Transcript Component 1: Introduction to Health Care and Public Health in the US

Component 1: Introduction
to Health Care and Public
Health in the US
Unit 6- Regulating Health Care
Lecture a- Regulatory Agencies—
JCAHO, FDA, AMA, & AHA
Regulating Health Care
Objectives
• Describe the role of JCAHO and the
process of accreditation and certification of
health care organizations in the US
• Identify the major health care regulatory
bodies in the US
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The Joint Commission for the
Accreditation of Health Care
Organizations (JCAHO)
• The Joint Commission for the Accreditation of Health
Care Organizations (JCAHO)
– An independent, not-for-profit organization
– Accredits and certifies >18,000 organizations in US
– JCAHO accreditation and certification is a symbol of
quality and meeting standards
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JCAHO (continued)
• History
– Started in 1910 as the American College of
Surgeons (ACS)
– 1917- ACS developed the minimum standards
for hospitals
– 1951- The Joint Commission for the
Accreditation of Hospitals by the American
College of Physicians, American Hospital
Association, American Medical Association,
and the Canadian Medical Association
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JCAHO (continued)
• History (continued)
– 1951- First director was Edwin L. Crosby, MD
– 1959- Canadian Medical Association withdrew
to develop its own system
– 1965- Congress passed Social Security Act
and linked JCAH accreditation to compliance
with Medicare conditions for participation
– 1993- JCAH became JCAHO
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JCAHO (continued)
• Mission
– To continuously improve health care for the public, in
collaboration with other stakeholders, by evaluating
health care organizations and inspiring them to excel
in providing safe and effective care of the highest
quality and value.
• Vision
– All people always experience the safest, highest
quality, best-value health care across all settings
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JCAHO (continued)
• The Joint Commission is governed by a
29-member Board of Commissioners that
includes physicians, administrators,
nurses, employers, a labor representative,
health plan leaders, quality experts,
ethicists, a consumer advocate and
educators.
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JCAHO (continued)
• How does JCAHO accomplish its mission?
• Accreditation can be earned by an entire health
care organization, for example, hospitals, nursing
homes, office-based surgery practices, home care
providers, and laboratories.
• In addition to submitting written documents that
demonstrate compliance with the standards, a site
visit is also required to verify improvement
activities.
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JCAHO (continued)
• Certification is earned by programs or
services that may be based within or
associated with a health care organization.
For example, a Joint Commission
accredited medical center can have Joint
Commission certified programs or services
for diabetes or heart disease care. These
programs could be within the medical
center or in the community.
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JCAHO (continued)
• Accreditation programs
– Ambulatory Care
– Behavioral Health Care
– Critical Access Hospitals
– Home Care
– Hospitals
– Laboratory Services
– Long Term Care
– Office-Based Surgery
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JCAHO (continued)
• Accreditation Process Overview
– Example- hospitals: areas in the manual
• Emergency Management; Environment of Care;
Human Resources; Infection Prevention and
Control; Information Management; Leadership; Life
Safety; Medical Staff; Medication Management;
National Patient Safety Goals; Performance
Improvement; Provision of Care, Treatment, and
Services; Record of Care, Treatment, and
Services; Rights and Responsibilities of the
Individual; Waived Testing
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JCAHO (continued)
• Example of a standard
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JCAHO (continued)
• Surveys
– This is individualized to each organization.
JCAHO evaluates an organization’s
performance functions and processes aimed
at continuously improving patient outcomes.
– The surveys are unannounced—the health
care organizations does not know that the
“inspectors” are coming.
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JCAHO (continued)
• Compliance with the standards is scored
determining compliance with the elements
of performance.
• Accreditation decisions include
Accreditation, Provisional accreditation,
Conditional accreditation, Preliminary
denial of accreditation, denial of
accreditation, and preliminary
accreditation
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JCAHO (continued)
• Certification Programs include Diseasespecific care certification, Health care staffing
certification, Joint commission certification,
and Primary stroke center certification.
• Advanced certification programs include
Chronic kidney disease, Chronic obstructive
pulmonary disease, Heart failure, Inpatient
diabetes, Lung volume education surgery,
Primary stroke centers, Ventricular assist
device
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JCAHO (continued)
• Patient Safety
– In 2002, JCAHO introduced National Patient
Safety Goals.
– Promote specific improvements in patient
safety
– Highlight problematic areas
– Focus on system-wide improvements
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JCAHO (continued)
• Patient Safety Goals for Hospitals
– Improve the accuracy of patient identification.
– Improve the effectiveness of communication
among caregivers.
