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5 Error Reporting Systems
Pages 86-108

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From page 86...
... First, they provide the public with a minimum level of protection by assuring that the most serious errors are reported and investigated and appropriate follow-up action is taken. Second, they provide an incentive to health care organizations to improve patient safety in order to avoid the potential penalties and public exposure.
From page 87...
... As discussed in Chapter 6, reports submitted to voluntary reporting systems should be afforded legal protections from data discoverability. Health care organizations should be encouraged to participate in voluntary reporting systems as an important component of their patient safety programs.
From page 88...
... Mandatory reporting systems generally require health care organizations to submit reports on all serious adverse events for two reasons: they are easy to identify and hard to conceal. But it is only after careful analysis that the subset of reports of particular interest, namely those attributable to error, are identified and follow-up action can be taken.
From page 89...
... The Center for Patient Safety should · describe and disseminate information on existing voluntary reporting programs to encourage greater participation in them and track the development of new reporting systems as they form; · convene sponsors and users of external reporting systems to evaluate what works and what does not work well in the programs, and ways to make them more effective; · periodically assess whether additional efforts are needed to address gaps in information to improve patient safety and to encourage health care organizations to participate in voluntary reporting programs; and · fund and evaluate pilot projects for reporting systems, both within individual health care organizations and collaborative efforts among health care organizations. Voluntary reporting systems are an important part of an overall program for improving patient safety and should be encouraged.
From page 90...
... One approach involves mandatory reporting to an external entity. This approach is typically employed by states that require reporting by health care organizations for purposes of accountability.
From page 91...
... Since there are currently no examples of mandatory internal reporting with audit, the characteristics of the OSHA approach are described. Mandatory External Reporting State Adverse Event Tracking In a recent survey of states conducted by the Joint Commission on Accreditation of Healthcare Organizations NAVAHO)
From page 92...
... Several states had, or were planning to construct a database so that information could be tracked over time but had difficulty getting the resources or expertise to do so. Additionally, several states indicated that the information they received in reports from health care organizations was inadequate and variable.
From page 93...
... Voluntary External Reporting Joint Commission on Accreditation of Healthcare Organ izations ,tJCAHOJ JCAHO initiated a sentinel event reporting system for hospitals in 1996 (see Chapter 7 for a discussion on JCAHO activities related to accreditation)
From page 94...
... Root cause analyses ancl action plans are conficlential; they are clestroyocl after required data elements have been entered into a ICAHO database to be used for tracking ancl sharing risk reduction strategies. ICAHO encountered some resistance from hospitals when it introduced the sentinel event reporting program ancl is still working through the issues toclay.
From page 95...
... The ICAHO framework for conducting a root cause analysis is on the system for the convenience of reporters to download the forms, but the programs are not integrated. Aviation Safety Reporting System at NASA The three voluntary reporting systems described above represent focused initiatives that apply to a particular type of organization (e.g., hospital)
From page 96...
... The National Transportation Safety Board (NTSB) investigates aviation accidents.
From page 97...
... The deidentification of reports submitted to ASRS means that organizations do not have access to reports that identify problems in their own operations. In 1997, FAA established a demonstration program for the creation of Aviation Safety Action Programs (ASAP)
From page 98...
... . Key Points from Existing Reporting Systems There are a number of ways that reporting systems can contribute to improving patient safety.
From page 99...
... Many reporting systems are considered to be "passive" in that they rely on a report being submitted by someone who has observed the event.20 "Active" systems work with participating health care organizations to collect complete data on an issue being tracked to determine rates of an adverse event21 (e.g., the CDC conducted an active surveillance study of vaccine events with four HMOs linking vaccination records with hospital admission records22 )
From page 100...
... . Some states with mandatory reporting may also receive reports of medication-related adverse events.
From page 101...
... The committee believes that the focus of mandatory reporting systems should be on the top tier of the triangle in Figure 5.1. Errors in the lower tier are issues that might be the focus of voluntary external reporting systems, as well as research projects supported by the Center for Patient Safety and internal patient safety programs of health care organizations.
From page 102...
... Mandatory Reporting of Serious Adverse Events The committee believes there should be a mandatory reporting program for serious adverse events, implemented nationwide, linked to systems of accountability, and made available to the public. Comparable to aviation "accidents" that are investigated by the National Transportation Safety Board, health care organizations should be required to submit reports on the most serious adverse events using a standard format.
From page 103...
... Program features that might be evaluated include: factors that encourage or inhibit reporting, methods of analyzing reports, roles and responsibilities of health care organizations and the state in investigating adverse events, follow-up actions taken by states, information disclosed to the public, and uses of the information by consumers and purchasers. · 1 · 1 1 1 ~1 Although states should have flexibility in how they choose to implement the reporting program, all state programs should require reporting for a standardized core set of adverse events that result in death or serious injury, and the information reported should also be standardized.
From page 104...
... Federal enabling legislation and support will be required to direct the National Forum for Health Care Quality Measurement and Reporting to promulgate standardized reporting requirements for serious adverse events and encourage all states to implement the minimum reporting requirements. Such federal legislation pertaining to state roles may be modeled after the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
From page 105...
... For example, in its postmarketing surveillance of medical devices, FDA is moving away from a universal reporting system for hospitals and nursing homes to one in which a representative sample of hospitals and nursing homes keeps complete data. Its pilot test found that both the quantity and the quality of reports improved when FDA worked with a sample of hospitals who were trained in error identification and reporting and could receive feedback quickly.
From page 106...
... The committee does believe that voluntary reporting systems have a very important role to play in enhancing understanding of the factors that contribute to errors. When properly structured, voluntary systems can help to keep participating health care organizations focused on patient safety issues through frequent communication about emerging concerns and potential safety improvement strategies.
From page 107...
... 8. Joint Commission on Accreditation of Healthcare Organizations, Sentinel Event Alert, Number Three, May 1, 1998.
From page 108...
... A New Method for Active Surveillance of Adverse Events from Diphtheria/Tetanus/Pertussis and Measles/Mumps/ Rubella Vaccines. Lancet.


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