Glossary of Patient Safety TermsMedical and surgical errors may result in 44,000 to 98,000 deaths annually.1 Adverse events may include medication errors, surgical mistakes, and surgical complications and cost our nation an estimated $37.6 billion each year.2 As issues related to medical errors are discussed, it is important to have a consistent vocabulary to help health care professionals categorize errors and adverse events. Categorizing and classifying errors and adverse events provides a structured way to ensure that when anyone talks about an “error,” he or she is not really discussing an “adverse event.”
To help clarify the need for a structured term set related to patient safety, examine the word error. Most leading safety experts agree that an error is an “unintended act, either of omission or commission, or an act that does not achieve its intended outcome.”3 Not all errors result in an adverse event or injury. For example, a medication may be administered late, but there may not be any negative outcomes for the patient. Therefore, it should not be classified as an adverse drug event.
For data collection purposes and clinical improvement efforts, the categorizing of an error as an adverse event could result in inaccurate data collection. Of more concern is that improvement efforts could be focused on the wrong problem or issues. Clarity and preciseness of terminology and definitions provides a basis for understanding and comparability for clinicians and researchers.
The First Consulting Group has prepared a “Patient Safety Glossary” in collaboration with the VHA to help clinicians, researchers, and others understand and use consistent vocabulary related to patient safety issues. This vocabulary was developed by patient safety experts and reflects the latest research and expert opinion on the topic.
This vocabulary is reprinted with permission from First Consulting Group and VHA (notes and resources have been adapted). It is offered to help clinicians, managers, and researchers classify and categorize errors and adverse events in health care environments. You are encouraged to use it in your efforts to improve patient safety. In some cases, the VHA Glossary lists more than one definition. To conserve space, we have listed only one definition for each term here.
Feedback about this vocabulary can be sent to AORN at research@aorn.org. Those comments, feedback, and suggestions will be provided to the First Consulting Group.
Accident—An event that involves damage to a defined system that disrupts the ongoing or future output of the future.4
Active error—An error that occurs at the level of the frontline operator and whose effects are felt almost immediately.5
Active failure—An error that is precipitated by the commission of errors and violations. These are difficult to anticipate and have an immediate adverse impact on safety by breaching, bypassing, or disabling existing defenses.6
Adverse drug event (ADE)—An injury resulting from the use of a drug.7
Adverse drug reaction (ADR)—A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. 8
Adverse event—An injury caused by medical management rather than the underlying condition of the patient.9
Compliance error—Inappropriate resident behavior regarding adherence to a prescribed medication regimen.10
Deteriorated drug error—Administration of a medication when the physical or chemical integrity of the dosage form has been compromised, such as expired medications, medications not properly stored, or medications requiring refrigeration that are left out at room temperature.11
Dispensing error—The failure to dispense a medication upon physician order (omission error) or within a specified period of time from receipt of the medication order or reorder (time error); dispensing the incorrect drug, dose, dosage form; failure to dispense correct amount of medication; inappropriate, incorrect, or inadequate labeling of medication; incorrect or inappropriate preparation, packaging, or storage of medication prior to dispensing; dispensing of expired, improperly stored, or physically or chemically compromised medications.12
Error—The failure of a planned action to be completed as intended (ie, error of execution) or the use of a wrong plan to achieve an aim (ie, error of planning).13
Error of commission—An error that occurs as a result of an action taken. Examples include when a drug is administered at the wrong time, in the wrong dosage, or using the wrong route; surgeries performed on the wrong side of the body; and transfusion errors involving blood cross-matched for another patient.14
Error of omission—An error which occurs as a result of an action not taken, for example, when a delay in performing an indicated cesarean section results in a fetal death, when a nurse omits a dose of a medication that should be administered, or when a patient suicide is associated with a lapse in carrying out frequent patient checks in a psychiatric unit. Errors of omission may or may not lead to adverse outcomes.15 (Also see “Omission Error.”)
Extra dose error—The administration of duplicate doses to a resident or administration of one or more dosage units in addition to those that were ordered. May include administration of a medication dose after the order was discontinued (which also could be considered an “Unauthorized Drug Error”).16
Injury—Untoward harm occurring to a patient.
Latent error—Errors in the design, organization, training, or maintenance that lead to operator errors and whose effects typically lie dormant in the system for lengthy periods of time.17
Latent failure—An error that is precipitated by a consequence of management and organizational processes and poses the greatest danger to complex systems. Latent failures cannot be foreseen but, if detected, they can be corrected before they contribute to mishaps.18
Medication error—Any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer.19
Monitoring errors—Failure to review a prescribed regimen for appropriateness, or failure to use appropriate clinical or laboratory data for adequate assessment of resident response to prescribed therapy.20
Omission error—The failure to administer an ordered dose to a resident by the time the next dose is due, assuming there has been no prescribing error. Exceptions would include a resident’s refusal to take the medication and failure to administer the dose because of recognized contraindications.21 (Also see “Error of Omission.”)
