The requirements for patient safety incident reporting by community pharmacy contractors are set out in the Approved Particulars. As part of the clinical governance provisions in the Terms of Service, contractors have to report patient safety incidents to the NHS. The National Quality Forum NQF , established in May following the recommendation of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry, is a private, nonprofit voluntary consensus standards setting organization created to develop and implement a national strategy for the measurement and reporting of health care quality.
Acting on the IOM's recommendation, the NQF in released a list of 27 serious, preventable adverse events that should be reported by all licensed health care facilities. The list includes standardized definitions of key terms to encourage consistent use and implementation across the country.
Currently, HHS does not require health care institutions or providers to report information on medical errors. As a complement to the mandatory reporting of serious errors, the IOM recommended establishing voluntary reporting systems to collect information on less serious mistakes that result in little or no harm. Information gathered by voluntary reporting systems may be used to identify vulnerabilities and weaknesses in health care systems and to make improvements to prevent serious errors from occurring.
The IOM report and several more recent analyses have all highlighted the Aviation Safety Reporting System ASRS as a potential model for establishing national voluntary systems for reporting medical errors. ASRS was created in to encourage pilots, controllers, flight attendants, maintenance personnel, and others in the civilian airline industry to report incidents or situations in which aviation safety was compromised.
The program has become well-established and trusted within the airline industry and is credited with contributing to improvements in aviation safety over the past 28 years. ASRS analyzes the voluntarily submitted aviation safety incident reports to identify deficiencies and discrepancies in the national aviation system so that corrective action can be taken.
ASRS data are also used to support policies and planning for improving the national aviation system, and to strengthen the foundation of aviation human factors safety research. This is especially important given estimates that as much as two-thirds of all aviation accidents and incidents are rooted in human performance error.
ASRS provides feedback to the aviation community in the form of alert messages identifying problems that may require immediate action, analytical reports, an online database, a monthly safety newsletter, and a quarterly safety bulletin. ASRS receives more than 3, reports each month. Persons who submit reports are given two types of protection: confidentiality, and limited immunity from disciplinary action in the case of a potential violation of federal air regulations.
The FAA will not impose penalties upon individuals who complete and submit written incident reports to ASRS within 10 days after the violation provided that:. ASRS administrators attribute the program's success to various factors. Second, reporting is simple and involves a one-page form. Third, the program is responsive -- reporters receive timely feedback -- and viewed as worthwhile by those that use it.
And finally, the program is administered by an agency i. ASRS is seen as complementing the work of the National Transportation Safety Board NTSB , which investigates aviation accidents that result in death or serious injury or in which the aircraft sustains significant damage.
There are several national voluntary reporting systems for medical errors. In addition to its mandatory reporting requirements for drug and medical device manufacturers, the Food and Drug Administration also encourages health care providers and the public voluntarily to report suspected adverse events involving prescription and over-the-counter drugs.
The Department of Veterans Affairs VA , which manages one of the largest health care networks in the United States, is generally recognized as a leader in the growing patient safety movement. The PSIS is not a blame-free system. Events that are judged to be an intentionally unsafe act i.
Drawing on the experience of aviation and other "high-reliability" industries, NCPS officials argue that confidential, non-punitive reporting systems are key to identifying vulnerabilities and analyzing underlying systemic problems in health care. They contend that an over-reliance on punitive accountability systems has been a major impediment to improving patient safety.
Accountability systems do not encourage identification of potential problems, nor do they provide any incentive for reporting. It takes a systems approach to improving patient safety based on prevention, not punishment. Using tools developed by NCPS, multidisciplinary teams conduct a root cause analysis of reported adverse events. Root cause analysis is a process for identifying the causal factors that underlie an event. It focuses primarily on systems and processes, not individual performance.
The end product of a root cause analysis is an action plan outlining strategies that the organization intends to implement to reduce the risk of a similar event occurring in the future. The PSIS now serves as a benchmark and is being used and emulated by other health care programs, nationally and internationally. It is intended to provide VA employees with a "safety valve" that allows them confidentially to report close calls or adverse events that, for whatever reason, would otherwise go unreported.
All personnel and facility names, facility locations, and other potentially identifying information are removed before reports are entered into the PSRS database. Only NASA personnel assigned to the reporting system can review data until the de-identification process is complete. JCAHO is an independent, nonprofit organization that evaluates and accredits nearly 18, health care organizations and programs in the United States, including hospitals, health care networks, managed care organizations, and health care organizations that provide home care, long term care, behavioral health care, laboratory, and ambulatory care services.
