Chapter 11 Risk Management inSelected High-Risk Hospital Dep

Chapter 11: Risk Management in
Selected High-Risk Hospital Depts
High Risk Depts. in Hospitals
All clinical depts. in hospitals have potential for risk, but some
are greater than others:
Emergency Room
Obstetrics and Neonatology
Surgery and Anesthesia
Diagnostic Imaging
Treat highly vulnerable patients in often chaotic settings where
the results of errors can be catastrophic and costly
Emergency Medicine
Which Definition?
AMA – any condition clinically determined to require
immediate medical care
Federal Legislation – condition manifested by acute symptoms
of sufficient severity that the absence of immediate medical
attention could reasonably be expected to result in serious
jeopardy to an individual’s health, serious impairment to bodily
functions or serious dysfunction of any body organ or part
Clinicians –view emergencies as life-threatening situations
The mere existence of an ER implies a duty to treat any patient
who arrives
Emergency Medicine Issues
Emergency Medical Treatment and Active Labor Act

(EMTALA)
Pre-hospital services
Dept Capabilities and Staffing
Triage Process
Emergency Medicine Issues
Medical Records Documentation and Consent
Support Services
Departures, Discharges and Transfers
Risk Management
Lawsuits in this category are usually the most expensive
Advanced technology has improved survival rates for infants
but led to increased risks for facilities
Ethical Dilemmas
Standards and Guidelines
Levels of Care
Level 1 – least intensive and designed to treat low-risk mothers
and babies
Level 2 – must be able to manage high-risk mothers, high-risk
fetuses and small, sick neonates
Level 3 – must be able to monitor and maintain critical
functions of mothers and neonates the nurse to patient ratio is
more intensive as well

Prenatal and Perinatal Care
Intrapartum Period
Delivery
Neonatal Resuscitation and Management
Maternal Exam Post Delivery
Family Attendance Issues
Medical Record Documentation
Neonatal Services
Infant Transport
Infant Abduction
Surgery and Anesthesia claims are usually co-dependent
Increased number of surgeries performed in outpatient or
ambulatory settings with decrease in number of claims
Paid malpractice claims are higher in the outpatient setting
Handout Case Study
10
Negligence and Malpractice
Surgical Services Staff
Preoperative Assessment and Treatment
Intraoperative Risks
Postoperative Recovery
Documentation
Handout Case Study

11
Intraoperative Risks
Sedation and Anesthesia
Wrong Site, Wrong Procedure, Wrong Person
Implants
Retained Foreign Bodies
Patient Burns and Pressure Injuries
Surgical Fires
Handout Case Study
12
Diagnostic Imaging
Creating images of the human body utilizing various methods:
X-rays
Computed tomography (CT)
Interventional radiography
Ultrasound
Magnetic resonance imagine (MRI)
Positron emission tomography
Diagnostic Imaging
Malpractice allegations
Failure to diagnose
Misdiagnosis
Wrong diagnosis
Errors
Scanning -- Satisfaction of search
Recognition -- Visual perception
Decision making -- Influential perception

Diagnostic Imaging
Radiation exposure: GOAL - as low as reasonably achievable
Decrease time of exposure
Increase distance of the patient and staff from radiation source
Use proper shielding
Summary
These high-risk areas in the hospital should be carefully
reviewed for appropriate policies and procedures as well as
compliance with them
Communication and good customer service with patients is key
in these high-risk areas
Documentation is imperative in all areas but especially in high-
risk departments which tend to have a higher likelihood of
litigation
· (a) Identify overall corporate objectives of Groupon and
strategies implemented to achieve those objectives.
· (b.) Identify the strategic risks that potentially could impede
Groupon from achieving each objective.
Around one page.
Chapter 10: Strategies
to Reduce Liability
Managing Physicians

Facilities may have liability when a physician is involved in
malpractice
Respondeat superior
Ostensible agency
Corporate negligence
2
Professional Practice Acts
Regulatory boards
Created by State legislation
Statute defines the scope of professional practice and specifies:
Composition of the board
Duties and powers to create rules for the professional practice
Licensure process
Continuing education requirements
Investigation and disciplinary actions
Professional Discipline
Regulatory Board will:
Investigate suspected misconduct
Prosecute confirmed misconduct, as appropriate
Take appropriate disciplinary action for confirmed misconduct
License revocation
License suspension
Fines
Referrals for professional assistance
Examples of Misconduct

