Medical Errors: Root Cause Analysis

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Health, Spirituality and Medical Ethics - Vol.2, No.2, Summer 2015

Improving Patients' Care through Electronic Medical Error Reporting System

Fatemeh Rangraz Jeddi1*, Fatemeh Atoof2 1 Associate professor of Health Information Management. Kashan University of Medical Sciences, Kashan, Iran

2 PhD Student. Tehran University of Medical Sciences. Tehran, Iran

[email protected] mail:-E. Fatemeh Rangraz Jeddihould be addressed SCorrespondence: *

Abstract

Background and Objectives: Medical errors are unintentional acts that take place due to the

negligence or lead to undesirable consequences in medical practice. The purpose of this study was

to design a conceptual model for medical error reporting system.

Methods: This applied descriptive cross-sectional research employed Delphi method carried out

from 2012 to 2013. The study population was medical and paramedical personnel of health workers

and paramedical personnel of hospitals, deputy of treatment, faculty members of Kashan University

of Medical Sciences in addition to the internet and library resources. Sample size included 30 expert

individuals in the field of medical errors. The one-stage stratified sampling procedure was used.

The items with opposition ranging 0 to 25 were confirmed and those exceeding 50 were rejected

whereas the items with the opposition 25 to 50 were reevaluated in the second session. This process

continued for three times and the items that failed to be approved were eliminated in the model.

Results: Based on the results of this research, repeated informing about and reporting operation

at on-line bases that have access to the incidence of error detected on time, identifying cause and

damage due to the incidence reported confidential and anonymously immediately after the

occurrence is necessary. Analysis of data quantitatively and qualitatively by using computer

software is needed. Classifying the errors reports based on feedback provision according to the

cause of error is needed. In addition, confidential report and possible manual retrieval were

suggested

Conclusion: It is essential to determine the means of reporting and items in the reporting form including

time, cause and damage of medical error, media of reporting and method of recording and analysis.

Keywords: design, informing, medical error, reporting,system.

Original Article Health, Spirituality and Medical Ethics. 2015;2(2):22-29

Please Cite This Article As: Rangraz Jeddi F, Atoof F. Improving Patients' Care through

Electronic Medical Error Reporting System. Health, Spirituality and Medical Ethics. 2015;2(2):22-

29.

Health standards are a set of procedures and acts

to ensure the regaining of patient's health. They

are logical acts and well-defined goals that are

mandatory to be followed by the practitioners

based on the condition and the accessible

facilities (1). The occurrence of medical errors

in extensive professions such as medical settings

is not unusual and the medical professionals

are always seeking means by which to avoid

Introduction

edical errors are unintentional acts that

occur due to the negligence or carelessness

which fail to lead to a desirable consequence in

medical practice. A medical error is defined as

the action made or decision taken in a health-

care setting that does not conform to the health

standards set in the field.

M

Improving Patients' Care through Electronic Medical Error

Health, Spirituality and Medical Ethics - Vol.2, No.2, Summer 2015

or reduce them. Since many cases of medical

errors are not reported, estimating an

approximate rate is very difficult (2). According

to the results of a research, 195000 deaths take

place every year due to medical errors (3).

The main cause of many medical errors is the

insufficient access to information at the time of

decision making and poor communication

among the caring team that usually work in

manually operating systems. Sedghiani has

indicated that one of the items in regard to the

evaluation of hospital is the inclusion of error

report form, its analysis and the result of such

report on the delivery of services (4). There are

many ways for reducing medical errors and

increasing the safety of patients (5). One of

them is discovering the errors through

employing a reporting system (6). A health care

system will benefit from discovering a medical

error only when there is a comprehensive

program and proper mechanism for analyzing

the condition under which the error took place

and then implement appropriate measure to

prevent its recurrence (7). Such a management

system requires understanding of the causes of

errors and introducing plans to prevent them

before they lead to harmful occurrences; a

system that will propose strategies and

guidelines to avoid the likely errors and dangers

that may occur in future.

