Which of the Following Can Be Defined as a Voluntary System of Institutional Review

• Journal List
• J Gen Intern Med
• five.21(2); 2006 February
• PMC1484668

J Gen Intern Med. 2006 Feb; 21(2): 165–170.

Voluntary Electronic Reporting of Medical Errors and Adverse Events

An Analysis of 92,547 Reports from 26 Acute Care Hospitals

Catherine Due east Milch, MD,¹ Deeb N Salem, MD,² Stephen G Pauker, MD,ⁱⁱⁱ Thomas G Lundquist, Medico, MMM,^{3, 4, five} Sanjaya Kumar, MD, MSc,^vi and Jack Chen, BM, BS^vi

Catherine E Milch

^aneDepartment of Medicine and the Institute for Clinical Research and Health Policy Studies, Tufts-New England Medical Center, Boston, MA, USA

Deeb North Salem

²Section of Medicine, Partitioning of Cardiology, Tufts-New England Medical Center, Boston, MA, USA

Stephen Chiliad Pauker

³Department of Medicine, Division of Clinical Decision Making, Tufts-New England Medical Center, Boston, MA, U.s.a.

Thomas G Lundquist

ⁱⁱⁱSection of Medicine, Division of Clinical Decision Making, Tufts-New England Medical Centre, Boston, MA, Us

^fourI-trax Health Direction Solutions, Philadelphia, PA, USA

⁵Section of Pediatrics, Nemours Children's Infirmary, Jacksonville, FL, Usa, and Bryn Mawr Hospital, Bryn Mawr, PA, U.s.

Sanjaya Kumar

⁶Quantros Inc., Milpitas, CA, United states of america

Jack Chen

⁶Quantros Inc., Milpitas, CA, U.s.a.

Received 2005 Mar three; Revisions requested 2005 Sep 15; Revised 2005 Sep 26

Supplementary Materials

Appendix: Examples of the reporting organization input screens and reports, and institutional reporting rates.

GUID: F5976E07-E09D-4746-91B8-E33DE47244DD

Abstract

OBJECTIVE

To describe the rate and types of events reported in acute care hospitals using an electronic fault reporting arrangement (e-ERS).

Pattern

Descriptive report of reported events using the same e-ERS betwixt January i, 2001 and September 30, 2003.

SETTING

Twenty-six acute care nonfederal hospitals throughout the U.South. that voluntarily implemented a web-based e-ERS for at least 3 months.

PARTICIPANTS

Hospital employees and staff.

INTERVENTION

A secure, standardized, commercially available web-based reporting organization.

RESULTS

Median duration of e-ERS employ was 21 months (range 3 to 33 months). A total of 92,547 reports were obtained during two,547,154 patient-days. Reporting rates varied widely across hospitals (ix to 95 reports per 1,000 inpatient-days; median=35). Registered nurses provided nearly half of the reports; physicians contributed less than 2%. Xxx-iv percent of reports were classified as nonmedication-related clinical events, 33% as medication/infusion related, xiii% were falls, 13% as administrative, and 6% other. Amidst fourscore% of reports that identified level of impact, 53% were events that reached a patient ("patient events"), 13% were near misses that did not reach the patient, and 14% were infirmary environment problems. Amid 49,341 patient events, 67% caused no harm, 32% temporary harm, 0.8% life threatening or permanent impairment, and 0.4% contributed to patient deaths.

CONCLUSIONS

An e-ERS provides an accessible venue for reporting medical errors, agin events, and about misses. The broad variation in reporting rates among hospitals, and very depression reporting rates past physicians, requires investigation.

Keywords: medical errors, adverse events, error reporting systems, electronic reporting

"Wellness care organizations should be encouraged to participate in voluntary reporting systems as an important component of their patient prophylactic programs." In To Err is Human: Building a Safer Health Organization. Constitute of Medicine, 2000.¹

The reporting of medical errors (an incorrect activeness or plan that may or may not cause damage to a patient), adverse events (injury to a patient because of medical management, not necessarily because of error), and nearly misses (an error that does not reach the patient) has been a focus of efforts to reduce their incidence. Evaluation of the types, frequency, and furnishings on patients and their care of errors and adverse events are disquisitional for understanding defects in processes of intendance, identifying "root causes," and developing interventions aimed at their reduction and prevention.^{1 – 3} 2 commonly used methods for error detection, direct ascertainment and nautical chart review, are personnel-and fourth dimension-intensive, and thus impractical for routine implementation across medical care settings.^{iv – 6} Malpractice claims information are discipline to reporting bias; administrative data may not include clinical context and/or data on near misses (errors that did non accomplish the patient) or latent errors (defects in the hospital environment and operations that can atomic number 82 to medical errors and agin events).^{6 – 8}