Repeated acts of negligence
Incompetence
Aiding or abetting the unlicensed practice of medicine
Failure to comply with government rules/regulations
Exploitation of the patient for financial gain
Evidence of moral unfitness to practice medicine
Examples of Misconduct
Failure to maintain appropriate medical records
Abandoning or neglecting a patient
Harassing, abusing, or intimidating a patients
Ordering excessive tests or treatments
Unlawful use of controlled substances
Physical impairment of professionals
Health problems, disease, disability, psychiatric issues, and
alcohol/chemical abuse
Symptoms of impairment
Making rounds late --complaints from staff
Inappropriate orders -- frequent accidents
Hostile behavior -- mood swings
Personal hygiene -- job changes
Neglected social commitments
Symptoms – p 243
7
Sexual Harassment
Providers are in the unique position of power
Patient is dependent on the provider

Identifying Previous Misconduct
Licensing boards share information concerning adverse actions
against providers across state lines
The Federation of State Medical Boards
National Practitioner Data Bank
Risk Managers should ensure that the facility hiring and
credentialing policies include a procedure for checking the data
banks
Designed to collect comprehensive data on adverse actions
taken against health care practitioners, malpractice payments
made and Medicare/Medicaid exclusions.
Insurance companies and hospitals are required to report to
DHHS and state licensing boards any medical malpractice
payments resulting from court judgments or settlements
Facilities are required to check the NPDB for all new medical
staff and every two years for re-credentialing
4 classes of adverse actions requiring reporting
Those taken against a practitioner’s license by a state medical
board
Those taken against a practitioner’s clinical privileges at a
health care facility
Those taken against membership by a professional society
Those taken by Medicare/Medicaid and the DEA
Clinical Practice Guidelines
Systematically developed statements to assist practitioners and
patient decisions about appropriate health care for specific

clinical circumstances.
Private Initiatives
Government Initiatives
Worker’s Compensation
Medical Liability Insurers
Risk managers must not only be aware of clinical practice
guidelines, but also the legal implications of ignoring them
Health professionals reviewing other like health professionals to
assess:
Quality concerns
Hospital privileging decisions
Group practice membership decisions
Staff conduct
Professional isolation
Education
Peer Review
Liability Alternatives
Limit number of lawsuits
Control size of awards
Limit access of plaintiffs to the system
Removal of Malpractice
Litigation from Judicial System
Several tort reform proposals recommend shifting malpractice
litigation away from the judicial system
Administrative Agencies
Alternative Dispute Resolution

No-Fault Proposals
Under this type of system, adverse outcomes would be
automatically compensated without lawsuits regardless of
whether the outcomes resulted from negligence.
Accelerated Compensation Events
Enterprise liability
Other methods
Summary
Risk Managers must work with the healthcare professionals in
terms of practice guidelines and peer review.
Proactive liability reduction can offer significant protection of
the organization’s financial resources.
Chapter 13: Risk Management in Psychiatry
Psychiatric Care
Healthcare and treatment of persons with acute and/or chronic
mental illness
Provided in various types of healthcare settings
Specialty facilities
Special unit in a hospital
Ambulatory centers
Private offices
Informed Consent
Psychiatric patients have the right to select their treatment (as
do all patient) unless deemed incompetent.
For the patient to be considered competent to consent to

treatment, they must be able to:
Communicate a choice
Understand information about the treatment
Recognize the clinical situation
Manipulate information rationally
Informed Consent and Research
Research guidelines must adhere to the general informed
consent requirements
The National Bioethics Advisory Commission issued a report
entitled “Ethical and Policy Issues in Research Involving
Human Participants” which outlines basic principles for
research studies
The Office for Human Research is another resource for
guidelines on obtaining consent, especially for children
Right to Treatment
Right to the Least Restrictive Alternative
Closure of Psychiatric Facilities
Involuntary Outpatient Treatment
Medical Necessity
Insurance Coverage
Psychiatric Advanced Directives (PAD)
Right to Refuse Treatment
All patients have the right to refuse treatment, even patients
with mental illness.
Psychotropic Medications
Involuntary Hospitalization
Involuntary Outpatient Treatment

