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In science and engineering, root cause analysis (RCA) is a method of problem solving used for identifying the root causes of faults or problems. It is widely used in IT operations, manufacturing, telecommunications, industrial process control, accident analysis, medicine, healthcare industry, etc. Root cause analysis is a form of inductive and deductive inference.
Plasmapheresis is the removal, treatment, and return or exchange of blood plasma or components thereof from and to the blood circulation. It is thus an extracorporeal therapy, a medical procedure performed outside the body.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
The Joint Commission is a United States-based nonprofit tax-exempt 501(c) organization that accredits more than 22,000 US health care organizations and programs. The international branch accredits medical services from around the world.
Outpatient surgery, also known as ambulatory surgery, day surgery, day case surgery, or same-day surgery, is surgery that does not require an overnight hospital stay. The term “outpatient” arises from the fact that surgery patients may enter and leave the facility on the same day. The advantages of outpatient surgery over inpatient surgery include greater convenience and reduced costs.
A biomedical engineering/equipment technician/technologist or biomedical engineering/equipment specialist is typically an electro-mechanical technician or technologist who ensures that medical equipment is well-maintained, properly configured, and safely functional. In healthcare environments, BMETs often work with or officiate as a biomedical and/or clinical engineer, since the career field has no legal distinction between engineers and engineering technicians/technologists.
An independent medical review (IMR) is the process where physicians review medical cases in order to provide claims determinations for health insurance payers, workers compensation insurance payers or disability insurance payers. Peer review also is used in order to define the review of sentinel events in a hospital environment for quality management purposes such as to look at bad outcomes and determine whether there was any mis-diagnosis, mistreatment or any systemic problems involved which led to the sentinel event.
Patient safety is a discipline that emphasizes safety in health care through the prevention, reduction, reporting and analysis of error and other types of unnecessary harm that often lead to adverse patient events. The frequency and magnitude of avoidable adverse events, often known as patient safety incidents, experienced by patients was not well known until the 1990s, when multiple countries reported significant numbers of patients harmed and killed by medical errors. Recognizing that healthcare errors impact 1 in every 10 patients around the world, the World Health Organization (WHO) calls patient safety an endemic concern. Indeed, patient safety has emerged as a distinct healthcare discipline supported by an immature yet developing scientific framework. There is a significant transdisciplinary body of theoretical and research literature that informs the science of patient safety with mobile health apps being a growing area of research.
A Patient Safety Organization (PSO) is a group, institution, or association that improves medical care by reducing medical errors. Common functions of patient safety organizations are data collection, analysis, reporting, education, funding, and advocacy. A PSO differs from a Federally designed Patient Safety Organization (PSO), which provides health care providers in the U.S. privilege and confidentiality protections for efforts to improve patient safety and the quality of patient care delivery
A near miss, near death, near hit or close call is an unplanned event that has the potential to cause, but does not actually result in human injury, environmental or equipment damage, or an interruption to normal operation.
Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions.
Corrective and preventive action consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring non-conformance. Non-conformance is identified after systematic evaluation and analysis of the root cause of the non-conformance. Non-conformance may be a market complaint or customer complaint or failure of machinery or a quality management system, or misinterpretation of written instructions to carry out work. The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of non-conformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation. The Eight disciplines problem solving method, or 8D framework, can be used as an effective method of structuring a CAPA.
A never event is the "kind of mistake that should never happen" in the field of medical treatment. According to the Leapfrog Group never events are defined as "adverse events that are serious, largely preventable, and of concern to both the public and health care providers for the purpose of public accountability."
Medical equipment management is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare technology. These healthcare technology managers are, much like other healthcare professionals referred to by various specialty or organizational hierarchy names.
Critical Test Results Management (CTRM) also known as Critical Test Results Reporting, and Closed-Loop Reporting, is the software that handles a medical test result that has come back as critical to a patient’s health. CTRM software prevents the critical result from being lost in communication failures, improves patient safety, and documents the delivery of the results.
The Patient Safety and Quality Improvement Act of 2005 (PSQIA): Pub. L.Tooltip Public Law 109–41 (text)(PDF), 42 U.S.C. ch. 6A subch. VII part C, established a system of patient safety organizations and a national patient safety database. To encourage reporting and broad discussion of adverse events, near misses, and dangerous conditions, it also established privilege and confidentiality protections for Patient Safety Work Product. The PSQIA was introduced by Sen. Jim Jeffords [I-VT]. It passed in the Senate July 21, 2005 by unanimous consent, and passed the House of Representatives on July 27, 2005, with 428 Ayes, 3 Nays, and 2 Present/Not Voting.
A retained surgical instrument is any item inadvertently left behind in a patient’s body in the course of surgery. There are few books about it and it is thought to be underreported. As a preventable medical error, it occurs more frequently than "wrong site" surgery. The consequences of retained surgical tools include injury, repeated surgery, excess monetary cost, loss of hospital credibility and in some cases the death of the patient.
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
Barcode technology in healthcare is the use of optical machine-readable representation of data in a hospital or healthcare setting.
Credentialing is the process of establishing the qualifications of licensed medical professionals and assessing their background and legitimacy.
References
- 1 2 https://www.pressganey.com/docs/default-source/default-document-library/hpi-white-paper---sec-amp-sser-measurement-system-rev-2-may-2011.pdf [ bare URL PDF ]
- ↑ A fatal transfusion reaction must be reported within 7 days.
- ↑ "Summary Data of Sentinel Events Reviewed by The Joint Commission" (PDF). www.jointcommission.org. 2016. Retrieved 2019-07-09.
- ↑ Joint Commission on Accreditation of Healthcare Organizations: Sentinel Event Alerts