Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 2 (Sept. 2005) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority ICU Reports More Likely to be Reported as Serious Events Patients in intensive care units 1,000 ICU days, including near misses as well as PA-PSRS (ICUs) may be more likely harmful events.4 In terms of errors (as distinct from than non-ICU patients to be adverse events) a study of a single university-based Data Brief injured by adverse events. The medical-surgical ICU estimated an error rate of 1.7 procedures performed on criti- per patient day.5 cally ill patients and the quantity and type of drugs An analysis of reports submitted to PA-PSRS sup- used in their care may also increase their risk rela- ports the hypothesis that ICU patients may have an tive to non-ICU patients.1 increased risk of injury from adverse events. Among An analysis of one year’s data from seven Austra- reports from hospitals, reports involving the ICU lian ICUs collected 536 reports, identifying 610 inci- were about 20% more likely to be identified as Seri- dents, that reduced or could have reduced the ous Events* than those that did not involve the ICU. “safety margin” for the patient (i.e., it included near As shown in Figure 1, reports of Adverse Drug Re- misses and no-harm events).2 A recent one-year actions† were 2.4 times as likely to be identified as observational study estimated the rate of adverse Serious Events if they involved the ICU. Reports of events in the ICU as 80.5 per 1,000 patient days.3 Medication Errors and Complications of Procedures, Another study reported a rate of 89 events per Figure 1. Reports from ICUs Identified as Serious Events, Relative to Non-ICU Reports (Based on Reports Submitted by Hospitals from 6/7/04 through 6/6/05) 4 3.5 Relative Risk Ratio (95% Confidence Intervals) 3 For categories in which the lower end of the confidence Intervals is greater than 1, the relative risk ratio is statistically 2.5 2.43 significant. 2 1.88 1.73 1.5 1.25 1.21 1.19 1 0.95 0.77 0.81 0.81 0.5 0 Medication Adverse Drug Equipment / Falls Errors Related Complication Transfusion Skin Integrity Other / All Reports Errors Reactions Supplies / to Procedures of Procedures Miscellaneous Devices / Treatments / / Treatments / Tests Tests *Relative Risk Ratio was 1.205 (95% C.I.: 1.113,1.305). For readers who This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 3, No. may not be familiar with the statutory definitions, PA-PSRS staff receives 2—Sept. 2005. The Advisory is a publication of the Pennsylvania Patient two types of reports: Serious Events (similar to “adverse events”) and Safety Authority, produced by ECRI & ISMP under contract to the Authority as Incidents (similar to “near misses” and “no-harm events”). part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). †The World Health Organization (WHO) defines Adverse Drug Reaction Copyright 2005 by the Patient Safety Authority. This publication may be re- (ADR) as “Any response to a drug which is noxious and unintended, and printed and distributed without restriction, provided it is printed or distributed in which occurs at doses normally used in man for prophylaxis, diagnosis, or its entirety and without alteration. Individual articles may be reprinted in their therapy of disease, or for the modification of physiological function.” entirety and without alteration provided the source is clearly attributed. Source: WHO. Requirements for adverse reaction reporting. Geneva, Switzerland: WHO; 1975. To see other articles or issues of the Advisory, visit our web site at www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2005 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 2 (Sept. 2005) ICU Reports More Likely to be Reported as Serious Events (Continued) Treatments, and Tests were 88% and 19% more Table 1 presents the most frequently cited contrib- likely to be Serious Events, respectively uting factors in ICU-related reports providing de- tailed causative information. Factors shown on this During the first year of mandatory reporting, Penn- table are those with at least a 1-in-10 likelihood of sylvania hospitals submitted 11,959 reports identi- being cited as a contributing factor in the set of ana- fied as occurring in the ICU (or 17.7 reports per lyzed reports. All of the contributing factors shown 1,000 ICU patient days‡). Of those reports, 5.4% related to staff, team, environment, and organiza- were Serious Events, a significantly greater propor- tional factors were significantly more likely to be tion than that from non-ICU areas.