Potential adverse drug event—An incident with potential for injury related to a drug.22
Potential adverse event—An error of medical management that does not result in injury (“near misses”).23
Potential error—A mistake in prescribing, dispensing, or planned medication administration that is detected and corrected through intervention before actual medication administration.24
Prescribing error—The inappropriate selection of a drug (based on indication, contraindications, known allergies, existing drug therapy, and other factors); dose; dosage form; quantity; route of administration; concentration; rate of administration; or inappropriate or inadequate instructions for use of a medication ordered by a physician or other authorized prescriber.25
Preventable adverse drug event—An ADE due to an error or preventable by any means currently available.26
Preventable adverse event—An adverse event attributable to an error.27
Safety—Freedom from accidental injury.28
Sentinel event—An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called “sentinel” because they signal the need for immediate investigation and response.29
Type A—[ADEs] that are related to a drug’s pharmacological characteristics and are usually dose-dependent, predictable, and preventable.30
Type B—[ADEs] that are idiosyncratic or allergic in nature and are not dose-dependent or related to a drug's pharmacological characteristics.31
Unauthorized drug error—The administration of a medication to a resident for which the physician did not write an order. This category includes a dose given to the wrong resident, dose given that was not ordered, administration of the wrong drug or a discontinued drug, and doses given outside a stated set of clinical parameters or protocols.32
Unpreventable adverse drug event—An adverse [drug] event that is not attributable to an error [adapted].33
Unpreventable adverse event—An adverse event that is not attributable to an error.34
Wrong administration technique error—Use of an inappropriate procedure or improper technique in the administration of a drug. Examples of wrong technique errors include incorrect manipulation of inhalers, failure to maintain sanitary technique with medications, not wiping an injection site with alcohol, failure to use proper technique when crushing medications, failure to check nasogastric tube placement or flushing NG tube before and after administration of medication, failure to wash hands or improper hand washing technique used.35
Wrong dosage form error—The administration of a medication in a dosage form different from the one that was ordered by the prescriber. This could include crushing a tablet prior to administration without an order from the prescriber.36
Wrong dose error—When the resident receives an amount of medication that is greater than or less than the amount ordered by the prescriber.37
Wrong drug preparation error—A medication incorrectly formulated or manipulated before administration, such as incorrect or inaccurate dilution or reconstitution, failure to shake suspensions, crushing medications that should not be crushed, mixing drugs that are physically or chemically incompatible, and inadequate product packaging.38
Wrong rate error—The incorrect rate of administration of a medication to a resident. May occur with intravenous fluids or liquid enteral products.39
Wrong route error—The administration of a medication to a resident by a route other than that ordered by the physician or doses administered via the correct route but at the wrong site (eg, left eye instead of right eye).40
Wrong time error—The failure to administer a medication to a resident within a predefined interval from its scheduled administration time. This interval should be established by each facility and clearly stated in the facility’s policies. Different intervals may be established for different drugs or drug classes, based on the therapeutic importance of dosing.41
1. L T Kohn, J M Corrigan, M S Donaldson, Institute of Medicine, To Err is Human: Building a Safer Health System (Washington, DC: National Academy Press, 1999).
2. Ibid.
3. J Lazarou, B H Pomeranz, P N Corey, “Incidence of adverse drug reactions in hospitalized patients,” JAMA 279 (April 15, 1998) 1200-1205.
4. Kohn, Corrigan, Donaldson, Institute of Medicine, To Err is Human: Building a Safer Health System.
5. Ibid.
6. “Glossary of terms,” Joint Commission on Accreditation of Healthcare Organizations, http://www.jcaho.org (accessed March 2000).
7. D J Cullen et al, “The incident reporting system does not detect adverse drug events,” Joint Commission Journal on Quality Improvement 21 (October 1995) 541-548 (cited in the IOM Report).
8. WHO Technical Report 478 (1972) Definitions, “The UMC-The Global Intelligence Network for Benefits and Risks in Medicinal Products,” World Health Organization, http://www.who-umc.org/defs.
9. Kohn, Corrigan, Donaldson, Institute of Medicine, To Err is Human: Building a Safer Health System.
10. “Categories of medication errors,” in Med Pass Survey. A Continuous Quality Improvement Approach, J L Feinberg, ed (Alexandria, Va: American Society of Consultant Pharmacists, 1993) http://www.ascp.com.