Clinical Risks
Psychopharmacology and Side Effects
Electroconvulsive Therapy
Suicide
Discharge and Aftercare Planning
Seclusion and Restraint
Elopement and Wandering
Child and Adolescent Psychiatry
Confidentiality and Stigma
Public view of mental illness
Privileged Communication
Duty to Protect/Warn
High Risk Incidents
Violence and Mental Illness
Violence in the Institution
Availability of Illicit Substances
Professional Sexual Misconduct
Staff-Patient Sexual Misconduct
Other Areas of Concern
Fraud and Abuse
Public Safety
Noncompliance with treatment regimen
Summary

Patients with mental illness have the same rights as all patients
unless deemed incompetent.
There are additional risk management concerns involved in
treating patients with mental illness.
Chapter 12
Epidemiology of Infectious Diseases
Learning Objectives
State modes of infectious disease transmission
Define three categories of infectious disease agents
Identify the characteristics of agents
Define quantitative terms used in infectious disease outbreaks
Describe the procedure for investigating a disease outbreak
Infectious Diseases (Importance)
They are a significant cause of morbidity and mortality
worldwide.
Infectious agents are associated with some types of cancer.
Due to increasing world travel, infected passengers can transmit
the communicable disease from within the time span of a long-
distance plane flight.
They cause disease outbreaks in institutions.
Epidemiologic Triangle
A model used to explain the etiology of infectious diseases.
Recognizes three major factors in the pathogenesis of disease:
agent, host, and environment.

2
Diagram of Epidemiologic Triangle
Microbial Agents of Infectious Disease
Bacteria
Viruses
Rickettsia
Mycoses (fungal diseases)
Protozoa
Helminths
Arthropods
3
Bacteria
Once were the leading killers, but now are controlled by
antibiotics.
Remain significant causes of human illness.
Tuberculosis and salmonellosis are common diseases caused by
bacteria.

Emergence of antibiotic-resistant strains a growing concern.
Viruses
A microorganism composed of a piece of genetic material (RNA
or DNA) surrounded by a protein coat. To replicate, a virus
must infect a living cell.
Viral hepatitis A, herpes, and influenza are caused by viruses.
Rickettsia
A genus of bacteria that can grow within cells.
Ectoparasites (e.g., fleas, lice, and ticks) transmit the majority
of rickettsial agents, which cause a variety of diseases.
Rickettsial agents produce typhus fever,
Q fever and Rocky Mountain spotted fever.
Mycoses (Fungal Diseases)
Mycoses cause diseases such as coccidioidomycosis, ringworm,
and athlete’s foot.
Example of disease: A fall 2012 outbreak of fungal meningitis
was associated with a contaminated steroid medication and
associated with more than 400 cases and 30 deaths in at least 19
states.
Opportunistic mycoses infect immunocompromised patients.
Candidiasis, cryptococcosis, and aspergillosis.
4

Protozoa
Microscopic single-cell organisms.
Responsible for diseases, such as malaria, amebiasis,
babesiosis, cryptosporidiosis, and giardiasis.
Example: malaria is transmitted by mosquitos in endemic areas.
Helminths
Organisms found most frequently in moist, tropical areas.
Include intestinal parasites such as roundworms, pinworms, and
tapeworms.
Are responsible for trichinellosis and schistosomiasis.
Arthropods
Act as insect vectors that carry a disease agent from its
reservoir to humans.
Examples: mosquitos, ticks, flies, mites, and other insects.
Transmit diseases such as Dengue fever, Lyme disease, viral
encephalitis, Rocky Mountain spotted fever, trypanosomiasis,
and leishmaniasis.
5
Characteristics of Infectious Disease Agents
Infectivity

The capacity of an agent to enter and multiply in a susceptible
host and produce infection or disease.
Polio and measles are diseases of high infectivity.
Measured by the secondary attack rate.
6
Characteristics of Infectious Disease Agents
Pathogenicity
The capacity of the agent to cause overt disease in the infected
host.
Measles is a disease of high pathogenicity, whereas polio is a
disease of low pathogenicity.
Measured by the ratio of the number of individuals with
clinically apparent disease to the number exposed to an
infection.
6
Characteristics of Infectious Disease Agents (cont’d)
Virulence
Refers to an agent’s capacity to induce disease in the host.