Voluntary error reporting systems (ERS) were strongly endorsed in the Institute of Medicine's report on errors in medical careⁱ and terminal year the U.S. Senate passed an amendment to The Public Health Safe Deed to constitute a framework for wellness care providers to voluntarily report medical errors to patient safety organizations with confidentiality protections.⁹

Existing reporting systems, such as the Sentinel Effect organisation of the Joint Commission for Accreditation of Health Care Organizations (JCAHO) and the MedMARx organization of the United Sates Pharmacopeia and the Constitute for Safe Medication Practices, are limited to certain types of errors and adverse events, and may not collect reports on almost misses, and/or may not be familiar or accessible to all hospital employees.^{10 , xi} Hospital-based electronic ERS (due east-ERS) may facilitate voluntary reporting of all types of medical errors and adverse events through ease of use and accessibility, and may permit real-time review, oversight, and intervention. Additionally, an due east-ERS that captures well-nigh misses and latent errors may provide farther insights into organization processes that need to exist modified to help reduce the likelihood of error. To illustrate the feasibility of reporting and types of events reported using a hospital-based e-ERS, we describe reports obtained from 26 U.S. acute care hospitals that implemented the same commercially available e-ERS.

METHODS

Institutions

We evaluated all reported events from 26 acute care nonprofit, nonfederal hospitals throughout the U.S. that voluntarily implemented a web-based e-ERS for at least 3 months. Each hospital implemented and used the same commercial production (DrQuality) as a component of quality improvement efforts. Twenty-4 hospitals were adult or adult/pediatric tertiary care centers, 2 were exclusively pediatric, 9 were bookish medical centers, 11 hospitals were in urban, 13 in suburban, and 2 in rural settings. The hospitals were located in 12 geographically dispersed states. Eighteen hospitals were role of infirmary groups or health intendance systems each comprising of several facilities. The first facility in the accomplice implemented the e-ERS in Nov 2000, and the final facility in June 2003.

Reporting System

The reporting organisation consisted of a secure, web-based portal available on all hospital PCs. Whatever infirmary employee could submit a report after a secure login. The reporting arrangement leads the reporter through a series of standardized screens with pull-downwardly response choices designed to collect information on event demographics including fourth dimension, location, and service, and personnel involved, besides every bit type of event, contributing factors, bear upon on patient care, and subsequent patient outcome. The reporting procedure took an boilerplate of 10 minutes to complete. Although reporting was not anonymous, reports were peer-review protected at each hospital site and accessible only to prespecified hospital personnel. In most cases, the chief medical officer and quality improvement executives had admission to all reports; ward leaders (nurse managers and attending physicians) had access to and responsibility for all events that occurred on their ward; pharmacy leaders had access to all medication-related events; and so on. Reports could exist accessed immediately after entry, and could be amended to reverberate information obtained from subsequent investigation, verification, and patient follow-up. Managers and executive leadership could also edit reports for accuracy during terminal review. Figure 1 in the on-line Appendix shows examples of the e-ERS input screens.

Diagram of impact level categories and study definitions.

Report Definitions

In each reporting session, reporters specified a major category for each event: (a) Nonmedication-related clinical (events related to medical management, excluding administration, delivery, or reaction to medications), (b) Medication/infusion (events related to the administration, delivery, dosing, or reaction to medications), (c) Authoritative (including events related to system processes and infrastructure problems), (d) Falls, or (east) Other. Examples of the types of events in each major category are listed in Table 1 in the on-line appendix.

