers exposed to benzene 2 Study Designs Used in Environmental Epidemiology Descriptive studies provide information for setting priorities, identifying hazards, and formulating hypotheses for new occupational risks. Etiologic studies can be used to show exposure-effect relationships. 3
  • 39. Retrospective Cohort Studies Various end points are used to study the effects of occupational exposures. Morbidity: self-reports of symptoms and results of clinical examinations Mortality: comparison of mortality rates of exposed workers with nonexposed workers in the same industry 4 Collection of Exposure Data Employment records often are used and may include: Personal identifiers to permit record linkage Demographic characteristics Work history Information about potential confounding variables, e.g., medical history, smoking habits 5
  • 40. The Healthy Worker Effect Observation that employed populations tend to have a lower mortality experience than the general population. The healthy worker effect may reduce the measure of effect for an exposure that increases morbidity or mortality. 6 Ecologic Study Designs One use is the study of the health effects of air pollution. Researchers measure the association between average exposure to air pollution within census tracts and the average mortality in those census tracts. Unable to controI for individual factors, e.g., smoking habits 7 Case-Control Studies Compared with cross-sectional study designs, case-control
  • 41. studies can provide more complete exposure data. However, precise quantitation of exposure and unobserved confounding may be difficult to achieve. 8 Toxicologic Concepts Related to Environmental Epidemiology Dose-response Threshold Latency Synergism 9 Dose-Response Curve Graph that is used to assess the effect of exposure to a chemical or toxic substance upon an organism. 10
  • 42. Threshold The lowest dose at which a particular response may occur 11 Latency The time period between initial exposure and a measurable response Latency can range from seconds (acute toxic agents) to years (mesothelioma). The long latency of health events in environmental research makes the detection of hazards difficult. 12
  • 43. Synergism A situation in which the combined effect of several exposures is greater than the sum of the individual effects. Example: Study conducted among asbestos insulation workers demonstrated a synergistic relationship between asbestos and smoking in causing lung cancer. 13 Types of Agents Chemical agents Metallic compounds Electric and magnetic fields Ionizing radiation Allergens and molds Dusts Physical and mechanical energy 14 Chemical Agents
  • 44. Many types used at home and at work Household cleaning agents Automotive chemicals Paints Pesticides Bisphenol A (BPA) in plastics Chemical Agents (cont’d) Potential effects on human health through acute toxicity, direct skin irritation, contact dermatitis, or long-term effects such as cancer 15 Pesticides: Used to Control Pests Insecticides Herbicides Rodenticides 16
  • 45. Four Classes of Insecticides Organophosphates Organocarbamates Pyrethroids Organochlorides (organochlorines) Organochloride Insecticides DDT Toxic to wildlife and persistent in the environment Lindane Chlordane Chemical Agents (cont’d) Asbestos Strictly speaking, a mineral fiber Was used commonly for ship building, construction, insulation, and automobiles Associated with asbestosis, mesothelioma, and lung cancer Metallic Compounds Arsenic Mercury Lead Metallic Compounds (cont’d) Arsenic A crystalline metalloid Exists as inorganic compounds in the environment
  • 46. Many uses Used as a preservative for residential lumber outlawed Potential carcinogen, e.g., bladder cancer Metallic Compounds (cont’d) Mercury Used for the treatment of syphilis, as an agricultural fungicide, and in dental amalgams Responsible for Minamata disease, which occurred in the mid- 1950s in Minamata Bay, Japan A neurological condition linked to the consumption of fish contaminated with mercury 17 Metallic Compounds (cont’d) Lead Once widely used in paint and gasoline Associated with serious central nervous system effects even at low levels Has adverse effects on intelligence, behavior, and development Between 1988 and 2002, percentage of children with elevated blood lead levels declined steeply
  • 47. 18 Electric and Magnetic Fields Sources include power lines, microwave ovens, stoves, clocks, cellular phones. Los Angeles and Swedish studies found an association between residential proximity to power lines and childhood cancer risk. U.S. and Norwegian studies found an increased risk for mal e breast cancer among male electrical workers. 19 Ionizing Radiation Consists of either particle energy (e.g., highly energetic protons, neutrons, and α and β particles) or electromagnetic energy (e.g., γ-rays and X-rays) Sources of ionizing radiation can be natural or synthetic. 20
  • 48. Ionizing Radiation (cont’d) Natural sources--examples are radon and cosmic rays. Radon is one of the largest sources of human exposure to ionizing radiation and may be the cause of about 21,000 deaths from lung cancers in the U.S. Synthetic sources--examples are medical x-rays and nuclear generators. Allergens and Molds Allergens--substances that provoke an allergic reaction in susceptible individuals Allergic reactions range from dermatitis, asthma, and itchy eyes to anaphylactic shock. 21 Physical and Mechanical Energy Include agents associated with unintentional injuries Unintentional injuries are a leading cause of death within the age group 1-44 years in the U.S. Also include such factors as noise, vibration, and extremes of temperature
  • 49. 22 Global Warming Possible association with extreme heat waves Climate changes in the eastern U.S. Deaths associated with heat waves Monitoring and Surveillance of Occupational Hazards Hazard surveillance--characterization of known chemical, physical, and biologic agents in the workplace Sentinel health event--a case of unnecessary disease, unnecessary disability, or untimely death whose occurrence is a warning signal that the quality of preventive or medical care may need to be improved 23 Environmental Hazards Found in the Work Setting Biologic hazards--Hospital employees, sewage workers, and agricultural workers may be exposed to hazardous biologic agents. For example, HIV may infect hospital workers through accidental needle sticks.