Sometimes used as a synonym for pathogenicity.
Measured by the ratio formed by the number of total cases with
overt infection divided by the total number of infected cases.
If fatal, use case fatality rate (CFR).
7
Toxigenicity
Refers to the capacity of the agent to produce a toxin or poison.
The pathologic effects of agents for diseases such as botulism
and shellfish poisoning result from the toxin produced by the
microorganism rather than from the microorganism itself.
7
Resistance
The ability of the agent to survive adverse environmental
conditions.
Antigenicity
The ability of the agent to induce antibody production in the

host. Related to immunogenicity.
8
Host: Definition
(Refer to Glossary)
A person (or animal) who permits lodgment of an infectious
disease agent under natural conditions.
Host
Once an agent infects the host, the degree and severity of the
infection will depend on the host’s ability to fight off the
infectious agent.
Two types of defense mechanisms are present in the host:
nonspecific and disease-specific.
9
Nonspecific Defense Mechanisms
Examples include skin, mucosal surfaces, tears, saliva, gastric
juices, and the immune system.

Host responses to infectious agents
immunity may decrease as we age.
nutritional status of the host
Genetic factors
10
Disease-Specific Defense Mechanisms
Immunity (resistance) of the host to a disease agent.
Types of immunity:
Active: A disease organism stimulates the potential host’s
immune system to create antibodies against the disease. Long
lasting, but requires time to develop.
Passive: short-term immunity provided by a preformed
antibody.
11
Active Immunity
Natural, active or natural immunity
Results from an infection by the agent.
Example: A patient develops long-term immunity to measles

because of a naturally acquired infection.
Artificial, active or vaccine-induced immunity
Results from an injection with a vaccine that stimulates
antibody production in the host.
12
Passive Immunity
Natural, passive--preformed antibodies are passed to the fetus
during pregnancy and provide short-term immunity in the
newborn.
Artificial, passive
Preformed antibodies are given to exposed individuals to confer
protection against a disease.
Example: Prophylaxis against hepatitis by administration of
immune globulin to individuals who have been exposed.
Environment
The domain external to the host in which the agent may exist,
survive, or originate.
The environment consists of physical, climatologic, biologic,
social, and economic components that affect the survival of the
agents and serve to bring the agent and host into contact.
13

Reservoirs of Infectious Diseases
The environment can act as a reservoir that fosters the survival
of infectious agents.
Examples: contaminated water supplies or food; soils;
vertebrate animals.
14
Animal Reservoirs
Animals can be reservoirs of infectious agents.
Zoonoses--infectious diseases that are potentially transmittable
to humans by vertebrate animals. Examples: rabies and the
plague.
Direct Transmission from Reservoir
Spread of infection through person-to-person contact.
Example
Direct contact with the blood or bodily fluids of an infected
person as in the spread of sexually transmitted diseases.
15

Indirect Transmission from Reservoir
Spread of infection through an intermediary source: vehicles,
fomites, or vectors.
Examples of vehicles - Contaminated water, infected blood on
used hypodermic needles, and food.
Examples of fomites – Inanimate objects, such as a doorknob or
clothing – laden with disease-causing agents.
Examples of vectors – flies and mosquitos
15
Portals of Exit and Entry
Portal of exit—sites where infectious agent may leave the body,
e.g., respiratory passages, the alimentary canal, and the
openings in the genitourinary system, and skin lesions.
Agent must exit in large enough quantities to survive in the
environment and overcome the defenses at the portal of entry
into the host.
Portal of entry--locus of access to the human body, e.g., mouth
and digestive system and the mucous membranes or wounds in
the skin.