JCAHO initiated a sentinel event reporting system for hospitals in A sentinel event is defined as one that results in an unanticipated death or major permanent loss of function not related to the natural course of the patient's illness or underlying condition.
Sentinel events also include: patient suicide in a setting that provides round-the-clock care; rape; infant abduction or discharge to the wrong facility; major incompatibility reactions in blood transfusion recipients; and surgery on the wrong patient or body part. Accredited hospitals are expected to identify and respond to all sentinel events by conducting a root cause analysis, implementing improvements to reduce risk, and monitoring the effectiveness of those improvements. To encourage sentinel event reporting, JCAHO has established a policy of not penalizing the accreditation status of an organization that reports such events and performs a root cause analysis.
If a hospital fails to report an event and JCAHO learns of it from a third party, it requires the hospital to conduct a root cause analysis or risk loss of accreditation. Despite these efforts, few hospitals report sentinel events because they view the program as cumbersome, time-consuming, unresponsive, and potentially risky.
They are concerned about the confidentiality of the information and fear that public disclosure of reports may damage their reputation and lead to a decline in business, a loss of license or accreditation, and litigation. Medication Errors Reporting Program.
The Medication Errors Reporting MER program was started in by the Institute for Safe Medication Practices ISMP , a nonprofit organization that works with healthcare practitioners, regulatory agencies, professional organizations, and the pharmaceutical industry to provide education about adverse drug events and their prevention. Since , the MER program has been owned and administered by the U. Pharmacopeia USP. USP is a nonprofit, private organization that establishes legally recognized standards for the quality, strength, purity, packaging, and labeling of medicines for human and veterinary use.
The MER program receives voluntary and confidential reports from practitioners -- primarily pharmacists -- via mail, telephone, and the Internet. Reporters are informed that a de-identified copy of the report is routinely sent to ISMP, the Food and Drug Administration FDA , and the pharmaceutical company whose product is mentioned in the report.
With permission, the reporter's name is disclosed to ISMP, which provides an independent review of the report. Errors or near-errors reported through the MER program include administering the wrong drug, strength, or dose, confusion over look-alike and sound-alike drugs, incorrect route of administration, and errors in prescribing and transcribing.
ISMP publishes biweekly reports with recommendations and periodic special alerts. MedMARx Program. Hospitals must subscribe to MedMARx in order to use the program. Employees of hospitals that subscribe may report a medication error anonymously to MedMARx by completing a standardized form. Hospital management is then able to retrieve compiled data on its own facility and also obtain nonidentifiable comparative information on other participating hospitals.
Information is not shared with FDA. The JCAHO framework for conducting a root cause analysis is on the MedMARx system for the convenience of reporters to download the forms, but the programs are not integrated. The report also includes a five-year trend analysis of data submitted to MedMARx between and , with a focus on technology related errors.
MedMARx has received generally favorable reviews from analysts. The program incorporates some of the same design features that are found in ASRS.
Hospital employees view MedMARx reporting as relatively safe and straightforward. Unlike JCAHO's system for hospitals to report events with serious outcomes, MedMARx relies on individual employees submitting anonymous reports of all types of medication errors, whether or not they result in harm. MedMARx is also very responsive. The data are analyzed by experts, and reporters receive timely feedback of useful information. Food and Drug Administration. The FDA regulates the manufacturers of prescription and over-the-counter drugs, medical and radiation-emitting devices, and biological products e.
After FDA approves a new drug or device, the agency continues to monitor its safety through postmarketing surveillance. Adverse event reporting is a major component of postmarketing surveillance. For medical devices, manufacturers are required to report deaths, serious injuries, and malfunctions to FDA. Hospitals, nursing homes, and other user facilities are also required to report deaths to both the manufacturer and FDA, and to report serious injuries to the manufacturer.
For suspected adverse events associated with drugs, reporting is mandatory for manufacturers. Health care professionals and consumers may voluntarily report suspected adverse drug events and device problems through FDA's Medical Products Reporting Program, MedWatch, which allows reporting by phone toll-free , fax, direct mail using a postage-paid form , and Internet.
All MedWatch reports are evaluated and entered into one of the agency's databases for analysis. FDA receives approximately , reports annually for adverse drug events and more than 80, reports on device problems. The agency decides whether any corrective action is necessary on a case-by-case basis, by considering the unexpectedness and seriousness of the event, the vulnerability of the population affected, and the available options for prevention.
If corrective action is warranted, FDA generally pursues one of three strategies. The first and most common strategy is to negotiate with the manufacturer to make the desired changes. Second, FDA may take regulatory action to compel a manufacturer to act. Finally, the agency may attempt to inform health care professionals and the public about the risks associated with a particular drug through published articles, direct mailings, and the Internet.