  • 50. Mineral and organic dusts--Examples include coal dust (mining and black lung disease) and rubber dust (COPD). 24 Environmental Hazards Found in the Work Setting (cont’d) Vapors and fumes are likely to become increasing hazards due to the growing use of chemical substances. Vapors--Include organic solvents such as benzene, which may cause cancer and damage internal organs (particularly the liver) 25 Mineral and Organic Dusts Silicosis Pulmonary emphysema Chronic obstructive disease Coal workers’ pneumoconiosis Industrial Chemicals Exposure in occupational settings is up to 100 times higher than in the ambient environment.
  • 51. Vinyl chloride—angiosarcoma of the liver Pesticides Noteworthy Community Environmental Health Hazards Hazardous waste sites Air pollution Nuclear facilities Drinking water 27 Sick Building Syndrome Dryness of the skin and mucous membranes Mental fatigue Headaches Symptoms diminish when affected person leaves the building. Hazardous Waste Sites Notorious sites in the U.S. include: Love Canal, NY; Valley of the Drums, KY; Times Beach, MO; Stringfellow acid pits, CA; Casmalia Waste Disposal Facility, CA. Of great concern is the contamination of water supplies by toxic wastes.
  • 52. Some possible adverse effects of hazardous waste exposure include birth defects, neurologic disease, and cancer. 28 Air Pollution Constituents of air pollution include sulfur oxides, particles, ozone, and lead and other heavy metals. Lethal air pollution episodes have occurred worldwide. Studies conducted in New York City, St. Louis, and Tennessee have shown a correlation between increases in daily mortality and increased air pollution. 29 Environmental Tobacco Smoke (ETS) Nonsmokers who work in a smoking environment have reduced pulmonary function compared to nonsmokers in a smoke-free work environment. ETS causes 3,000 lung cancer deaths annually among nonsmokers. ETS is associated with children’s bronchitis, pneumonia, and
  • 53. asthma. 30 Nuclear Facilities Include weapons production plants, test sites, and nuclear power plants Studies of living in close proximity to nuclear installations have shown conflicting results regarding cancer rates. Following the Chernobyl nuclear power plant accident, thyroid cancer rates increased near the reactor. 31 Drinking Water Chemical plants and nuclear facilities may contaminate ground water. Chlorination of water supply has helped to decrease the incidence of gastroenteric diseases. Lead and asbestos particles may be present in water and have potential for toxicity.
  • 54. 32 Chapter 14 Molecular and Genetic Epidemiology Learning Objectives Differentiate between molecular and genetic epidemiology Describe principles of inheritance and sources of genetic variation Define epidemiologic approaches for the identification of genetic components to disease Peeking into the “Black Box” Many risk factors can be quantified through questionnaires, records, and easily measured attributes (such as blood pressure and anthropometrics). The biological mechanism(s) through which these factors influence disease is not always apparent (i.e., a “black box”). Value of Mechanistic Insight Biologic plausibility is a criterion for causality. Linking lifestyle risk factors with measures of biologic effect strengthens interpretations of causality. This linkage, in turn, provides stronger support for interventions.
  • 55. Why Distinguish Between Molecular and Genetic Epidemiology? The basic tenets and principles of molecular and genetic epidemiology are the same. However, there are specific features regarding design, analysis and interpretation inherent in the latter. 3 Definition of Genetic Epidemiology A discipline that seeks to unravel the role of genetic factors and their interactions with environmental factors in the etiology of diseases, using family and population study approaches. 4 Key Aspects of This Definition Inherited susceptibility does not mean inherited disease-- environment matters! When families are studied, the observations (study subjects) are no longer independent. This dependence requires special considerations for the analysis of data.