Inapparent Infection
A subclinical infection that has not yet penetrated the clinical
horizon--No symptoms of infection present.
Important because disease can be transmitted to unsuspecting
hosts.
In asymptomatic individuals, clinicians can look for serologic
evidence of infection.
Example: Increase in antibodies and enzymes in patients with
hepatitis A virus.
16
Incubation Period
The time interval between exposure to an infectious agent and
the appearance of the first signs and symptoms of disease.
Applies only to clinically apparent cases of disease.
Provides a clue to the time and circumstance of exposure to the
agent.
Useful for determining the etiologic agent.
17

Herd Immunity
Immunity of a population, group, or community against an
infectious disease when a large proportion of individuals are
immune either through vaccinations or prior infection.
18
Generation Time
Time interval between lodgment of an infectious agent in a host
and the maximal communicability of the host.
Can precede the development of active symptoms.
Useful for describing the spread of infectious agents that have
large proportions of subclinical cases.
Applies to both inapparent and apparent cases of disease.
19
Colonization and Infestation
Colonization--agents multiply on the surface of the body
without invoking tissue or immune response.
Infestation--the presence of a living infectious agent on the
body’s exterior surface, upon which a local reaction may be

invoked.
20
Iceberg Concept of Infection
The tip of the iceberg, which corresponds to active clinical
disease accounts for only a small proportion of host’s infections
and exposures to disease agents.
21
Iceberg Concept (cont’d)
Measures of Disease Outbreaks
Attack rate
Secondary attack rate
Case fatality rate

23
Attack Rate
The proportion of a group that experiences the outcome under
study over a given period.
Similar to an incidence rate.
Used when the occurrence of disease among a population at risk
increases greatly over a short period of time.
Formula: Ill X 100 during a time period
Ill + Well
24
Secondary Attack Rate
An index of the spread of disease in a family, household,
dwelling unit, dormitory or similar circumscribed group.
A measure of contagiousness.
Useful in evaluating control measures.
25

Secondary Attack Rate: Definition
The number of cases of infection that occur among contacts
within the incubation period following exposure to a primary
case in relation to the total number of exposed contacts.
Number of new cases in group - initial case(s) Number of
susceptible persons in the group -
initial case(s)
Initial case(s) = Index case(s) + coprimaries
Index case(s) = Case that first comes to the attention of public
health authorities.
Coprimaries = Cases related to index case so closely in time
that they are considered to belong to the same generation of
cases.
Secondary Attack Rate (%) (Multiply fraction by 100.)
26
Case Fatality Rate (CFR)
Proportion formed by the number of deaths caused by a disease
among those who have the disease during a time interval.
Provides an index of the virulence of a particular disease within
a specific population.

Examples of diseases with a high CFR are rabies and untreated
bubonic plague.
27
Formula for CFR
Number of deaths due to disease “X” x 100 Number
of cases of disease “X”
Sample calculation: Assume that an outbreak of plague occurs
in an Asian country during the month of January. Health
authorities record 98 case of the disease, all of whom are
untreated. Among these, 60 deaths are reported.
CFR = (60/98) x 100 = 61.2%
28
Basic Reproductive Rate (R0)
A measure of the number of infections produced on average by
an infected individual in the early stages of an epidemic when
virtually all contacts are susceptible.
Can be used as a measure of the transmissibility of influenza.

Investigation of Infectious Disease Outbreaks
Define the problem.
Appraise existing data.
Case identification
Clinical observations
Tabulation and spot maps
Identification of responsible agent
29
Investigation (cont’d)
Formulate a hypothesis.
Test the hypothesis.
Draw conclusions and formulate practical applications.
Epidemiologically Significant Categories of Infectious Diseases
Foodborne illness
Water- and foodborne diseases
Sexually transmitted diseases
Vaccine-preventable diseases
Diseases spread by person-to-person contact
Zoonotic diseases
Fungal diseases (mycoses)
Arthropod-borne diseases

30
Foodborne Illness
One of the most common infectious disease problems in the
community.
Examples include:
Staphylococcus aureus--present in contaminated food that have
been stored at improper temperatures.
Trichinosis--associated with inadequately cooked pork products.
31
Foodborne Agents
Water- and Foodborne Diseases
Examples include:
Amebiasis--intestinal disease.
Cholera--acute enteric disease.