Error reporting systems employ efficient

methods for eliminating errors in a health care

system. Error reporting may be committed

voluntarily or involuntarily. The voluntary

method of error reporting is done by physicians

and personnel within the medical centers who

are directly in contact with patients either para-

clinically or clinically. The involuntary

reporting is carried out according to the

assignment and duties defined by the health care

and medical service system (8). The result of

researches have indicated that systems that

employ voluntary and involuntary error

reporting method are more efficient and more

errors are reported by physicians so that that the

rate of reporting increases 20 times (10). The

importance of error reporting system is such that

many medical centers conduct error reporting

through their computer systems (11, 12).

A successful error reporting system must be

confidential and non-punitive. The analysis of

errors and reporting their explanation must be

performed by expert personnel who understand

the clinical cares and causes of error systems.

The report must be available on time. It must

rely on and emphasize the processes instead of

individuals; it must be capable of responding

appropriately to the needs of the system; employ

proper media and be accessible to the public. In

designing the medical error reporting system, it

is important to focus on systems, processes and

services instead of individuals. The system must

be able to provide the appropriate responses to

the beneficiary organization; it must be easy to

learn and use and release its result in a suitable

medium and be accessible to the public.

The design of medical error reporting system

must focus on important issues such as the

reporting of events, ease of using computer

technology and even web, evaluation of

effectiveness, and capability of executive

system review of goals, and obstacles in the use

of reporting system, procedures for

classification and reporting errors (8, 13. 14).

The purpose of this research was to design a

conceptual model for medical error reporting

system that has the capability of reducing the

medical errors and facilitating management

affairs.

Methods: This applied descriptive cross-sectional

research employed Delphi technique between

2012 to 2013. The study population was medical

and paramedical personnel. Sample size

included 30 expert individuals in the field of

medical errors. The means of determining

sample size was the one- stage stratified

sampling procedure. The experts were selected

from 5 categories including 3 physicians

(faculty members), 17 nurses, 2 midwifes, 7

paramedics and one manager. The selection was

based on the proportion of every profession.

The inclusion-exclusion criteria were based on

the involvement of the experts in the occurrence

of medical errors, who were working in the

offices of clinical governance or members of the

committees’ accreditation assessment of the

hospitals. The questionnaire was based on the

Rangraz Jeddi F, et al

Health, Spirituality and Medical Ethics - Vol.2, No.2, Summer 2015

library resources aligned with the research

objectives. The validity of the questionnaire

was confirmed through face and content

validity and question items were corrected

based upon opinions of 3 experts. To calculate

the reliability of the questionnaire, split-half

method was used and alpha level equal to 0.76

was calculated. The first draft of the

questionnaire was presented to the experts.

The item with opposition ranging 0 to 25 was

confirmed and those exceeding 50 were

rejected whereas the items with the opposition

between 25 to 50 were put forward to the next

step and reevaluated in the second session.

This process continued for three times and the

items that failed to be approved were

eliminated in the model.

Results

The result of analysis of data indicated that

informing the personnel about the reporting

medical error is a necessity. The main

components of the system are: a) recording the

event, b) analyzing and c) feedback and

reporting the result (figure 1).

In regard to the informing of reporting medical

error, the results showed that the highest

frequency of agreement among the expert in the

first stage of reporting was the written

informing form 29 (96.7%). In addition, written

informing method by matrons and educational

supervisor was deemed necessary while the use

of poster and brusher was suggested (table 1).