  • 56. 5 Genetic Epidemiology is a Method to Answer: Does a disease cluster in families? If so, is that clustering likely a result of shared non-genetic risk factors? If the clustering is not accounted for by shared lifestyle or common environment, is the pattern of disease consistent with inherited effects? If so, where is the putative gene? 6 What Diseases or Risk Factors Cluster in Families? Heart disease Various cancers Alcoholism Others Epidemiologic Assessment of Clustering Case-control study Comparison of the frequency of a positive family history Expectation under genetic influence Clustering of “Non-Genetic” Exposures in Families
  • 57. Employment (e.g., several family members with medical degrees) Radon from soil Religious preferences Lead in paint Others? 7 Major Point of This Section You cannot tell easily whether clustering of a risk factor or disease within a family is due to genetics, culture, or shared environment (including social or political factors). Clustering within a family will also occur simply due to bad luck! 8 Other Correlates of Family History Large family size Age of relatives (for an age-related disease) Gender distribution (consider testicular cancer, prostate disease, ovarian cysts) Analysis Approach
  • 58. Model Y (case/control status) = established risk factors. Add family history variable to denote “genetic” influence (i.e., share genes with an individual who has the outcome of interest). Analysis Issues Try to compare (and control if necessary) differences between cases and controls with regard to size of family. Not easy to adjust for age of family members or their risk factors. What types of data can you ask your cases and controls to provide about their relatives? Motivation for Case-Control Family Studies To rule out influence of shared environment, family size differences, and age on differences in the frequency of family history between cases and controls Need to enumerate the relatives of cases and controls, and determine the disease status and risk factor profile for each relative Conduct of Family Studies Ascertain “probands” (index cases). Define family (siblings? children? parents? grandparents?) Invite family members to participate Collect data (and, typically, biological samples) How to Select Control Families Must decide how to identify controls From spouse’s side of proband’s family? Or select a random sample from the population? Will controls be motivated to participate? Must take HIPAA rules into account
  • 59. Analysis Issues Exclude the index cases and controls Model disease (or behavior) of interest based on age, sex, known risk factors Evaluate evidence for genetic effect through statistical significance of variable(s) that indicate “relationship to index case” Analysis Issues (cont’d) Simplest “genetic” variable (1 if relative of case, 0 if relative of control) Can also construct indicator variables to designate type of relative (parent, sibling, more distant relative) If not significant after including other risk factors, then no evidence for genetic influence Evidence of Genetic Influence, so far…. Cases are more likely to have a family history of disease than controls. The excess risk to relatives is not accounted for by age, sex, and other risk factors. What does that tell us about the underlying genetic influence? (nothing) Other Approaches to Identify Genetic Influences Twin studies Segregation analysis Linkage analysis Twin Studies
  • 60. A “natural experiment” of sorts Monozygotic (MZ) twins are genetically identical. Dizygotic (DZ) twins share, on average, the same proportion of genes as siblings. Greater concordance (for dichotomous traits) or correlation (for continuous traits) for MZ than DZ twins is evidence of a genetic influence. 9 Linkage Analysis One way to distinguish cultural inheritance from genetic inheritance is to track a region of our DNA that is transmitted from parents to offspring in the same manner as the disease/outcome of interest. This procedure works well for diseases that follow simple rules of inheritance (e.g., autosomal dominant or recessive). 10 Segregation Analysis Historically, linkage analysis required knowledge of the mode of transmission of the putative gene [dominant versus recessive, allele frequency, lifetime or age-specific risk (penetrance)]. Segregation analysis has been used to estimate these parameters.