Giardiasis
Legionellosis
Schistosomiasis--infection caused by adult worms in the
bloodstream. The cycle involves alternate human and snail
hosts.
32
Sexually Transmitted Diseases: HIV/AIDS
High-risk populations in the U.S.
Men who has sex with men (MSM)
African Americans, Hispanics or Latinos
Injection drug use
In 2008, the estimated prevalence of AIDS diagnoses in the
general U.S. population was 157.7 per 100,000 population.
The human immunodeficiency virus (HIV) is an acute problem
worldwide.
Approximately 34.2 million people were living with HIV in
2011.
33

Vaccine-Preventable Diseases
Vaccines are routinely given to children (0-6 years) for the
prevention of several diseases, including:
Chickenpox, Diphtheria, Haemophilus influenzae type b
infections, hepatitis A, hepatitis B, influenza, measles,
meningococcal meningitis, mumps, pertussis, paralytic
poliomyelitis, pneumococcal disease, rotaviral enteritis, rubella,
and tetanus.
34
Diseases Spread by Person-to-Person Contact
One example is tuberculosis.
Resurgence of TB (from late 1980s until mid-1990s) due to:
Increase in persons infected with HIV.
Increase in homeless population.
Importation of cases from endemic areas.
35

U.S. TB Cases, 1980-1992
Source: Reprinted from Centers for Disease Control and
Prevention. Tuberculosis morbidity—United States, 1992.
MMWR, vol 42, p 696, September 17, 1993.
U.S. TB Cases
By 2010, TB incidence had declined.
Most affected groups were foreign-born individuals and racial
and ethnic minorities.
Current high-risk populations
Migrant farm workers
Homeless persons
Extensively drug-resistant tuberculosis (XDR TB) was the focus
of media attention in 2007.
Zoonotic Diseases
Zoonosis--a disease that under natural conditions can be spread
from vertebrate animals to humans.
Examples: Anthrax, brucellosis, leptospirosis, Q fever, and
rabies.
Zoonotic diseases may be either:
Enzootic--similar to endemic in human diseases.
Epizootic--similar to epidemic in human diseases.
36

Fungal Diseases (Mycoses)
Three major types:
Opportunistic infections among persons who have weakened
immune systems
Hospital-associated and Community-acquired infections
Coccidioidomycosis (San Joaquin Valley fever )
Manifests as a lung disease and is caused by the fungus
Coccidioides immitis.
Cases of infection usually have had contact with contaminated
soil.
Arthropod-Borne Diseases
Include arboviral diseases.
Blood-feeding arthropod vectors transmit disease agents to
vertebrate hosts.
Examples of vectors: sand flies, ticks, mosquitoes.
Examples of diseases: Dengue fever, Lyme disease, malaria,
viral encephalitis, West Nile Virus, and plague
Emerging Infections
Infectious disease that have recently been identified and
taxonomically classified.
Refers to certain ‘old’ diseases that have experienced a
resurgence because of a changed host-agent-environment
conditions.
Examples: HIV/AIDS, hepatitis C virus infections, Lyme
disease, E.coli O157:H7 foodborne illnesses, and hantavirus
pulmonary syndrome.
Emerging Infectious Diseases

HAS-6505 Health Care Risk Management: Assignment Week 5
Organizational Analysis Strategies: Chapters 10 to 13
Objective: In this assignment you are request to organize and
present a virtuous cluster of strategies that will be use in the
High-Risk Hospital Department of your choosing to reduce
liabilities and improve the risks management plans and tactics
that help to provide safe and effective patient care that applies
to all departments.
ASSIGNMENT GUIDELINES (10%):
Students will judgmentally evaluate the readings from Chapter
10 to 13 on your textbook assigned for week 5. The Purpose of
this Organizational analysis is to create and produce a group of
the strategies that help to reduce liabilities in High-Risk
Hospital Department. You need to choose a Hospital department
(Emergency, Obstetrics, Neonatology, Surgery, etc.) And
develop a 4-5-page paper long including title page and
references page reproducing your understanding and capability
to relate the readings to your Hospital High-Risk Department.
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 you read, in your own
words.
2. Your Strategies (50%)
a. Clarify the role and scope of care provide by this Hospital
department.
b. Discussion and define the possible risk and when the greatest
risks can occur in this department.
c. Present the clusters of strategies for each of the risks you

reference before.
3. Conclusion (15%)
Briefly summarize your thoughts & conclusion to this
assignment and your appraisal of the Chapter you read. How
did these Chapters impact your thoughts about strategies to
prevent liability? How this Organization Analysis help you in
relation to
Evaluation will be based on how clearly you respond to the
above, in particular:
a) The clarity with which you present and analyzed the
strategies;
b) The depth, scope, and organization of your Organizational
Analysis paper; and,
c) Your conclusions, including a description of the impact of
these Chapters on any Healthcare Organization.
Chapter 11
Screening for Disease in the Community
Learning Objectives
Define and discuss reliability and validity, giving
differentiating characteristics and interrelationships
Identify sources of unreliability and invalidity of measurement
Define the term screening and list desirable qualities of
screening tests
Learning Objectives
(Cont’d)
Define and discuss sensitivity and specificity, giving
appropriate formulas and calculations for a sample problem
Identify a classification system for a disease