On February 26, , FDA published a final rule requiring bar codes on the labels of most prescription drugs and all over-the-counter drugs used in hospitals and dispensed pursuant to a physician's order. In addition, the rule requires bar codes on the labels of blood and blood components used for transfusion. On March 14, , FDA proposed revising manufacturer's reporting requirements to improve the agency's ability to monitor and improve the safe use of medications.
An example of a potential medication error would be a pharmacist who selects the wrong drug because of a similar sounding name but catches the mistake before dispensing the medication. If the pharmacist elects to report the incident to the manufacturer, then under the proposed rule the manufacturer must report it to FDA.
The proposal also requires the use of internationally agreed definitions and reporting formats, which will allow companies to prepare a single report for submission to major regulatory agencies worldwide.
Table 2 summarizes the design features that analysts have identified as essential for an effective reporting program. An effective program is one that encourages reporting, analyzes the data to identify vulnerabilities in the health care system, and promotes the development of preventive strategies to improve patient safety.
For one thing, several national reporting systems already exist, particularly for medication errors. Moreover, a comprehensive national reporting system would require an enormous investment in funding and personnel, in view of the potential volume of reports.
With an estimated 1 million errors each year in hospital settings alone, plus an even greater number of close calls, the analysis of even a fraction of these events would require many expert analysts, all of whom would have to be recruited and trained. Table 2. The IOM said that the existing reporting systems should be encouraged and promoted within health care organizations and that better use should be made of the reported information.
New systems should be focused on specific areas of medical care e. That approach would help manage the potential volume of reports and match the expertise to the problems. There also needs to be a mechanism for sharing information across different reporting systems. A report in one system may have relevance for another system e. Along with its recommendation on reporting systems, the IOM also recommended the establishment of a federal Center for Patient Safety to set national goals, fund research, evaluate methods for identifying and preventing medical errors, and disseminate information on best practices.
To encourage providers to report errors without fear of the data being used in a medical malpractice lawsuit, the IOM recommended that information collected under a voluntary reporting system be protected from legal discovery and admission as evidence in civil cases. The Patient Safety and Quality Improvement Act seeks to implement that recommendation by providing legal protection for information about medical errors that is voluntarily submitted to patient safety organizations PSOs.
PSOs would collect and analyze the information submitted by providers and develop and disseminate recommendations for systems-based solutions to improve patient safety and health care quality.
This section of the report provides an overview of H. That is followed by some analysis of key differences between H. And if you do choose to submit as a logged-in user, your name will not be publicly associated with the case. Learn more information here. Provide Feedback Submit a Case. Use quotes to search for an exact match of a phrase. Example: "communication between providers and nurses". Put a minus sign just before words you don't want. Example: "adverse events" -"drug". Example: medication safety.
The PSNet Collection. Patient Safety Training and Education. Improvement Resources. About PSNet. The Fundamentals Primers Topics Glossary. All Content. Current Weekly Issue. Past Weekly Issues. Curated Libraries. The Fundamentals. Continuing Education. Training Catalog. Editorial Team. Technical Expert Panel. Copy URL. Background Patient safety event reporting systems are ubiquitous in hospitals and are a mainstay of efforts to detect patient safety events and quality problems. Characteristics of Incident Reporting Systems An effective event reporting system should have four key attributes : Box.
Key Components of an Effective Event Reporting System Institution must have a supportive environment for event reporting that protects the privacy of staff who report occurrences. Reports should be received from a broad range of personnel. Summaries of reported events must be disseminated in a timely fashion.
A structured mechanism must be in place for reviewing reports and developing action plans. Department of Health and Human Services. Readers should not interpret any statement in this report as an official position of AHRQ or of the U. None of the authors has any affiliation or financial involvement that conflicts with the material presented in this report. Characteristics of Incident Reporting Systems.
Using Event Reports to Improve Safety. Related Patient Safety Primers. Culture of Safety. Integrating incident data from five reporting systems to assess patient safety: making sense of the elephant.
The elephant of patient safety: what you see depends on how you look. Patient safety reporting systems: sustained quality improvement using a multidisciplinary team and "Good Catch" awards. Patient Safety Primers. September 7, Predictors of nursing home nurses' willingness to report medication near-misses.
May 13, Dashboards for visual display of patient safety data: a systematic review. October 27, Incident Reporting. Institutional Reporting. Error Reporting. Back To Top. Patient Safety Primers Topics Glossary. Improvement Resources Innovations Toolkits. Connect With Us. Sign up for Email Updates To sign up for updates or to access your subscriber preferences, please enter your email address below.
0コメント