11. Ibid.
12. Ibid.
13. Kohn, Corrigan, Donaldson, Institute of Medicine, To Err is Human: Building a Safer Health System.
14. “Glossary of terms,” Joint Commission on Accreditation of Healthcare Organizations, http://www.jcaho.org.
15. Ibid.
16. “Categories of medication errors,” in Med Pass Survey. A Continuous Quality Improvement Approach.
17. Kohn, Corrigan, Donaldson, Institute of Medicine, To Err is Human: Building a Safer Health System.
18. “Glossary of terms,” Joint Commission on Accreditation of Healthcare Organizations, http://www.jcaho.org.
19. “National Coordinating Council on Medication Error Reporting and Prevention,” Institute for Safe Medication Practices, Feb 2, 2000, http://www.ismp.org.
20. “Categories of medication errors,” in Med Pass Survey. A Continuous Quality Improvement Approach.
21. Ibid.
22. D W Bates et al, “Incidence of adverse drug events and potential adverse drug events,” JAMA 274 (July 5, 1995) 29-34.
23. Kohn, Corrigan, Donaldson, Institute of Medicine, To Err is Human: Building a Safer Health System.
24. “Categories of medication errors,” in Med Pass Survey. A Continuous Quality Improvement Approach.
25. Ibid.
26. Bates et al, “Incidence of adverse drug events and potential adverse drug events.”
27. Kohn, Corrigan, Donaldson, Institute of Medicine, To Err is Human: Building a Safer Health System.
28. Ibid.
29. “Sentinel Event Policy and Procedures,” June 2, 2000, Joint Commission on Accreditation of Healthcare Organizations, http://www.jcaho.org.
30. D C Classen et al, “Computerized surveillance of adverse drug events in hospital patients,” JAMA 266 (Nov 27, 1991) 2847-2851.
31. Ibid.
32. “Categories of medication errors,” in Med Pass Survey. A Continuous Quality Improvement Approach.
33. Kohn, Corrigan, Donaldson, Institute of Medicine, To Err is Human: Building a Safer Health System.
34. Ibid.
35. “Categories of medication errors,” in Med Pass Survey. A Continuous Quality Improvement Approach.
36. Ibid.
37. Ibid.
38. Ibid.
39. Ibid.
40. Ibid.
41. Ibid.
ResourcesL L Leape et al, “Reducing adverse drug events: Lessons form a breakthrough series collaborative,” The Joint Commission Journal on Quality Improvement 26 (June 2000) 321-331.
A W Asscher, G D Parr, V B Whitmarsh, “Towards the safer use of medicines,” British Medical Journal 321 (Oct 14, 1995) 1003-1005.
T R Einarson, “Drug-related hospital admissions,” Annals of Pharmacotherapy 27 (July 1993) 832-840 (cited in the IOM Report).
T A Brennan et al, “Incidence of adverse events and negligence in hospitalized patients,” New England Journal of Medicine 324 (Feb 7, 1991) 370-376.
Glossary of Risk Management Terms (Cambridge, Mass: Risk Management Foundation of the Harvard Medical Institutions, 2000) http://www.rmf.harvard.edu.
L B Andrews et al, “An alternative strategy for studying adverse events in medical care,” Lancet 349 (Feb 1, 1997) 309-313.
Draft of Revisions to Joint Commission Standards in Support of Medical/Health Care Error Reduction Programs in Accredited Organizations (Oakbrook Terrace, Ill: Joint Commission on Accreditation of Healthcare Organizations, 2000) http://www.jcaho.org.
D W Bates et al, “The impact of computerized physician order entry on medication error prevention,” JAMA 6 (July/August 1999) 313-321.
D G Wilson et al, “Medication errors in paediatric practice: Insights from a continuous quality improvement approach,” European Journal of Pediatrics 157 (September 1998) 769-774 (cited in the IOM Report).
L L Leape et al, “Systems analysis of adverse drug events,” JAMA 274 (July 5, 1995) 35-43 (cited in the IOM Report).
D J Cullen et al, “Preventable adverse drug events in hospitalized patients,” Critical Care Medicine 25 (August 1997) 1289-1297 (cited in the IOM Report).
L L Leape et al, “Preventing medical injury,” Quality Review Bulletin 19 (May 1993) 144-149 (cited in the IOM Report).
M D Rawlins, “Clinical pharmacology: Adverse reactions to drugs,” British Medical Journal 282 (March 21, 1981) 974-976.
|
|