Data analysis also showed that implementing an

involuntary rule for recording the medical error

Table 1. Frequency Distribution of Expert Opinion regarding the Informing System

Opinion

Item

agree

Frequency

(percent)

disagree

frequency

(percent)

No opinion

frequency

(percent)

First stage

result

Second

stage result

Third

stage

result

method verbal 10 (33.3) 9 (30) 11 (36.7) reassessment remove *

written 24 (80) 1 (3.3) 5 (16.7) confirm * *

Person in

charge

matron 15 (50) 5 (16.7) 10 (33.3) reassessment confirm *

Educational

supervisor 18 (60) 2 (6.7) 10 (33.3) confirm * *

media

Internet 9 (30) 12 (40) 9 (30) reassessment remove *

journal 10 (33.3) 10 (33.3) 10 (33.3) reassessment reassessment remove

booklet 12 (40) 8 (26.7) 10 (33.3) reassessment reassessment remove

brochure 15 (50) 7 (23.3) 8 (26.7) confirm * *

poster 14 (46.7) 11 (36.7) 5 (16.7) reassessment confirm *

television 8 (26.7) 13 (43.3) 9 (30) remove * *

satellite 2 (6.7) 16 (50.3) 12 (40) remove * *

characteristics

Repeated

informing 22 (73.3) 6 (20) 2 (6.7) confirm * *

Overall

reporting in

hospital

29 (96.7) 1 (3.3) 0 (0) confirm * *

* did not enter at this stage

Improving Patients' Care through Electronic Medical Error

Health, Spirituality and Medical Ethics - Vol.2, No.2, Summer 2015

while keeping the reporter animosity and the

report confidentially immediately after the

incidence is desirable. In addition, rewarding

the reporter in addition to having a simple and

comprehensible method appropriate for the

objectives to improve the care and services of

health care were confirmed. Moreover,

recording the time of incidence, cause and harm

inflicted and the title of the person committing

the error were also suggested. The result of

analysis showed that using electronic and on-

line media was necessary. According to experts'

beliefs, the medical errors must be analyzed and

the cause be identified.

In their opinion, quantitative and qualitative

analysis using software, statisticians' and

experts' views on medical errors is

indispensable. All the experts (30, 100%) in the

first stage suggested the need to analyze the

medical errors. The lowest frequency of

agreement was about the necessity to perform

analysis by the medical record expert (14,

46.7%). The highest frequency of agreement

among experts in the first stage was verbal

feedback (29, 96.7%) (table 3).

With regard to the feedback provision and

effectiveness of reporting the result of analysis

of medical errors for reducing the errors, the

need for classification based on the type of error

and maintaining the confidentiality was

emphasized by the experts (table 4).

Discussion:

A medical system of reporting the medical

errors demonstrates the performance and

capability of the hospitals or other health care

centers for presenting the cares based on the

safety standards (15-18). Despite the fact that

voluntary reporting of medical errors leads to

under reporting of the real cases of errors which

in turn is considered as weakness in the system

(19), nowadays such an act plays an important

role in reporting the errors and increasing the

safety of patient on one hand and on the other

hand leads to the development and improvement

of the system to reduce medical errors. For these

purposes, different methods of medical error

reporting are used in many countries (20-21).

The results of the present research showed that

repeated error reporting, particularly, written

Table 2. Frequency Distribution of Expert Opinions about the Recording of the Events Third

stage

result

Second

stage

result

First stage

result

No opinion

frequency

(percent)

Disagree

Frequency

(percent)

Agree

frequency

(percent)

Opinion

Item

* * remove 4 (13.3) 14 (46.7) 12 (40) Arbitrary recording the error

R eco

rd in

g M

eth o d

confirm reassessment reassessment 9 (30) 5 (16.7) 16 (50.3) Compulsory reporting the error

* confirm reassessment 9 (30) 6 (20) 5 (16.7) Animosity of the reporter of error

* * remove 9 (30) 13 (43.3) 8 (26.7) Known reporter of error

* confirm reassessment 5 (16.7) 3 (10) 22 (73.3) Confidentiality of the error

recorded

confirm reassessm

ent reassessment 5 (16.7) 7 (23.3) 18 (60)

