Each quality improvement (QI) initiative is composed of systematic inputs, processes, and activities. Additionally, the QI initiative is a team process involving various st

Ori gi nal Ar tic le

21

©Copyright 2018 by Ege University Faculty of Medicine, Department of Pediatrics and Ege Children’s Foundation

The Journal of Pediatric Research, published by Galenos Publishing House.

Ad dress for Cor res pon den ce Hojjat Sheikhbardsiri PhD, Kerman University of Medical Sciences, Department of Emergency Operation Center, Disasters and Emergencies Management

Center, Kerman, Iran Phone: +98 913 279 31 99 E-mail: [email protected] ORCID ID: orcid.org/0000-0002-3264-6792 Re cei ved: 17.08.2017 Ac cep ted: 02.11.2017

1Isfahan University of Medical Sciences, Health Management and Economics Research Center, Faculty of Management and Medical Informatics, Isfahan, Iran 2Kerman University of Medical Sciences Hospital Afzalipour, Master of Science in Nursing Orientation Ward Nicu, Kerman, Iran 3Kerman University of Medical Sciences Research Center for Health Services Management, Institute for Future Studies in Health, Kerman, Iran 4Kerman University of Medical Sciences, Department of Emergency Operation Center, Disasters and Emergencies Management Center, Kerman, Iran

Yasamin Molavi-Taleghani1, Asma Abdollhayar2, Mahmoud Nekoei-Moghadam3, Hojjat Sheikhbardsiri4

Introduction

Medical failure poses a real threat to both the health system and the patients’ health. It is likely to happen in all diagnosis and treatment stages, which is often costly and reduces the quality of life of patients (1). Hence, maintaining

patient safety is a major concern in the health care system (2). Furthermore, the Emergency Department is one of the most challenging departments of the hospital for for the study of patient safety because of its unique features (3). In emergency situations, time for critical thinking, which results in delays in decision making and consequently an increase

ABS TRACT Aim: The Emergency Department is one of the most challenging wards of the hospital for studying patient safety and the prevention of treatment errors is the basic rule in the quality of health care. The present study was conducted to evaluate the selected risk processes of Pediatric Emergency of Qaem Educational Hospital in Mashhad by the Healthcare Failure Mode and Effects Analysis (HFMEA) methodology. Materials and Methods: A mixed method was used to analyze failure modes and their effects with HFMEA. Five high-risk processes of the Pediatric Emergency were identified and analyzed. To classify failure modes, nursing errors in clinical management model; for classifying factors affecting error, the approved model by the United Kingdom National Health System; and for determining solutions for improvement, Theory of Inventive Problem Solving was used. Results: In 5 selected processes, 28 steps, 80 sub-processes and 254 potential failure modes were identified with HFMEA. Thirty-seven (14.5%) failure modes as high-risk errors were detected and transferred to the decision tree. The most and the least failure modes were placed in the categories of care errors as 62.3%, and knowledge and skill as 8.1% respectively. Also, 23.6% of preventive measures were in the category of human resource management strategy. Conclusion: Using the proactive method of HFMEA for identifying the possible failure of treatment procedures, determining the effective cause on each failure mode and proposing the improvement strategies, has high efficiency and effectiveness. Keywords: Emergency, Healthcare Failure Mode and Effects Analysis, pediatric, risk management.

Practical Aspects of the Use of Healthcare Failure Mode and Effects Analysis Tool in The Risk Management of Pediatric Emergency Department: The Scrutiny in Iran

J Pediatr Res 2018;5(1):21-31 DO I: 10.4274/jpr.78300

Oriﾭgiﾭnal Arﾭticﾭle

ﾩCopyright 2018 by Ege University Faculty of Medicine, Department of Pediatrics and Ege Children�s Foundation The Journal of Pediatric Research, published by Galenos Publishing House.

22

in adverse events, is very short (3). Preventable errors are one of the main factors of patient death and disability. Based on the results of a study, nearly 40% of inpatients have become disabled, and 2.3% of these disabilities were related to preventable errors (4). Totally, 3% of all hospital errors are related to the emergency department (5). Furthermore, approximately one-third of the patients referring to hospitals are for the pediatric emergency department, and this department has been identified as a high-risk area in the health care system (6). Adverse events have resulted in an extra expenditure of about 37 billion US dollars in America, and one to two billion pounds in England (7). Prevention of medical errors is one of the basic principles in the quality of health care (7). In all quality improvement programs, an error prevention and risk management approach is one of the pivotal aspects of creating, establishing, and deploying management systems in organizations (8). One of the most promising risk prevention programs from the viewpoint of the National Center for Patient Safety (NCPS) and the US Accreditation Commission, is Healthcare Failure Mode and Effects Analysis (HFMEA) (9). In fact, HFMA is a systematic and predictive strategy which is designed specifically for healthcare organizations to identify and prevent errors before they happen (10). This method is used extensively in order to identify errors and improve patient safety standards. Results of studies indicate that from 2008 to 2009, and after the implementation of risk assessment programs by NCPS, the number of adverse medical events has reduced from 3643 to 2412 (11). The administration of patient safety plans in the Emergency Department has improved the quality of healthcare and patient satisfaction (12), and the Emergency Department is one of the most important departments of the hospital (13), as well as being the first department to provide healthcare for many patients (14). Therefore, the present study was conducted to evaluate the selected risk processes of pediatric emergency of a treatment-educational Qaem center in Mashhad by the HFMEA methodology.