Table 1

Virtually Mutual Reported Events Within Each Major Category of Event

Nonmedication Clinical Events, due north=31,900	%	Medication/Infusion Events, n=xxx,988	%	Administrative Events, north=11,857	%
Laboratory	34	Wrong dose	16	Discharge process	25
Transfusion related	x	Omitted drug	16	Documentation	14
Operative/invasive procedures	9	Wrong drug	12	Property loss	7
Peel integrity	8	Drug reaction/allergy	ten	Communication	seven
Nonoperative test/treatment	vii	Wrong route	8	Patient/family unit dissatisfaction	7
Blood/body fluid exposure	3	Incorrect time/frequency	vii	Medical device/equipment	half-dozen
Respiratory direction	two	Wrong form/infusion rate	4	Patient identification	half dozen
		Wrong patient	3	Consent process	four
Infiltration/extravasation	ii	Admission process	3
Controlled substance procedure	ii	Appointments/scheduling	2
Other*	25	Other	20	Other	nineteen

Reporters were also asked to specify "Bear on Level" on patients and their care: (a) unknown; (b) safety/environment (unsafe practices and/or conditions in the institution such equally a liquid spill, cleaved patient bed, etc.); (c) near miss (error/agin event corrected or averted earlier it reached the patient, east.m., a dosing mistake noted prior to administering medication); (d) no harm and no change in monitoring; (e) no harm simply monitoring initiated or increased; (f) temporary harm non requiring additional treatment; (chiliad) temporary harm, minimal treatment required; (h) temporary harm, major treatment/prolonged hospitalization required; (i) permanent harm; (j) life threatening (e.g., cardiac arrest, anaphylaxis); or (thousand) death. For the purposes of this study, nosotros differentiated between events that did not reach a patient (b and c, to a higher place) and those that did (d to g, above), which we designated "patient events." Nosotros further divided patient events into those that did not cause harm (d and e) and those that did (f to k), and defined the latter as adverse events. We grouped the 2 most severe injury categories, i and j, together because of small numbers. Figure 1 illustrates the nomenclature organization.

Data Analysis

All reports that occurred from January 1, 2001 through September xxx, 2003 were analyzed. Multiple reports of the same event were combined manually at each hospital site. All completed reports were placed in a single database for this analysis. Hospitals were deidentified to study investigators. Just amass analyses were performed and all reported events were analyzed, regardless of whether an error and/or adverse consequence occurred. Correlations between hospital characteristics (e.g., size, book) and reporting rates were performed using Spearman rank correlation coefficient. The data were analyzed and results interpreted past iii authors (C. One thousand., D. S., S. P.), none of whom had or have ties to commercial companies associated with medical events reporting systems. The commercial entity from which the data were obtained was not involved at any level in data assay or estimation of results, and did not provide fiscal back up for the study.

RESULTS

Reporting Rates

A total of 92,547 reports from 26 hospitals were evaluated over a total of 2,547,154 inpatient days. The hospitals ranged in size from 120 to 582 beds, had used the eastward-ERS from iii to 33 months (median 21), and contributed 674 to ix,617 reports (median 4,237). The range of reports per eligible 1,000 inpatient days (when the e-ERS was in use) was broad (nine to 95, median 35). There were no statistically pregnant correlations betwixt size of hospital or number of months of use of the eastward-ERS and reports per inpatient days. Virtually of the variability among the institutions occurred among institutions in which the eastward-ERS in apply for less than 24 months. Table 2 in the on-line Appendix shows reporting rates and infirmary characteristics for each of the hospital sites.

Of all reports, registered nurses reported 47%, pharmacists and pharmacy technicians xvi%, laboratory technicians 10%, unit clerks/secretarial staff 10%, licensed practical nurses and nursing assistants iii%, and physicians (including house staff) 1.four%. The remainder of reports was entered past a variety of employees including medical administration, doctor administration, physical therapists, security personnel, social workers, and risk and case managers.

Written report Classification

Of the total 92,547 reports, 34% were nonmedication-related clinical events, 33%medication/infusion events, 13%falls, 13%administrative events, and 6%other. Tabular array 1 shows rates for the most commonly reported events within each major category. Regarding touch level, the majority of reports, 53%, were events that reached a patient (patient events), xiv% were related to environmental condom, and 13% were almost misses. In 20% of reports, the touch on level on patients and patient intendance was unknown or not specified. In each of the impact levels, clinical and medication/infusion-related events together made upwards more threescore%, although their relative contributions varied (Fig. 2). For example, amidst all safety/surround events, one fifth were medication related, compared with nearly half among near miss events, and one third amidst patient events.

 Major categories of events within each touch on level.

Impact on Patients and Patient Care

Amidst the 49,341 patient events, 67% acquired no harm to patients. The remaining third caused injury: 32% temporary harm (of which 4% resulted in major handling), 0.8% permanent or life-threatening harm, and 0.four% contributed to death of a patient.