§ Reports involv- reported in ICU-related reports than from other re- ing the ICU accounted for 8.5% of all reports sub- ports from hospitals. Patient compliance and patient mitted by hospitals. Figure 2 presents the number of understanding were significantly less likely to be reports from ICU and non-ICU areas by Event Type cited as a contributing factor in ICU-related reports. in terms of the number of patient days. Figure 2. Reports per 1,000 Patient Days by Event Type and ICU Involvement (Based on Reports Submitted by Hospitals from 6/7/04 through 6/6/05) 6.0 5.1 5.0 Reports per 1,000 Patient Days 4.1 4.0 3.6 3.6 3.3 3.0 ICU 3.0 Non-ICU 2.3 2.0 2.0 1.6 1.2 1.3 0.9 1.0 0.5 0.3 0.3 0.3 0.3 0.2 0.0 Medication Adverse Drug Equipment / Falls Errors Related Complication of Transfusion Skin Integrity Other / Errors Reactions Supplies / to Procedures / Procedures / Miscellaneous Devices Treatments / Treatments / Tests Tests ‡ Based on data from: Pennsylvania Department of Health, Bureau of Health Statistics and Research. Hospital and ambulatory surgery center data, standard output reports 2003-2004, Report 2A, Inpatient hospital unit data by facility and county. Reporting period: July 1, 2003, through June 30, 2004. Accessed 15 Aug 2005. Available online at www.health.state.pa.us. § Based on a Chi square test of significance (p<0.05). Page 2 ©2005 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 2 (Sept. 2005) ICU Reports More Likely to be Reported as Serious Events (Continued) Table 1. Frequently Cited Contributing Factors in Reports Related to the ICU (Based on Reports Submitted by Hospitals from 6/7/04 through 6/6/05) Selected ICU-Related Reports Citing Relative Risk Ratio Significance Relative to Contributing Factors this Factor (%)a (with 95% CI)b Non-ICU-Related Reportsc Staff, Team, Environment, and Organizational Factors Failure to follow procedures 36.5 1.24 (1.17-1.31) Higher Communication 25.6 1.29 (1.20-1.38) Higher Staff proficiency 22.7 1.19 (1.10-1.29) Higher Distractions 12.0 1.13 (1.01-1.27) Higher Training 9.6 1.50 (1.32-1.71) Higher Patient–Related Factors Patient compliance 17.0 0.60 (0.55-0.66) Lower Patient understanding 9.7 0.85 (0.75-0.97) Lower (a) Proportion is based only on reports that provided detailed information on contributing factors. (b) A ratio of the likelihood that a contributing factor will be cited in an ICU-related report relative to the likelihood that the same fac- tor will be cited in a non-ICU-related report. For example, “Training” is 50% more likely to be cited as a contributing factor in an ICU- related report than a non-ICU-related report. (c) Based on Chi square tests of significance (p<0.05). Notes 1. Cullen DJ, Sweitzer BJ, Bates DW, et al. Preventable adverse drug events in hospitalized patients: a comparative study of intensive care units and general care units. Crit Care Med. 1997 Aug;25(8):1289-97. 2. Beckmann U, Baldwin I, Hart GK, Runciman WB. The Australian incident monitoring study in intensive care (AIMS-ICU). An analysis of the first year of reporting. Anaesth Intensive Care. 1996 Jun;24(3):311-3. 3. Rothschild JM, Landrigan CP, Cronin JW, et al. The critical care safety study: the incidence and nature of adverse events and seri- ous medical errors in intensive care. Crit Care Med. 2005 Aug;33(8):1694-1700. 4. Osmon S, Harris CB, Dunagan WC. Crit Care Med. Reporting of medical errors: An intensive care unit experience. 2004 Mar; 32 (3):727-33. 5. Donchin Y, Gopher D, Olin M, et al. A look into the nature and causes of human errors in the intensive care unit. Crit Care Med. 1995;23;294-300. ©2005 Pennsylvania Patient Safety Authority Page 3 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 2 (Sept. 2005) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. Page 4 ©2005 Pennsylvania Patient Safety Authority