Materials and Methods

Research Design and Setting

This study was approved by the ethical committee of Mashhad University of Medical Sciences prior to the collection of the data in January 2013 (approval number: 911089). Written informed consent was recruited from each participant. A mixed-method including qualitative action research and descriptive quantitative cross-sectional study was conducted in 2016. Qaem Hospital is ranked as one of the largest educational and therapeutic centers at regional and national levels, with a total of 870 active beds, 18 units and 7 emergency rooms, with Para clinical services and clinics. Children’s Emergency Department of Qaem Hospital undertakes the following services: reception and outpatient treatment; performing, sending and following-up

laboratory tests; serum attachment; physiotherapy; tension test; catheterization; electroencephalogram; performing, sending and following the response of the cerebrospinal fluid; vaccination, washing, wound dressing of the patient; patient’s initial visit, nominal group technique, electromyography-nerve conduction velocity, magnetic resonance imaging (MRI), computed tomography scan; neonatal lactation; endoscopy; liver biopsy; primary visit; patient radiology, Sonography, suction, intubation, auditory test, optometry test, delivery of blood transfusion and blood products, phototherapy and determining the condition of the patient (transferring the patient to other departments for continued care or discharge). In this study five high-risk processes of pediatric emergency department were identified and analyzed in Qaem Treatment- Educational Center. It should be noted that the temporary admission rate in the Pediatric Emergency had an average of 396 people per month (200 temporary admissions in the morning shift, 110 admissions in the evening shift and 86 in the night shift) in 2015.

Data Collection

Data gathering was done through focus groups, interviews, observation, and brainstorming. The validity of this study was controlled by the consensus of team members at the end of each phase. The stages of this research were determined according to the five stages of the analysis of the states and effects of health care errors by the National Center for Patient Safety (9), and were carried out as follows, which, as the circumstances require, have differences with the proposed model;

Step 1: Choosing a Risky Process

Via the “voting method using rating” technique, ten members of the pediatric emergency department were asked to rank five of the 26 processes listed in the section, considering the problem effects on the patients’ dissatisfaction, the likelihood of injuries by the problems and the need to fix the problems. Then, the data obtained from the voting was finalized according to the matrix or the Breda function and five priority processes were selected for risk management (15,16).

Step 2: Assembling the Team

Qaem Hospital’s emergency staff includes a supervisor, 8 nurses, 3 staff members, one children’s emergency department director, 5 pediatricians, a secretary, two crew members and 6 pediatric residents. In the staffing program, the staffing of the emergency medical staff is carried out three times morning, evening and night. In this process, 15 persons participated as the members of HFMEA team, including the responsible person of risk management (team leader), an expert in health services (team advisor), an assistant professor in the emergency department, head of the emergency department, a supervisor, two assistants

Molavi-Taleghani et al. Risk Assessment of the Pediatric Emergency Department

23

(residents), two nurses, the chief of the laboratory, a laboratory expert, a blood bank expert, MRI expert, and head of the MRI department.

Step 3: Graphically Describing the Processes

At this stage, the charts of the selected processes and their sub-processes were drawn through the observation and individual interviewing method, and the accuracy of the diagram of the flow of processes and sub-processes was modified and approved by the team members in a group discussion session, and was drawn in the form of a process flowchart with Visio software.

Step 4: Conducting Hazard Analysis that Took Place in Four Phases

First phase: Determination of potential failure modes At this stage, the error states of each of the sub-

processes of the selected sections were identified by the triangular method (17), and classified according to the classes of the “Nursing Error Management Association” model (18). Failure modes according to the nursing errors in clinical management model were categorized in 4 main groups of communication; care process, administrative, knowledge, and skilled based error (18).

Second Phase: Determination of the hazard score The hazard Score was determined using the Error Scoring

Matrix (the product of the two elements of the severity and probability of occurrence of the error) and was recorded in the HFMEA worksheet. The errors were grouped according to their hazard score into four intervention levels, i.e., emergency, urgency, programming, and monitoring (Table I) (19).

Third Phase: Designing decision making tree The non-acceptable risks (risk score level more than

8) were transferred to the decision tree. Decisions for proceeding or stopping each of the failure modes was made based on three items; weakness points, existing control, and detectability.

Fourth Phase: In this phase, the failure mode causes of each failure mode, and where the decision is to “Proceed” were categorized into 9 root causes in the consultative cause-effect meetings, and in the format of an approved model by the UK National Health System (20).

Step 5: Actions and Measurement of Consequences which Were Performed in Two Phases

Phase 1: Definition of Error Control Strategies In this phase, suggested coping strategies were proposed

for the causes of errors in the decision tree in the form of acceptance, control, and elimination of errors. The second phase, redesigning the process: improving strategies for each cause of error with a score ≥8 in the team meetings through “theory of the problem solving by an inventive method” (21,22) were provided and classified with inspiring by the proposed model of “classification of preventive strategies in the incidence of medical errors” (7,23), and finally decisions were made about the practicability of the implementation of any approach with regard to the resources of the organization.