  • 61. Genetic Epidemiology of Complex Diseases “Complex diseases” are ones for which the genetic influence may be modest and environmental factors contribute to disease risk. Segregation analysis is not typically done for “complex diseases.” Modern approaches ignore models of inheritance (non- parametric methods). Use of Epidemiology to Understand Genetic Variation The methods of genetic epidemiology have been applied historically to identify genes. Typically, epidemiologists are not interested in mapping genes, but rather in figuring out how genes interact with environment to influence disease risk and outcome. Molecular Epidemiology Related individuals are not necessarily required for studies of the association of genetic variation with risk of disease. Both cohort and case-control designs can be used. Because genetic code (germline DNA) is unchanged since conception, one readily can employ retrospective designs. Common Strategies for Genetic Marker Selection Genome-wide approach with anonymous DNA markers (1,000,000 SNPs on a chip) SNPs or simple tandem repeat markers in “candidate” genes based on a priori knowledge about presumed function SNPs in candidate genes with known functional effect on level or activity of protein product
  • 62. Primer on Single Nucleotide Polymorphis ms (SNPs) Because of our redundant genetic code, some SNPs will not alter the encoded amino acid (e.g., GGA, GGG, GGT and GGC all encode proline). SNPs that change an amino acid may not necessarily lead to change in function of transcribed protein. More on SNPs SNPs that don’t change an amino acid may still lead to alternate splicing of the transcript (and therefore be functionally important). SNPs in promoter region may influence level of protein product–not activity (and therefore be biologically significant). SNPs in non-coding regions may still have functional effect. Caveats About SNP Studies If you’re interested in gene x environment interactions–best to focus on SNPs with known functional effect. Human biology is complex: are alterations in one component of a pathway compensated for by another? Most SNPs are likely to be modest risk factors–requiring large sample sizes to determine statistically significant association. Realistic Expectations Almost every gene is modified after translation into protein (e.g., glycosylation, acetylation, methylation). Thus, the correlation between DNA sequence and protein is far from perfect. Most GWAS “hits” are in “gene deserts.” May be necessary to examine multiple SNPs within a gene and several genes within a pathway.
  • 63. Molecular Epidemiology – Beyond Genetics Biomarkers of exposure and disease extend beyond DNA. Viral or bacterial load Morphometric analysis of tissues/cells Hormone or lipid levels in blood or urine Other examples? Conclusion Molecular and genetic epidemiology represent specialty areas of expertise. These specialty areas utilize and apply advances in molecular biology and molecular genetics of disease to: Unravel disease etiology. Enable novel approaches for early detection. Inform more effective interventions by targeting those at greatest risk. Chapter 14 Molecular and Genetic Epidemiology Learning Objectives Differentiate between molecular and genetic epidemiology Describe principles of inheritance and sources of genetic variation Define epidemiologic approaches for the identification of genetic components to disease Peeking into the “Black Box” Many risk factors can be quantified through questionnaires,
  • 64. records, and easily measured attributes (such as blood pressure and anthropometrics). The biological mechanism(s) through which these factors influence disease is not always apparent (i.e., a “black box”). Value of Mechanistic Insight Biologic plausibility is a criterion for causality. Linking lifestyle risk factors with measures of biologic effect strengthens interpretations of causality. This linkage, in turn, provides stronger support for interventions. Why Distinguish Between Molecular and Genetic Epidemiology? The basic tenets and principles of molecular and genetic epidemiology are the same. However, there are specific features regarding design, analysis and interpretation inherent in the latter. 3 Definition of Genetic Epidemiology A discipline that seeks to unravel the role of genetic factors and their interactions with environmental factors in the etiology of diseases, using family and population study approaches. 4
  • 65. Key Aspects of This Definition Inherited susceptibility does not mean inherited disease-- environment matters! When families are studied, the observations (study subjects) are no longer independent. This dependence requires special considerations for the analysis of data. 5 Genetic Epidemiology is a Method to Answer: Does a disease cluster in families? If so, is that clustering likely a result of shared non-genetic risk factors? If the clustering is not accounted for by shared lifestyle or common environment, is the pattern of disease consistent with inherited effects? If so, where is the putative gene? 6 What Diseases or Risk Factors Cluster in Families?
  • 66. Heart disease Various cancers Alcoholism Others Epidemiologic Assessment of Clustering Case-control study Comparison of the frequency of a positive family history Expectation under genetic influence Clustering of “Non-Genetic” Exposures in Families Employment (e.g., several family members with medical degrees) Radon from soil Religious preferences Lead in paint Others? 7 Major Point of This Section You cannot tell easily whether clustering of a risk factor or disease within a family is due to genetics, culture, or shared environment (including social or political factors). Clustering within a family will also occur simply due to bad luck!
