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 Component 1/Unit 6a2 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a3 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a4 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a5 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a6 Health IT Workforce Curriculum Version 1.0/Fall 2010

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. Component 1/Unit 6a7 Health IT Workforce Curriculum Version 1.0/Fall 2010

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. Component 1/Unit 6a8 Health IT Workforce Curriculum Version 1.0/Fall 2010

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. Component 1/Unit 6a9 Health IT Workforce Curriculum Version 1.0/Fall 2010

JCAHO (continued) Accreditation programs –Ambulatory Care –Behavioral Health Care –Critical Access Hospitals –Home Care –Hospitals –Laboratory Services –Long Term Care –Office-Based Surgery Component 1/Unit 6a10 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a11 Health IT Workforce Curriculum Version 1.0/Fall 2010

JCAHO (continued) Example of a standard Component 1/Unit 6a12 Health IT Workforce Curriculum Version 1.0/Fall 2010

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. Component 1/Unit 6a13 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a14 Health IT Workforce Curriculum Version 1.0/Fall 2010

JCAHO (continued) Certification Programs include Disease- specific 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 Component 1/Unit 6a15 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a16 Health IT Workforce Curriculum Version 1.0/Fall 2010

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. Component 1/Unit 6a17 Health IT Workforce Curriculum Version 1.0/Fall 2010

JCAHO (continued) Patient Safety Goals for Hospitals- continued –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. Component 1/Unit 6a18 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a19 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a20 Health IT Workforce Curriculum Version 1.0/Fall 2010

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. Component 1/Unit 6a21 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a22 Health IT Workforce Curriculum Version 1.0/Fall 2010

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. Component 1/Unit 6a23 Health IT Workforce Curriculum Version 1.0/Fall 2010

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. Component 1/Unit 6a24 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a25 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a26 Health IT Workforce Curriculum Version 1.0/Fall 2010

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 Component 1/Unit 6a27 Health IT Workforce Curriculum Version 1.0/Fall 2010

Other Regulatory Agencies (continued) FDA- –The FDA is responsible for the following areas 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) Component 1/Unit 6a28 Health IT Workforce Curriculum Version 1.0/Fall 2010

Other Regulatory Agencies (continued) FDA –FDA areas of responsibility, continued 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) Component 1/Unit 6a29 Health IT Workforce Curriculum Version 1.0/Fall 2010

Other Regulatory Agencies (continued) American Medical Association (AMA) –A professional organization that provides resources for physicians. Resources include 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 Component 1/Unit 6a30 Health IT Workforce Curriculum Version 1.0/Fall 2010

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. Component 1/Unit 6a31 Health IT Workforce Curriculum Version 1.0/Fall 2010