Recording the error by the

committer

* * confirm 4 (13.3) 0 (0) 26 (86.7) Recording immediately after the

incidence

confirm reassessment reassessment 11(36.7) 2 (6.7) 17 (56.7) Rewarding the error recorder C h

aracteristic o f

reco rd

in g

th e

ev en

ts * * remove 9 (30) 18 (60) 3 (10) Punishing the error recorder

* * confirm 1 (3.3) 1 (3.3) 28 (93.3) Plain design

* * confirm 1 (3.3) 1 (3.3) 28 (93.3) Clear design

* * confirm 0(0) 0 (0) 30 (100) Comprehendible design

* * confirm 0 (0) 0 (0) 30 (100) In line with the goals of care and

control

* * confirm 0 (0) 2 (6.7) 28 (93.3) Recording the time of error A t least o

f

elem en

ts

* reassessm

ent reassessment 4 (13.3) 4 (13.3) 22 (73.3)

Recording the responsibility of

the reported

* * confirm 0 (0) 0 (0) 30 (100) Recording the cause

* * Confirm 0 (0) 1 (3.3) 29 (96.7) Recording the damage due to error

* confirm Reassessment 3 (10) 6 (20) 21 (70) Internet m ed

ia

* * confirm 4 (13.3) 10 (33.3) 16 (50.3) electronic

* * confirm 2 (6.7) 5 (16.7) 23 (76.7) Hospital information system

Rangraz Jeddi F, et al

Health, Spirituality and Medical Ethics - Vol.2, No.2, Summer 2015

ones by the matrons and educational supervisors

is necessary. While the use of posters and

brochures are also suggested for this purpose .

Jerico suggested the use of educational

intervention program to increase the incidence

of medical error reports (22). The result of a

study conducted in an educational hospital

indicated that 54.8 percent of the physicians

knew the method of reporting medical errors

and only 39.5 percent of them were familiar

with what errors need to be reported (23). In

another study, 98 percent of the health workers

were aware of the reporting system while 25

percent knew how to use these reports (24).

Mcneil et al. reported that 71 percent of the

medical workers were familiar with the system

of error reporting (25). White et al. indicated

that only 31 percent of the intern and resident

students received instruction about how to

complete an error reporting form (26). All these

evidence show that reporting the medical errors

is necessary and must be consistently

performed.

The present research emphasized that recording

the errors has to be obligatory, anonymous and

confidential. It should also be done immediately

after the incidence along with rewarding the

reporter. Simple and comprehensible design,

recording the time and cause of the harm in

addition to the status of person committing the

error were confirmed as the minimum measures

of recording .

This is similar to the results of investigators that

claimed the medical error reports must be

confidential with no punishment consequences

and unrelated to the authorities exercising

punishing act in addition to being simple and

comprehensible and provide the opportunity to

report the incidence (7, 8, 17, 27, 28). These

systems need to be designed in a way that

maintains the identity of the reporter

anonymously and keeps the records

confidentially (27, 29). In addition, the

information related to the incident should

include the cause of error, the harm inflicted and

the reason for the occurrence (8, 27). Some of

studies in this regard suggest other information

such as the date of incidence and reception of

report, ward of the hospital where the event took

place and the severity of incident is recorded

Table 3. Frequency Distribution of Expert Opinion about the Analysis of Medical Errors

Opinion

Item

Agree

Number (%) Disagree

Number (%) No opinion

Number (%) Result of first stage

Need to analyze 29 (96.7) 1 (3.3) 0 (0) confirm

Cases examined cause 30 (100) 0 (0) 0 (0) confirm

Reason of recurrence 29 (96.7) 0 (0) 1 (3.3) confirm

Type of analysis quantitative 19 (63.3) 4 (13.3) 7 (23.3) confirm

qualitative 26 (86.7) 1 (3.3) 3 (10) confirm

analyzer

Statistical software 21 (70) 3 (10) 6 (20) confirm

statistician 17 (56.7) 4 (13.3) 9 (30) confirm

Medical record expert 14 (46.7) 6 (20) 10 (33.3) remove

Hospital's matron 16 (53.3) 5 (16.7) 9 (30) confirm

Expert of medical error 29 (96.7) 0 (0) 1 (3.3) confirm * did not have second and third stage