– Improve the safety of using medications.
– Reduce the risk of health care–associated
infections.
– Accurately and completely reconcile
medications across the continuum of care.
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JCAHO (continued)
• Patient Safety Goals for Hospitalscontinued
– Reduce the risk of patient harm resulting from
falls.
– Prevent health care–associated pressure
ulcers (decubitus ulcers).
– The organization identifies safety risks
inherent in its patient population.
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JCAHO (continued)
• No adverse event should occur if knowledge
exists to prevent it from happening.
• Patient Safety Solutions– Guide re-design of care processes to prevent
errors
– Each solution• Presents the problem, strength of evidence supporting
the solution, potential barriers to adaption, risks of
unintended consequences, patient and family roles,
and references
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JCAHO (continued)
• JCAHO’s commitment to patient safety
– 50% of accreditation standards related to
patient safety
– Include specific requirements for the response
to adverse events
– Prevention of accidental harm through
analysis and redesign of systems
– The organization’s responsibility to tell a
patient about outcomes—good or bad
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JCAHO (continued)
• In 2003, develop Universal Protocol
– This protocol is for preventing wrong site,
wrong procedure, and wrong person surgery.
• Office of Quality Monitoring
– Purpose- evaluates complaints and reports of
concerns about health care organizations
relating to quality of care issues.
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JCAHO (continued)
• JCAHO has a Division of Quality
Measurement and Research.
– Purpose- address patient safety research from a
variety of perspectives and works with external
collaborators to advance the field.
• JCAHO also uses their Speak Up ™
program to educate patients about many
safety issues
– i.e. Surgical mistakes, living organ donations,
infection prevention, medication mistakes, etc
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JCAHO (continued)
• JCAHO also work with many other health
care and patient safety advocates and with
Congressional Committees to pass
legislation related to patient safety.
• In1996, JCAHO implemented its Sentinel
Event Policy.
– Health care organizations identified Sentinel
Events and took action to prevent its
recurrence.
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JCAHO (continued)
• Sentinel Event- an unexpected death or
serious physical—including loss of limb or
function—or psychological injury, or risk
thereof.
• Risk thereof means that although no harm
occurred this time, any recurrence carry
the risk of a serious adverse outcome.
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JCAHO (continued)
• Performance Management
– Continuous quality improvement is at the heart of
JCAHO’s accreditation process and standards.
– JACHO mandates health care organizations utilize
performance measurement systems to continuously
evaluated processed and procedures as well as
continuously improve them.
– ORYX ® is a performance management system that
creates a more continuous, data-driven,
comprehensive, and valuable accreditation process
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JCAHO (continued)
• JCAHO is also involved in Public Policy
Initiatives, for example
– Guiding principles for the Development of the
Hospital of the Future
– Development of a National Performance
Measurement Data Strategy
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Other Regulatory Agencies
• Other Regulatory Agencies include FDA,
AHA, and AMA
– FDA- Food and Drug Administration
• Part of the Department of Health and Human
Services
• Performs drug approvals
• Provides drug safety information
• Spreads the message about medication error
through public health advisories, medication
guides, and outreach programs
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Other Regulatory Agencies
(continued)
• FDA– The FDA is responsible for the following areas
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Allergenics
Blood and Blood Products
Cellular and Gene Therapy Products
Tissue and Tissue Products
Vaccines
Xenotransplantation
Development and Approval Process (Biologics)
Guidance, Compliance, and Regulatory Information
(Biologics)
• Safety and Availability (Biologics)
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Other Regulatory Agencies
(continued)
• FDA
– FDA areas of responsibility, continued
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Science and Research (Biologics)
Resources for You (Biologics)
Products and Medical Procedures
Medical Device Safety
Device Advice: Device Regulation and Guidance
Science and Research (Medical Devices)
Resources for You (Medical Devices)
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Other Regulatory Agencies
(continued)
• American Medical Association (AMA)
– A professional organization that provides
resources for physicians. Resources include
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Solutions for Managing Your Practice
Clinical Practice Improvement
Continuing Medical Education
Medical Ethics (Subcommittee)
Medical Science (updates)
Public Health (updates)
Physician Health
Patient Education Materials
Legal Issues
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Other Regulatory Agencies
(continued)
• American Hospital Association
– The voice of hospitals and health systems in
Washington, earning respect and attention
from political and opinion leaders. AHA has a
strong record of changing the thinking of
Congress and the executive branch
– Goal- make federal policy-making relevant to
the real work of taking care of people and
keeping them well.
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