Component 1 Unit 6 Lecture a Regulatory Agencies JCAHO, FDA, and AMA

Component 1 unit 6 lecture a—Regulatory Agencies—JCAHO, FDA, and AMA

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

•Describe the key processes in regulating the confidentiality and safety of the patient in the healthcare environment

The Joint Commission for the Accreditation of Health Care Organizations (JCAHO). This organization is an independent, not-for-profit organization that accredits and certifies >18,000 organizations in the US. JCAHO accreditation is a symbol of quality and meeting rigorous standards. The federal government recognizes JCAHO as an organization that promotes quality improvement in health care organizations.

Let’s take a look at the history of JCAHO. The American College of Surgeons (ACS) was the precursor of JCAHO. Up to this point, hospitals were considered almshouses and were used to care for the poor with no family to care for them. One of the founding surgeons of the ACS proposed the “end result system of hospital standardization.” (JCAHO website) This system proposed that a patient remain in a hospital under treatment until it could be determined whether the treatment was effective. If the treatment did not work, the hospital would figure out why it did not work and change the treatment for the next patient.

In 1917, ACS developed minimum standards for hospitals.

By 1951, The ACS joined with the American Hospital Association (AHA) , the American Medical Association (AMA), and the Canadian Medical Association (CMA) to form The Joint Commission for the Accreditation of Hospitals (JCAH). JCAH was a non-profit organization who mission was to accredit hospitals.

1951- The first director of JCAH was Edwin L. Crosby, MD

In 1959, The Canadian Medical Association withdrew from JCAH to form its own accrediting body in Canada.

In 1965, Congress passed the Social Security Act enacting Medicare. This legislation also contained a provision that if a hospital had earned JCAH accreditation that the hospital was “deemed” to be in compliance with most of the Medicare Conditions to Participate.

In 1993, JCAH became JCAHO—Joint Commission on the Accreditation of Healthcare Organizations

The Mission of JCAHO is “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.”

The Vision of JCAHO is “All people always experience the safest, highest quality, best-value health care across all settings.

The JCAHO 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. The Board of Commissioners brings to The Joint Commission diverse experience in health care, business and public policy. The Joint Commission employs approximately 1,000 people in its surveyor force, at its central office in Oakbrook Terrace, Illinois, and at a satellite office in Washington, D.C. The Washington office is The Joint Commission’s primary interface with government agencies and with Congress, seeking and maintaining partnerships with the government that will improve the quality of health care for all Americans, and working with Congress on legislation involving the quality and safety of health care.

JCAHO accomplishes its mission through granting accreditation and certification to health care organizations that meet or exceed its standards. 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. Joint Commission standards address the organization’s level of performance in key functional areas, such as patient rights, patient treatment, medication safety and infection control. The standards focus on setting expectations for an organization’s actual performance and for assessing its ability to provide safe, high quality care. Standards set forth performance expectations for activities that affect the safety and quality of patient care. If an organization does the right things and does them well, there is a strong likelihood that its patients will experience good outcomes. The Joint Commission develops its standards in consultation with health care experts, providers, measurement experts, purchasers, and consumers.

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.

The Joint Commission’s accreditation process seeks to help organizations identify and resolve problems and to inspire them to improve the safety and quality of care and services provided. The process focuses on systems critical to the safety and the quality of care, treatment and services. The present accreditation programs offered by JCAHO include ambulatory care, behavioral health care, critical access hospitals, home care, hospitals, laboratory services, long term care and office-based surgery.

JCAHO puts forth accreditation standards for the organizations it accredits in manual. This manual contains the standards and scoring matrix for each standard. Every type of organization accredited by JCAHO has a manual that is customized to fit the scope of services offered by the organization. The manuals for hospitals are quite large and contain the following areas: 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

This slide contains a screen shot of a page containing a standard and elements of performance in a JCAHO manual.

The survey process at JCAHO is a synonym for the accreditation process. Every survey is tailored to the individual organization for consistency and to enhance the organization’s quality improvement processes. The main goal of the accreditation process is continuous quality improvement of an organization’s functions and processes. An organization’s compliance with the accreditation standards in the manual is based on the care the organization delivers to patients, verbal and written materials provided to JCAHO, and on-site interviews and observations. This accreditation process is very similar to accreditation processes that occur in education and other health care fields. JCAHO visits are unannounced and can occur 18 to 39 months after completion of a full survey visit. An organization is evaluated on how well they comply with the standards, based on the elements of performance. The elements of performance are specific performance targets that must be met to ensure that an organization provides safe, high quality care, treatment, and service to patients.