Screening for Disease
Screening--the presumptive identification of unrecognized
disease or defects by the application of tests, examinations, or
other procedures that can be applied rapidly.
Positive screening results are followed by diagnostic tests to
confirm actual disease.
Example: phenylalanine loading test in children positive on
PKU screening
Multiphasic Screening
Defined as the use of two or more screening tests together
among large groups of people.
Information obtained on risk factor status, history of illness,
and physiologic and health measurements.
Commonly used by employers and health maintenance
organizations.
Mass Screening and
Selective Screening
Mass screening--screening on a large scale of total population
groups regardless of risk status.
Selective screening--screens subsets of the population at high
risk for disease.
More economical, and likely to yield more true cases.
Example: Screening high-risk persons for Tay-Sachs disease.

Mass Health Examinations
Population or epidemiologic surveys--purpose is to gain
knowledge regarding the distribution and determinants of
diseases in selected populations.
No benefit to the participant is implied.
Mass Health Examinations (cont’d)
Epidemiologic surveillance--aims at the protection of
community health through case detection and intervention (e.g.,
tuberculosis control).
Case finding (opportunistic screening)--the utilization of
screening tests for detection of conditions unrelated to the
patient’s chief complaint.
Appropriate Situations for Screening Tests and Programs
Social
Scientific
Ethical
Social
The health problem should be important for the individual and
the community.
Diagnostic follow-up and intervention should be available to all
who require them.
There should be a favorable cost-benefit ratio.

Public acceptance must be high.
Scientific
Natural history of the condition should be adequately
understood.
This knowledge permits identification of early stages of disease
and appropriate biologic markers of progression.
A knowledge base exists for the efficacy of prevention and the
occurrence of side effects.
Prevalence of the disease or condition is high.
Ethical
The program can alter the natural history of the condition in a
significant proportion of those screened.
Suitable, acceptable tests for screening and diagnosis of the
condition as well as acceptable, effective methods of prevention
are available.
Characteristics of a Good Screening Test
Simple--easy to learn and perform.
Rapid--quick to administer; results available rapidly.
Inexpensive--good cost-benefit ratio.
Safe--no harm to participants.
Acceptable--to target group.

Evaluation of Screening Tests
Reliability types
Repeated measurements
Internal consistency
Interjudge
Validity types
Content
Criterion-referenced
Predictive
Concurrent
Construct
Reliability (Precision)
The ability of a measuring instrument to give consistent results
on repeated trials.
Repeated measurement reliability--the degree of consistency
among repeated measurements of the same individual on more
than one occasion.
Reliability (cont’d)
Internal consistency reliability--evaluates the degree of
agreement or homogeneity within a questionnaire measure of an
attitude, personal characteristic, or psychological attribute.
Interjudge reliability--reliability assessments derived from
agreement among trained experts.

Validity (Accuracy)
The ability of a measuring instrument to give a true measure.
Can be evaluated only if an accepted and independent method
for confirming the test measurement exists.
Validity (cont’d)
Content validity--the degree to which the measurement
incorporates the domain of the phenomenon under study.
Criterion-referenced validity--found by correlating a measure
with an external criterion of the entity being assessed.
Validity (cont’d)
Two types of criterion-referenced validity:
Predictive validity--denotes the ability of a measure to predict
some attribute or characteristic in the future.
Concurrent validity--obtained by correlating a measure with an
alternative measure of the same phenomenon taken at the same
point in time.
Validity (cont’d)
Construct Validity--degree to which the measurement agrees
with the theoretical concept being investigated.
Interrelationships Between Reliability and Validity