  • 67. 8 Other Correlates of Family History Large family size Age of relatives (for an age-related disease) Gender distribution (consider testicular cancer, prostate disease, ovarian cysts) Analysis Approach Model Y (case/control status) = established risk factors. Add family history variable to denote “genetic” influence (i.e., share genes with an individual who has the outcome of interest). Analysis Issues Try to compare (and control if necessary) differences between cases and controls with regard to size of family. Not easy to adjust for age of family members or their risk factors. What types of data can you ask your cases and controls to provide about their relatives? Motivation for Case-Control Family Studies To rule out influence of shared environment, family size differences, and age on differences in the frequency of family history between cases and controls Need to enumerate the relatives of cases and controls, and determine the disease status and risk factor profile for each relative
  • 68. Conduct of Family Studies Ascertain “probands” (index cases). Define family (siblings? children? parents? grandparents?) Invite family members to participate Collect data (and, typically, biological samples) How to Select Control Families Must decide how to identify controls From spouse’s side of proband’s family? Or select a random sample from the population? Will controls be motivated to participate? Must take HIPAA rules into account Analysis Issues Exclude the index cases and controls Model disease (or behavior) of interest based on age, sex, known risk factors Evaluate evidence for genetic effect through statistical significance of variable(s) that indicate “relationship to index case” Analysis Issues (cont’d) Simplest “genetic” variable (1 if relative of case, 0 if relative of control) Can also construct indicator variables to designate type of relative (parent, sibling, more distant relative) If not significant after including other risk factors, then no evidence for genetic influence Evidence of Genetic Influence, so far…. Cases are more likely to have a family history of disease than controls.
  • 69. The excess risk to relatives is not accounted for by age, sex, and other risk factors. What does that tell us about the underlying genetic influence? (nothing) Other Approaches to Identify Genetic Influences Twin studies Segregation analysis Linkage analysis Twin Studies A “natural experiment” of sorts Monozygotic (MZ) twins are genetically identical. Dizygotic (DZ) twins share, on average, the same proportion of genes as siblings. Greater concordance (for dichotomous traits) or correlation (for continuous traits) for MZ than DZ twins is evidence of a genetic influence. 9 Linkage Analysis One way to distinguish cultural inheritance from genetic inheritance is to track a region of our DNA that is transmitted from parents to offspring in the same manner as the disease/outcome of interest. This procedure works well for diseases that follow simple rules of inheritance (e.g., autosomal dominant or recessive).
  • 70. 10 Segregation Analysis Historically, linkage analysis required knowledge of the mode of transmission of the putative gene [dominant versus recessive, allele frequency, lifetime or age-specific risk (penetrance)]. Segregation analysis has been used to estimate these parameters. Genetic Epidemiology of Complex Diseases “Complex diseases” are ones for which the genetic influence may be modest and environmental factors contribute to disease risk. Segregation analysis is not typically done for “complex diseases.” Modern approaches ignore models of inheritance (non- parametric methods). Use of Epidemiology to Understand Genetic Variation The methods of genetic epidemiology have been applied historically to identify genes. Typically, epidemiologists are not interested in mapping genes, but rather in figuring out how genes interact with environment to influence disease risk and outcome. Molecular Epidemiology Related individuals are not necessarily required for studies of the association of genetic variation with risk of disease.
  • 71. Both cohort and case-control designs can be used. Because genetic code (germline DNA) is unchanged since conception, one readily can employ retrospective designs. Common Strategies for Genetic Marker Selection Genome-wide approach with anonymous DNA markers (1,000,000 SNPs on a chip) SNPs or simple tandem repeat markers in “candidate” genes based on a priori knowledge about presumed function SNPs in candidate genes with known functional effect on level or activity of protein product Primer on Single Nucleotide Polymorphisms (SNPs) Because of our redundant genetic code, some SNPs will not alter the encoded amino acid (e.g., GGA, GGG, GGT and GGC all encode proline). SNPs that change an amino acid may not necessarily lead to change in function of transcribed protein. More on SNPs SNPs that don’t change an amino acid may still lead to alternate splicing of the transcript (and therefore be functionally important). SNPs in promoter region may influence level of protein product–not activity (and therefore be biologically significant). SNPs in non-coding regions may still have functional effect. Caveats About SNP Studies If you’re interested in gene x environment interactions–best to focus on SNPs with known functional effect. Human biology is complex: are alterations in one component of a pathway compensated for by another?
