The November 1999 report of the Institute of Medicine (IOM), entitled To Err Is Human: Building A Safer Health System (Washington, D.C.: National Academy Press, 1999), focused a great deal of attention on the issue of medical errors and patient safety. The report indicated that as many as 44,000 to 98,000 people die in hospitals each year as the result of medical errors. As part of a comprehensive strategy to improve patient safety, the IOM has called for the creation of external reporting systems to identify and learn from errors so as to prevent future occurrences.
According to the New England Journal of Medicine (published Dec. 12, 2002), 35% of the doctors surveyed and 42% of the public reported experiencing a medical error in their own care or in the care of a family member. Of these, 18% of the physicians and 24% of the public said the error had caused serious consequences such as death, long-term disability or severe pain.
Cost
Medical errors carry a high financial cost. The IOM report estimates that medical errors cost the Nation approximately $37.6 billion each year; about $17 billion of those costs are associated with preventable errors. About half of the
expenditures for preventable medical errors are for direct health care costs.
Key Legislation
Legislation has also been introduced in Congress to address patient safety. The Congressional Research Service's Stephen Redhead discussed the provisions of HR 663 and S 720, the Patient Safety Quality Improvement Act. Introduced in the 108th Congress, these two bills are designed to encourage reporting of medical errors by certifying patient safety organizations in each State to collect data and report on medical errors.
Source: "Reducing Medical Errors", Issue Module, Kaiser EDU.org, Accessed through www.kaiseredu.org.
Nationwide Mandatory Reporting System
In addition to describing the prevalence and possible causes of medical errors, the IOM report included several recommendations, some of which are directed toward States. One recommendation calls for a nationwide mandatory reporting system that provides for the collection of standardized information by State governments about adverse events that result in death or serious harm.
State Reporting: Mandatory vs Voluntary
Twenty-three states and the District of Columbia have medical error reporting laws or are currently considering such legislation:
Mandatory reporting: Colorado, Florida, Kansas, Nebraska, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Washington
Voluntary reporting: District of Columbia, Georgia, New Mexico, North Carolina, Oregon, Wyoming
Considering new legislation: Arizona, California, Maine
Mandatory reporting but considering new legislation: Massachusetts, New Jersey
Source: National Conference of State Legislatures; National Academy for State Health Policy, 12/03, Accessed through www.nashp.org.
Current Issues and Barriers
Under reporting of errors is a serious issue. The reasons for under reporting are numerous and include:
Facilities' lack of internal systems to identify events
Uncertainty about reporting requirements
A culture of non-reporting
A lack of enforcement at the state level
Bureaucratic burden
Competition and market share
Fear of publicity
Fear of liability
Source: "How States Report Medical Errors to the Public: Issues and Barriers"; National Academy for State Health Policy, Accessed through www.nashp.org.
JCAHO
Almost 50 percent of JCAHO standards are directly related to safety. Additional patient safety standards went into effect for hospitals in 2001. These standards address a number of significant patient safety issues, including the responsibility of organization leadership to create a culture of safety; the implementation of patient safety programs; the response to adverse events when they occur; the prevention of accidental harm through the prospective analysis and redesign of vulnerable patient systems and the organization’s responsibility to tell a patient about the outcomes of the care provided to the patient—whether good or bad.
Patient Safety-Related Standard
Identification of the errors that occur.
Analysis of each error to determine the underlying factors -- the "root causes" -- that, if eliminated, could reduce the risk of similar errors in the future.
Compilation of data about error frequency and type and the root causes of these errors.
Dissemination of information about these errors and their root causes to permit health care organizations, where appropriate, to redesign their systems and processes to reduce the risk of future errors.
Periodic assessment of the effectiveness of the efforts taken to reduce the risk of errors.
Source: "Patient Safety - Essentials for Health Care", 2nd edition; Joint Commission on Accreditation of Healthcare Organizations. Oakbrooke Terrace, IL: Department of Publications, 2004.
Sentinel Event Policy
JCAHO’s Sentinel Event Policy, implemented in 1996, is designed to help healthcare organizations to identify sentinel events and take action to prevent their recurrence. JCAHO stipulates that healthcare organizations shall have a process in place to recognize sentinel events. Any time a sentinel event occurs, the health care organization is expected to complete a thorough and credible root cause analysis, implement improvements to reduce risk, and monitor the effectiveness of those improvements. The root cause analysis must focus on process and system factors. The improvements must include documentation of a risk-reduction strategy and internal corrective action plan. The action plan must include measurements of the effectiveness of process and system improvements to reduce risk.
Source: "Sentinel Event Policies and Procedures - Revised: July 2002", Joint Commission on Accreditation of Healthcare Organizations, Accessed through http://www.jcaho.org/accredited+organizations/long+term+care/sentinel+events/index.htm.
Office of Quality Monitoring
JCAHO’s Office of Quality Monitoring receives, evaluates and tracks complaints and reports of concerns about health care organizations relating to quality of care issues. Information often comes from patients, their families or the public, as well as from an organization’s own staff, government agencies and others. When a report is submitted, JCAHO will take, in part, one of the following actions:
Incorporate the reported concern into the quality monitoring database that is used to track health care organizations over time to identify trends and patterns in their performance.
Ask the organization to provide a written response to the reported concern.
Review the reported concern and compliance with related standards at the time of the organization’s next accreditation survey, if it is scheduled in the near future.
Conduct an unannounced on-site evaluation of the organization if the report raises serious concerns about a continuing threat to patient safety or continuing failure to comply with standards.
Source: "Patient Safety - Essentials for Health Care", 2nd edition; Joint Commission on Accreditation of Healthcare Organizations. Oakbrooke Terrace, IL: Department of Publications, 2004.
CMS
The Centers for Medicare and Medicaid Services (CMS) has announced more aggressive actions in fighting billing fraud. As an invited guest speaker representing RPS at billing workshops in Chicago and San Diego in August of 2001, I listen to 2 FBI agents who specialized in Medicare fraud talk about their efforts to prosecute wrong doers in the radiation oncology billing field. Emerging areas of billing fraud included examples describing failures of QA policies and procedures and occurrences of medical errors in the treatment delivery process. They defined fraud as “any activity which is inconsistent with accepted sound medical, business or fiscal practices which directly or indirectly results in unnecessary costs, improper payment, payment for services which fail to meet professionally recognized standards of care …”. More Info...