It is possible for a measure to be highly reliable but invalid.
It is not possible for a measure to be valid but unreliable.
Representation of Reliability and Validity
Sources of Unreliability and Invalidity
Measurement bias--constant errors that are introduced by a
faulty measuring device and tend to reduce the reliability of
measurements.
Example: A miscalibrated blood pressure manometer.
Sources of Unreliability and Invalidity (cont’d)
Halo effect—the influence upon an observation of the
observer’s perception of the characteristics of the individual
observed. The influence of the observer’s recollection or
knowledge of findings on a previous occasion.
Example: a health care provider’s tendency to rate a patient’s
sexual behavior use in a particular manner, based on a general
opinion about a patient’s characteristics without obtaining
specific information about past sexual behavior.
Sources of Unreliability and Invalidity (cont’d)
Social desirability effects - - Respondent answers questions in a
manner that agrees with desirable social norms.
Example: Teenage boys might respond to a screening interview

about sexual behavior by exaggerating their frequency of sexual
activities because these behaviors might be perceived as
socially desirable among some male peer groups.
Fourfold (2 by 2)Table
Measures of the Validity of Screening Tests
Sensitivity--the ability of the test to identify correctly all
screened individuals who actually have the disease (a/a+c).
Specificity--the ability of the test to identify only nondiseased
individuals who actually do not have the disease (d/b+d).
Measures of the Validity of Screening Tests (cont’d)
Predictive value (+)--the proportion of individuals screened
positive by the test who actually have the disease (a/a+b).
Predictive value (-)--the proportion of individuals screened
negative by the test who do not have the disease (d/c+d).
Other Measures from the
Fourfold (2 by 2) Table
Accuracy of a screening test
determined by the following formula:
(a+d)/(a+b+c+d).
Prevalence

determined by the formula:
(a+c)/(a+b+c+d)
Sample Calculation
Effects of Disease Prevalence on the Predictive Val ue of a
Screening Test
When the prevalence of a disease falls, the predictive value (+)
falls, and the predictive value (-) rises.
Exhibit 11-4
Illustrates the importance of positive predictive value in the
prostate cancer screening controversy.
PSA routine screening was widespread in the U.S. by 1991.
The U.S. Preventive Services Task Force calculated that the
harms of PSA screening outweigh the benefits.
Relationship Between Sensitivity and Specificity
To improve sensitivity, the cut point used to classify individuals
as diseased should be moved farther in the range of the
nondiseased (normals).
To improve specificity, the cut point should be moved farther in
the range typically associated with the disease.
Relationship Between Sensitivity and Specificity (cont’d)

Procedures to Improve Sensitivity and Specificity
Retrain screeners--reduces the amount of misclassification in
tests that require human assessment.
Recalibrate screening instrument--reduces the amount of
imprecision.
Utilize a different test.
Utilize more than one test.
Evaluation of Screening Programs
Randomized control trials
Subjects randomly receive either the new screening test or usual
care.
Ecologic time trend studies
Compare geographic regions with screening programs to those
without.
Case-control studies
Cases--fatal cases of the disease.
Controls--nonfatal cases.
Exposure--screening program.
Sources of Bias in Screening
Lead time bias
The perception that the screen-detected case has longer survival
because the disease was identified early.
Length bias
Particularly relevant to cancer screening.

Tumors identified by screening are slower growing and have a
better prognosis.
Selection bias
Motivated participants have a different probability of disease
than do those who refuse to participate.
Natural History of Disease
Issues in the Classification of Morbidity and Mortality
The nomenclature and classification of disease are central to the
reliable measurement of the outcome variable in epidemiologic
research.
Nomenclature--a highly specific set of terms for describing and
recording clinical or pathologic diagnoses to classify ill persons
into groups.
Issues in the Classification of Morbidity and Mortality (cont’d)
Classification--the statistical compilation of groups of cases of
disease by arranging disease entities into categories that share
similar features.
Two types of criteria used for the classification of ill persons:
Causal (e.g., tuberculosis or syphilis)
Manifestational (e.g., affected anatomic site: hepatitis or breast
cancer)
HSA-6520 Managerial Epidemiology: Week 5

Epidemiology: Chapters 11 and 12.
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 hearten 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 you’re
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 Chapter you read. How did these 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 chapters;
b) The profundity, choice, and association of your paper; and,
c) Your conclusions, including a description of the impact of
these Chapters on any Health Care Setting.

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