  • 72. Most SNPs are likely to be modest risk factors–requiring large sample sizes to determine statistically significant association. Realistic Expectations Almost every gene is modified after translation into protein (e.g., glycosylation, acetylation, methylation). Thus, the correlation between DNA sequence and protein is far from perfect. Most GWAS “hits” are in “gene deserts.” May be necessary to examine multiple SNPs within a gene and several genes within a pathway. Molecular Epidemiology – Beyond Genetics Biomarkers of exposure and disease extend beyond DNA. Viral or bacterial load Morphometric analysis of tissues/cells Hormone or lipid levels in blood or urine Other examples? Conclusion Molecular and genetic epidemiology represent specialty areas of expertise. These specialty areas utilize and apply advances in molecular biology and molecular genetics of disease to: Unravel disease etiology. Enable novel approaches for early detection. Inform more effective interventions by targeting those at greatest risk. Chapter 14: Telemedicine
  • 73. Telemedicine The collection and communication of healthcare information over a distance via telecommunication and/or information systems from one site to another. Telemedicine is not the same as the following terms and should not be used interchangeably: telehealth m-health e-health Telemedicine Services Patient Consultation Specialist Referral Service Remote Patient Monitoring Consumer Medical and Health Information and Social Media Telenursing Telepharmacy Telerehabilitation Emergency Telemedicine Risk Management and Telemedicine Many risks remain the same whether the patient is in the same room as the provider or at a distance Adding to the risks are Lack of study data on telemedicine Variability of state regulations Lack of significant case law Lack of significant claims studies Clinical Care Risks Risks inherent to clinical specialty remain the same when
  • 74. utilizing telemedicine with the addition of Patient non-compliance without the knowledge of the provider Patient misinterpretation or inability to relate his condition to the provider Inability of patient to recall or understand directions Clinician misinterpretation of the data Medication errors Administrative Risks Administration must evaluate the effectiveness and safety of telemedicine. Is it adding to or detracting from the quality of care? Is it increasing or decreasing morbidity and mortality? Examples of Administrative Risks Lack of appropriate operational policies Lack of quality improvement, patient safety and risk management programs Inconsistent or incomplete understanding of the patient-provider relationship Integration of the telemedicine into the workflow Appropriate communication and chain of command Appropriate documentation Adverse event notification Technological Risks Equipment and function do not meet the need If equipment and function meet the need, performance does not Derived data are or become corrupt or unlawfully shared Consumer Medical and Health Information Services
  • 75. and Social Media Risks Use of social media has increased the risk to health facilities: Lack of case law for guidance Potential HIPAA violations Healthcare facility should develop a consumer health education and social media plan Summary Telemedicine is an expanding service with increased risk for the healthcare organization As there are few evidence-based studies regarding effectiveness and no case law, risk managers must be vigilant and monitor their telemedicine services for potential risk to the organiza tion Chapter 14: Telemedicine Telemedicine The collection and communication of healthcare information over a distance via telecommunication and/or information systems from one site to another. Telemedicine is not the same as the following terms and should not be used interchangeably: telehealth m-health e-health Telemedicine Services Patient Consultation Specialist Referral Service Remote Patient Monitoring
  • 76. Consumer Medical and Health Information and Social Media Telenursing Telepharmacy Telerehabilitation Emergency Telemedicine Risk Management and Telemedicine Many risks remain the same whether the patient is in the same room as the provider or at a distance Adding to the risks are Lack of study data on telemedicine Variability of state regulations Lack of significant case law Lack of significant claims studies Clinical Care Risks Risks inherent to clinical specialty remain the same when utilizing telemedicine with the addition of Patient non-compliance without the knowledge of the provider Patient misinterpretation or inability to relate his condition to the provider Inability of patient to recall or understand directions Clinician misinterpretation of the data Medication errors Administrative Risks Administration must evaluate the effectiveness and safety of telemedicine. Is it adding to or detracting from the quality of care? Is it increasing or decreasing morbidity and mortality?
  • 77. Examples of Administrative Risks Lack of appropriate operational policies Lack of quality improvement, patient safety and risk management programs Inconsistent or incomplete understanding of the patient-provider relationship Integration of the telemedicine into the workflow Appropriate communication and chain of command Appropriate documentation Adverse event notification Technological Risks Equipment and function do not meet the need If equipment and function meet the need, performance does not Derived data are or become corrupt or unlawfully shared Consumer Medical and Health Information Services and Social Media Risks Use of social media has increased the risk to health facilities: Lack of case law for guidance Potential HIPAA violations Healthcare facility should develop a consumer health education and social media plan Summary Telemedicine is an expanding service with increased risk for the healthcare organization As there are few evidence-based studies regarding effectiveness and no case law, risk managers must be vigilant and monitor their telemedicine services for potential risk to the organization