Table 4. Frequency Distribution of Expert Opinion about the Feedback and Reporting the Result of Analysis of Medical Errors

Opinion

Item

Agree

Number (%) Disagree

Number (%) No opinion

Number (%) Result of

first stage

Goal Error reduction 27 (90) 2 (6.7) 1 (3.3) confirm

Classifying errors 27 (90) 0 (0) 3 (10) confirm

Method of maintaining confidential 24 (80) 1 (3.3) 5 (16.7) confirm

Non-confidential 4 (13.3) 18 (60) 8 (26.7) remove

Retrieval method Non-electronic 17 (56.7) 2 (6.7) 11 (36.7) confirm

electronically 6 (20) 20 (66.7) 4 (13.3) remove

Feedback results verbal 29 (96.7) 0 (0) 1 (3.3) confirm

written 27 (90) 0 (0) 3 (10) confirm * did not have second and third stage

Improving Patients' Care through Electronic Medical Error

Health, Spirituality and Medical Ethics - Vol.2, No.2, Summer 2015

(19). Moreover, there are research reports that

suggest punishing measure and promoting the

culture are effective means of the success of

reporting errors (7, 27).

However, recording time and the harms induced

due to the commitment of error have been

repeatedly listed (28, 30). Despite the fact that

different research results have named different

factors, it seems that recording the time, causes

of harm and consequences of the medical errors

are important factors in reporting the errors .

In addition, based on the results of the present

research, the use of electronic media on-line and

accessibility seems necessary. These results are

in agreement with the results of research

reported by Waangler et al. (5) and Bizely et al.

(30), Vomhendler et al. (28) and Pearson and et

al. (31) who employed a reporting system based

on Web access. Considering the development of

technology and its application, it is suggested to

employ electronic systems for improving the

treatment cares. With respect to the analysis, the

expert has emphasized the use of quantitative

and qualitative analysis, identifying the causes

and use of software by statisticians. In addition,

it was indicated that matrons and experts in

medical error should evaluate the reports in

order to reduce the errors. Verbal and written

feedback in addition to the use of electronic

media feedback was also emphasized .

In many countries, error-reporting systems to

record medical errors and provide feedback for

the purpose of reducing or eliminating the errors

have been installed (17, 19, 32, 33, 34). Since

the number of medical errors is on the rise and

the presence of error detecting and reporting

system provides the facility to identify and

evaluate the clinical errors (35), the

accumulated data must be compared instantly

with the national and local data and reported to

the responsible authorities (28) and feedback

must be provided for the clinical mangers, heath

service providers and even the patients (27). In

a study conducted by Evans, 65 percent of the

participants believed that lack of feedback is the

biggest barrier in the reporting system and acts

as an obstacle that reduces the effectiveness of

these systems (24). The creation of a web site

has been proposed as a means of sharing results

experienced by medical error (26).

Despite the fact the separating the error system

from the governmental services has a significant

effect on the successful operation of the system

(29) and gives it an independent system of

reporting that has been noticed on many

occasions, reporting the results of data analysis

by experts and statisticians anonymously to the

authorities is necessary (8).

It is suggested that a supervising team of experts

on medical error be formed in every health and

treatment center for the purpose of consistent ,

accurate and on-time follow –up and entire data

analysis to examine and evaluate the causes of

medical errors occurring in the health and

treatment centers.

Conclusion:

Providing information and education are the

first steps for correct recording of medical errors

and improvement of treatment services.

Electronic media, particularly, on-line access

from different locations was suggested as the

preferred medium. In addition, analysis and

feedback provision were suggested as

inseparable parts of a system designed to control

errors.

Acknowledgements: Vice Chancellor for Research of Kashan

University of Medical Sciences is highly

appreciated for financial support for carrying

out the present study (Project No.9111) and

also, we would like to thank all participants in

the collaborative project.

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