Across the levels of patient bear upon, the types of events varied, as shown in Fig. 3. For example, the relative proportion of nonmedication-related clinical events increased as severity of patient bear on increased, whereas the relative proportions of medication-related events decreased. The relative proportions of administrative-related events remained fairly constant beyond bear on levels, contributing approximately 10% in all categories, including 2 patient deaths.

Proportions of events past major category within Patient Event touch levels. This effigy represents impact levels within Patient Events but. Nomenclature every bit in text.

Overall, on average, 1 electronic report was generated every 28 patient-days; a patient event occurred every 52 patient-days, an agin patient event (harm to the patient) every 173 patient-days, and a life-threatening or permanent injury or death, every iv,303 patient-days. Estimated overall admissions, a patient consequence occurred in approximately 10% of admissions, an agin upshot in iii%, and life-threatening or permanent injury or death in 0.one%.

Give-and-take

Equally health care organizations increasingly focus on the monitoring of medical errors and adverse events, the utilise of voluntary reporting systems to detect, evaluate, and rails such events has increased. This report describes types and rates of voluntarily reported events in 26 astute care hospitals using an electronic reporting system. Nonmedication-related clinical and medication-related events each represented well-nigh a third of all reports. Events that reached a patient made up the majority of reports, of which two thirds caused no impairment to the patient and slightly over 1% resulted in permanent or life-threatening harm or death. Thirteen percent of reports were about misses that did not accomplish a patient and a similar percentage were environmental safe events. In this sample, a patient event occurred in approximately 10% of admissions, an agin upshot in three%, and life-threatening or permanent injury or expiry in 0.1%.

Our report represents "real-life" reporting past medical personnel of medical errors, adverse events, and near misses. No written report personnel were employed to prompt reporting or find deportment past infirmary staff, thus minimizing a "Hawthorne" effect because of written report participation. We are not enlightened of a study to date that has described the types and frequency of adverse events and errors voluntarily reported every bit role of routine infirmary operations.

Our study presents several of import aspects of using an due east-ERS in astute intendance hospitals. First, the rate of reports per i,000 inpatient days varied essentially among institutions and did not correlate with hospital size or duration of eastward-ERS use, although there was a trend toward less variation among hospitals that had used the e-ERS for two or more years. Thus, a steady country may be reached once credence and adoption of the e-ERS spreads throughout an establishment. Importantly, high reporting rates in an institution may not necessarily represent poor patient care, only rather an institutional culture that encourages reporting of errors and adverse events, integrates reporting into quality improvement processes, and focuses on organisation-level changes instead of individual blame and punitive actions.^ane

2d, the proportion of very serious adverse events, although small-scale, was not negligible: slightly more than than one per 1,000 admissions. If this rate is applied to the entire population of 33.7 million inpatients in nonfederal acute care hospitals in the U.S.,¹² an estimated 34,000 patients per year could be seriously or permanently injured or dice during hospitalization because of an adverse result.

Third, the e-ERS allowed for the reporting of a wide variety of dissimilar types and severities of agin events and errors, and did not only capture the most serious events. Nearly 70% of events that reached the patient produced no harm, and one quarter of all reports were either environmental safety issues or near misses. Thus, an e-ERS may be especially helpful in capturing system defects (latent errors) and almost misses that may not exist detected by reviews of patient charts or medication records. Importantly, analyses of such well-nigh misses may assistance identify "root causes" of errors and agin events.^{one , 3 , 6}

Finally, reporting rates reflect the reporters. Although the e-ERS was available and accessible to any infirmary employee and staff member, physicians contributed less than 2% of all reports. The variation in reporting rates between nurses and physicians may exist attributed to dissimilar definitions or perceptions of what constitutes an error or agin event, and, importantly, different training virtually and attitudes toward reporting them. Nurses, but non physicians, receive training in and are encouraged to report adverse events and complications arising from medical treatment.^xiii Physicians practise not receive education in the systematic evaluation of errors and adverse events, and thus operate within a conventionalities system of self-arraign and personal responsibility, rather than viewing such events as the end process of a series of systematic deficiencies. Additionally, physicians may not report because of "professional courtesy," concern for implicating colleagues, or fright of repercussions.^{one , fourteen}