  • 78. HSA-6520 Managerial Epidemiology: Week 6 Human Environmental Impact at Work: Epidemiology: Chapters 13 to 14 Objective: To critically reflect your understanding of the readings and your ability to apply them to your Health care Setting. ASSIGNMENT GUIDELINES (10%): Human Environmental Impact at Work: Epidemiology. For this assignment, you are encourage to choose any Job Position from the Health Care area and critically evaluate, state and describe the more notable exposures and remediation hazards agent that can affect your choosing position. The paper will be 3-5 pages long. Each paper must be typewritten with 12-point font and double-spaced with standard margins. Follow APA style 7Th edition format when referring to the selected articles and include a reference page. EACH PAPER SHOULD INCLUDE THE FOLLOWING: 1. Introduction (25%) Provide a short-lived outline of the definition of the term environmental epidemiology and give examples of environmental agents that are associated with human health effects. 2. Human Environmental Impact at Work (50%): For this assignment you are heartened to choose any Job Position from the Health Care area and judgmentally assess, state and designate the more distinguished exposures and remediation hazards agent that can distress the job position of your choosing. a. Health Effects associated with environmental Hazards. b. Toxicology Concepts Related to Environmental Epidemiology. c. Types of agents and effect on Human Health 3. Conclusion (16%)
  • 79. Fleetingly summarize your thoughts & deduction to your appraisal of the articles and Chapter you read. How did these articles and Chapters impact your thoughts on Environmental epidemiology and its importance? Evaluation will be based on how evidently you respond to the above, in particular: a) The meticulousness with which you assessment the articles; b) The profundity, choice, and association of your paper; and, c) Your conclusions, including a description of the impact of these articles and Chapters on any Health Care Setting. HAS-6505 Health Care Risk Management: Assignment Week 6 Case Study: Chapters 14 & 15 Objective: To judgmentally reveal your knowledge of Telemedicine Services, Risk management Tactics and your ability to apply them to your Healthcare Organizatio ns. The investigative exercises will progress students’ understanding and skill to think censoriously about the public relations process, and their problem-solving skills. As a result of this assignment, students will be better able to comprehend, examine and apply Telemedicine to Health care organizations. ASSIGNMENT GUIDELINES (10%): The students will complete A Case study projects that give the opportunity to create and apply the concepts learned in this and previous coursework to analyze a real-world scenario. This scenario will represent through example the practical importance and implications of various roles and functions of a Health Care Administrator and Risk Management. The assignment will be 3-4 pages long reflecting your understanding and ability to apply the readings to your Healthcare Organization. Each paper must be typewritten with 12-point font and double-spaced with standard margins. Follow APA style 7th edition format when referring to the selected articles and include a reference page. EACH PAPER SHOULD INCLUDE THE FOLLOWING:
  • 80. 1. Introduction (25%) Provide a brief synopsis of the meaning (not a description) of each Chapter read, in your own words. 2. Your Critique (50%) Case Study: Telemedicine technology solves healthcare disparity i ssue in rural Arizona community Bisbee's Copper Queen Community Hospital implements successful telemedicine program, drastically reducing cost and time spent on patient care Background Founded in 1880, Bisbee is located in the rolling hills of the Mule Mountains in southeastern Arizona, some 85 miles from Tucson, and within three miles of the border with Mexico. The region's rich mineral deposits of copper, gold and silver first attracted miners who hoped to strike it rich. The town that developed around the mines was named for DeWitt Bisbee, a San Francisco Judge and investor in the Copper Queen Mine who, ironically, never set foot in his namesake. Nearly as old as Bisbee, the Copper Queen Hospital got its start in a mine tunnel as part of the mining community. Now known as the Copper Queen Community Hospital (CQCH), it has served the town for over 125 years. In more recent times, CQCH has become an acute care critical access hospital for the more than 6,000-plus Bisbee residents and for many of the county's 140,000 residents. The hospital's mission is to maintain and support access to basic primary healthcare throughout southeastern Cochise County and to evolve rural health care and provide patients with the highest quality services. Challenge Among the primary challenges of CQCH was how to provide care for patients who needed specialists. For years, emergency department patients with possible cardiac or stroke problems had to be transferred to Tucson and Phoenix hospitals by ambulance, or " in more life- threatening situations " by helicopter. CQCH patients often discovered after the fact that, although healthcare was warranted, the expense of emergency