Once the data is collected by the on-site survey team, an exit conference for the organization is scheduled. At this organizational conference, the survey team presents a preliminary Summary of Survey Findings report. This report usually contains commendations, or preliminary findings by the on-site team. The team will formalize the report and submit the Evidence of Standards Compliance submission to the Board for approval. The Board makes the accreditation decisions in the following categories: accreditation, provisional accreditation, conditional accreditation, preliminary denial of accreditation, denial of accreditation, and preliminary accreditation.

In addition to full accreditation, JCAHO also has certification and advanced certification programs. 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

In 2002, JCAHO introduced National Patient Safety Goals. The purpose of the Joint Commission’s National Patient Safety Goals is to promote specific improvements in patient safety. The goals were in response to the Institute of Medicine’s landmark report, “To Err is Human”, released in 2000 and highlighted the problem of medical errors in the US health care system. The goals address problematic areas in health care and describe evident-based solutions to the problems. Consistent with the Institute of Medicine’s report, these safety goals focus on system-wide improvements.

Along with the JCAHO standards, accredited health care organizations are also evaluated for continuous compliance with the National Patient Safety Goals. The patient safety goals for hospitals include 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, and accurately and completely reconcile medications across the continuum of care.

More patient safety goals for hospitals include reduce the risk of patient harm resulting from falls, prevent health care–associated pressure ulcers (decubitus ulcers), and identify safety risks inherent in its patient population.

The philosophy behind safety goals is that no adverse event should occur if knowledge exists to prevent it from happening. JCAHO views accreditation as a risk-reduction activity and compliance with the standards is meant to reduce the risk of adverse outcomes. To this end, JCAHO introduced nine patient safety solutions. These solutions are meant to guide the redesign of systems and process and prevent errors. The solutions are complex and 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.

JCAHO has a longstanding commitment to patient safety. This is demonstrated by 50% of accreditation standards related to patient safety, specific requirements are included for the response to adverse events, encourage prevention of accidental harm through analysis and redesign of systems, and recognize the organization’s responsibility to tell a patient about outcomes—good or bad.

More evidence to show that JCAHO is committed to patient safety: In 2003, developed Universal Protocol which is used for preventing wrong site, wrong procedure, and wrong person surgery. Established the Office of Quality Monitoring whose purpose is to evaluate complaints and reports of concerns about health care organizations relating to quality of care issues.

Still more evidence to show JCAHO is committed to patient safety:JCAHO has a Division of Quality Measurement and Research whose purpose is to address patient safety research from a variety of perspectives and works with external collaborators to advance the field. Also, 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.

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 where health care organizations were require to identify Sentinel Events and take action to prevent its recurrence. This was a really big deal for this time. Before this, health care organization only reported some of the deaths and critical injuries to CDC. Now, health care organizations were being held accountable for their actions.

A Sentinel Event is 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 can carry the risk of a serious adverse outcome. Some examples include performing a heart-lung transplant on the wrong patient, ordering the wrong blood type for transplanted organs, or overdosing a patient with anesthesia causing death.

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 evaluates processes 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.

Some of the Public Policy initiatives from JCAHO include Guiding principles for the Development of the Hospital of the Future and Development of a National Performance Measurement Data Strategy. JCAHO works with health care and patient safety advocates and Congressional Committees to urge the passage of legislation to enhance patient safety. On the state level, JCAHO works with state regulatory agencies and patient safety authorities to reduce duplicative reporting for accredited health care organizations.

Other Regulatory Agencies include FDA, AHA, and AMA. The FDA- Food and Drug Administration is part of the Department of Health and Human Services. Some of the duties of the FDA include performing drug approvals, providing drug safety information, and spreading the message about medication error through public health advisories, medication guides, and outreach programs.

The next two slides list the areas of responsibility for the FDA—Allergenics, Blood and Blood Products, Cellular and Gene Therapy Products, Drugs,Tissue and Tissue Products, Vaccines, Xenotransplantation, Development and Approval Process (Biologics), Guidance, Compliance, and Regulatory Information (Biologics), Safety and Availability (Biologics), 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), and Resources for You (Medical Devices). This is quite the breadth of areas. This covers everything from transplanting animal organs to medical devices, to blood and blood products for transfusion!

Another regulatory agency that governs the behavior of physicians is the American Medical Association (AMA). This agency provides many resources for physicians such as 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, and Legal Issues.

Another organization that advocates for hospitals is the American Hospital Association (AHA). The AHA is 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. The goal is to make federal policy-making relevant to the real work of taking care of people and keeping them well.

Component 1/Unit 6aHealth IT Workforce Curriculum1

Version 1.0/Fall 2010