It is difficult to compare the rates of events in our study to previously published ones primarily because of differences in data drove methods. Near published studies accept relied on retrospective chart reviews, or have been enquiry-based observational studies.^{4 – 6 , 15 – 17} Interestingly, the adverse event rate of 3% of admissions in our report is similar to the 3% to 4% rates reported in ii large medical tape reviews of hospital discharges, the Harvard Medical Do Report¹⁸ and a similar study in Colorado and Utah.¹⁹ Additionally, most studies have not relied on event reporting presumably because of low reporting rates. Studies of prompted reports of agin events by house staff have shown rates of 0.5% to 4% of admissions,^{10 , twenty , 21 , 22} and overall "quality issues," including near misses, in 10% of admissions.^{10 , 22} In 1 study, 2 hospitalists observed medical errors during routine patient care, finding an adverse event rate of 4% of admissions,²² again like to the 3% charge per unit in our study. In comparison, i written report found a reported adverse upshot rate of 0.04% using a traditional paper-based method.²³

In that location are several limitations of our written report. Despite the widespread availability of the e-ERS in each institution and accessibility to all hospital employees, it is likely that non all errors, agin events, or near misses were reported, and nosotros did non rely on alternative methods to identify such events. Additionally, reporting bias is likely, exemplified past the exceedingly low rate of reporting by physicians; bias in the types of events reported may also be.

Medical error and adverse result reporting rates are additionally influenced by institutional factors. The hospitals varied in size, geographic location, setting, academic affiliation, and number of months the east-ERS was in employ, and these factors may take contributed to the large differences in reporting rates across hospitals. Additionally, equally the e-ERS was implemented in each institution at different times, secular trends may besides have affected reporting of events. Furthermore, institutions likely differed regarding implementation and adoption of an east-ERS, and overall civilisation regarding the reporting and management of agin events and errors. Additionally, the agreement of processes that lead to medical errors and their systematic evaluation likely vary across hospital administrators and executive personnel. Thus, implementing any ERS requires training across the operational aspects to include education in the processes that pb to errors and agin events. We did non accept data on each establishment's efforts in adopting and training in the e-ERS, credence of the e-ERS among hospital personnel, or infirmary culture toward the reporting of errors and adverse events.

Despite these limitations, to our knowledge, this is the largest multihospital review of types of medical errors and agin events reported using a commercial e-ERS equally part of routine hospital operations. More inquiry is needed to determine whether an e-ERS increases the reporting of adverse events and errors and reduces their occurrences. In one large infirmary in the current study, employ of the e-ERS increased the overall reporting rate of adverse events and errors by nearly fourfold. Additionally, occurrences of repeated events were easily and expediently detected and a common cause and so identified (e.thousand., extravasation of parental nutrition associated with a process). Subsequent occurrences were tracked after changes in policy were instituted to decide their effects.

Thus, an e-ERS may aid overcome two of the roadblocks to improving prophylactic of medical care identified past Berwick.²⁴ First, by making errors and adverse events reporting accessible to all infirmary employees, besides as easy to review and track, they get more visible to clinicians, hospital administrators, government officials, and the public. Second, a reporting organization that allows for reporting of nigh misses and issues in the prophylactic of the hospital environment may assist uncover "root causes," such as some system errors, that may not exist identified by retrospective review. Additionally, a web-based east-ERS allows for existent-time upshot notification and oversight, and for concurrent tracking of rates over fourth dimension, tasks not hands performed with a paper-based organisation. Over the by two years, the National Patient Condom Agency in England has introduced a national system for identifying and reporting agin events in health care; in the absenteeism of such a national system in the U.South., infirmary-wide e-ER systems may exist important in the reporting, measuring, and tracking of agin events and medical errors.

Physicians should take a leading role in quality efforts to reduce medical errors and adverse events. The factors associated with the low reporting rates by physicians and in some hospitals require further evaluation.

Acknowledgments

Disclosures: Dr. Lundquist was formerly Chief Medical Officer of DrQuality Inc., an electronic medical error and adverse event reporting organization. Dr. Kumar is the Chief Medical Officer at Quantros Inc., and Mr. Chen is a statistician at Quantros Inc., which besides produces an electronic event reporting system.

Neither DrQuality nor Quantros provided financial back up for this written report or were involved in analysis or interpretation of results.

Supplementary Cloth

The following supplementary material is available for this article online:

Appendix

Examples of the reporting organization input screens and reports, and institutional reporting rates.

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