  • 81. transfer was not. "Cardiology disease is the number one killer of people in rural areas," said CQCH CEO, James Dickson. "And in Bisbee, we lacked consistent care to treat it. We lacked access to a cardiologist and to the ongoing maintenance care required after initial treatment. We decided we needed a way to solve the physician misdistribution and disease management problems that occur in a rural area like Bisbee." In 2009, CQCH received a grant to begin a telemedicine cardiology program. Dickson set out to find a system that would essentially bring specialists into Bisbee and CQCH without requiring that they physically be on site. This would eliminate the costly transfer of patients to Tucson and Phoenix. It would also minimize the trauma involved for family members of those being transported far distances. Overall, the implementation of a telemedicine program would shrink the disparity in healthcare experienced by the people of Bisbee by making specialists vastly more within reach without the price tag of on site consultations. Solution Dickson and CQCH worked with telemedicine solutions provider, GlobalMed, to build a tele- cardiology system using GlobalMed's i8500 Series Mobile Video Cart. The wireless, telemedicine videoconferencing system includes EasyShare videoconferencing technology that uses the public Internet, enabling specialists to visit with patients on a virtual basis. It also includes a large, flat-panel touch screen PC for fast communications, as well as a high quality camera providing remote pan, tilt and optical zoom. Currently in the first phase of
  • 82. its tele-cardiology program, CQCH has connected its system and those of other, small Cochise County hospitals with the larger Tucson medical centers. From December 2009 to June 2010, 36 patients in the Emergency Department with suspected heart problems required cardiology consultation. Using the Mobile Telemedicine Cart equipped with a digital stethoscope, healthcare providers in Bisbee were able to provide cardiologists in Tucson with the ability to see and speak to the patients in real-time, hear their heart sounds clearly and review their electro-cardiograms via fax at the same time. These consultations confirmed that only nine of the 36 patients needed transport by ambulance or helicopter to another facility. The 27 patients who stayed in Bisbee were discharged from CQCH with prescriptions and/or heart monitors. The cost savings to patients and insurers was approximately $540,000 based on a $10,000 transfer cost and an additional $10,000 hospital stay per patient who instead had their care provided by CQCH and were able to remain in Bisbee. "The cost savings patients see as a result of the remote consultations is immense", said Dickson. "The cost for a helicopter transport is between $10,000 and $12,000. Additionally, the cost for treatment in a Tucson hospital is roughly $10,000 more per visit than it is here in Bisbee. So we're looking at a savings of about $20,000 per patient just by having the ability to consult with a specialist remotely, utilizing the telemedicine system, instead of having to be on-site where
  • 83. the doctor is. Results Dickson points to one case in particular as a perfect example of what tele-cardiology means to the town of Bisbee. An 81-year old man arrived at CQCH with apparent atrial fibrillation. A Tucson cardiologist saw the patient via video- conference, listened to his heart sounds and studied his EKG before determining that there was no need to move him to Tucson. The patient was admitted to CQCH, treated overnight and was discharged the next day with a halter monitor. In his case, the patient was spared an unnecessary transfer to a facility two hours away. He also avoided having to experience a lengthy hospital stay, as well as the hefty hospital bill for services that weren't needed. CQCH had similar success after partnering with Mayo Clinic Scottsdale for its tele-stroke program. More than three years ago, the Mayo Clinic started the Stroke Telemedicine Program for Arizona Rural Residents with a grant from the Arizona Department of Health Services. Medical studies have shown that stroke victims face a three-hour window in which the initiation of Tissue Plasminogen Activator, or TPA, can mean the difference between recovery and permanent paralysis. The phrase used in stroke programs is "Time is Brain." Jack Porter, the Mayor of Bisbee, can testify to TP A effectiveness. When Porter appeared to have suffered a stroke, he went to the CQCH. A telemedicine consultation with a Mayo neurologist in Scottsdale less than a half hour later
  • 84. confirmed the stroke diagnosis, and he ordered that Porter be started on a course of TPA. The timely treatment prevented any lasting debilitating effects, and Porter continues to lead the town as its mayor. When other rural hospitals in Cochise County recognized the advantages of telemedicine, they and CQCH formed the Southeast Arizona Telemedicine Association, or SATA, which includes the following hospitals: Northern Cochise Community Hospital in Willcox, Benson Community Hospital, Mount Graham Regional Medical Center in Safford and Southeast Arizona Medical Center in Douglas. Dickson says his hospital has not cut care in the wake of rising healthcare costs, but rather has increased it by making it more efficient. "By not having the transportation fees and the excessive cost of re-evaluation at another hospital, we have really spawned a cost reduction and quality increase in the delivery system," Dickson says. "Given our success with telemedicine at CQCH, I envision a virtual hospital in every rural area in America in the near future so that people will have the care they need and so that physician misdistribution becomes a problem of the past." CASE STUDY CHALLENGE: 1. Students should be asked to read the case and discuss all procedures done during this innovation Telemedicine Technique. 2. Remark, comment and evaluate the telemedicine videoconferencing system techniques.
  • 85. 3. Who Benefits from Telemedicine? 4. Will Patients Still Need to See a Specialist in Person? 5. In-person Doctor visit vs. Telemedicine visit, which is better? 3. Conclusion (15%) Briefly summarize your thoughts & conclusion to your critique for the case study. How did these articles and Chapters impact your thoughts on Telemedicine? Evaluation will be based on how clearly you respond to the above, in particular: a) The clarity with which you critique the chapters. b) The depth, scope, and organization of your paper; and, c) Your conclusions, including a description of the impact of these Chapters on any Healthcare Organization.