Statistical Analysis

Quantitative Analysis: For the quantitative analysis of the variables related to the failure mode analysis phase, descriptive statistics were calculated in Excel software, including frequency, percent, and mean. Also, for the quantitative analysis and determination of the probability of the failures, the sum of the team’s scores was used with consideration of a coefficient for each team member. For the severity of the failures, the team members’ consensus along with the consideration of weight for the severity of failures was used. In the final worksheet, we calculated and documented the sum of the failure mode severity scores according to team members’ opinions. By considering weights for the failure mode severity dimensions we calculated the sum of the failure mode probability scores based on the involved personnel’s opinions (also by considering the coefficient for each person).

Qualitative Analysis: Content analysis was done on the data collected from the individual interviews in order to put them in the organized forms. To do so, all the interviews with the team members were transcribed, and, for the sake of understanding the transcriptions, they were read, and repetitions were omitted and the significant issues were extracted. Therefore, a list of all of the team members’ opinions was prepared. Analysis of the data from the brainstorming, cause and effect, and problem-solving sessions was done based on the general agreement of the team members. It should be noted that the time taken to carry out the study was 38 hours.

Results

By voting method using rating, 5 out of 20 identified processes in pediatric emergency, with Borda number of (37 score) for the process of MRI implementation (32 score) for the process of performing, sending and tracking the laboratory results (25 score) for the process of implementing the lP (18 score) for transferring CSF specimen and following up the results and (7 score) for the process of setup IV line, were chosen. According to the results, for 5 selected processes per 28 listed steps, 80 sub-processes and 254 failure modes were identified. According to table 2, the interventional levels showed that 1.2% of the error modes

Molavi-Taleghani et al. Risk Assessment of the Pediatric Emergency Department

Table I. Error scoring matrix and classification of interventional levels

Intervention level

Severity& probability

Catastrophic (4)

Important (3)

Intermediate (2)

Minor (1)

Emergency Usual (4) 16 12 8 4

Urgent Sometimes (3)

12 9 6 3

Programming Unusual (2) 8 6 4 2

Monitoring Rare (1) 4 3 2 1

24

Molavi-Taleghani et al. Risk Assessment of the Pediatric Emergency Department

Table II. Frequency distribution of failure modes in each area of the error scoring matrix and classification of failure modes based on the model of Management Association of nursing error for the selected emergency pediatric processes

H ig

h- ri

sk p

ro ce

ss es

o f

em er

ge nc

y pe

di at

ri c

Activities

N um

be r

of su

b- pr

oc es

se s

N um

be r

of fa

ilu re

m od

es

M ax

im um

h az

ar d

sc or

e

M in

im um

h az

ar d

sc or

e

Number of intervention levels categories

Frequency percentage of failure modes based on association model of “management of nursing error”

Em er

ge nc

y le

ve ls

U rg

en t l

ev el

s

Pr og

ra m

in g

le ve

ls

M on

ito ri

ng

le ve

ls

Ca re

p ro

ce ss

er

ro r

Co m

m un

ic at

io n

er ro

rs

Ad m

in is

tr at

iv e

er ro

rs

Kn ow

le dg

e an

d sk

ill e

rr or

s

A dm

in is

tr at

io n

of la

b te

st s,

tr

an sf

er rin

g an

d fo

llo w

u p

Order for lab test 6 19 9 2 0 3 14 2 17 7 0 1

Sampling and transferring the sample

4 17 9 3 0 1 15 1 13 2 5 4

Sample analysis 4 15 9 6 0 2 13 0 14 0 6 2

Preparing test results 1 4 9 6 0 3 1 0 4 0 2 0

Reporting the test result to the doctor

2 5 6 4 0 0 5 0 4 0 0 1

M RI

Order for MRI 2 7 9 4 0 2 5 0 5 1 0 1

Informing the ward secretary about MRI order

3 11 9 2 0 1 8 2 4 3 1 2

Reporting MRI order to MRI ward 3 8 6 4 0 0 8 0 3 5 2 0

Transferring the patient to MRI ward

2 8 6 4 0 0 8 0 9 0 1 0

MRI implementation 1 4 9 2 0 1 2 1 3 0 2 0

Taking results and reporting that to the doctor

2 5 6 2 0 0 3 2 5 0 1 1

Tr an

sf us

io n

Doctor order for blood transfusion and checking doctor order

3 10 9 4 0 2 8 0 7 1 5 1

Sampling 4 13 6 3 0 1 10 2 12 3 2 1

Administration of required tests before transfusion

5 14 12 3 2 3 9 0 8 3 4 0

Requesting blood from blood bank by pediatrics emergency ward

3 10 12 4 1 2 7 0 7 1 1 0

Reception of blood from blood bank by pediatrics emergency ward

2 4 6 4 0 0 4 0 3 0 1 0

Implementing required actions before transfusion

3 13 8 4 0 2 11 0 9 3 1 0

Starting blood transfusion 2 7 8 4 0 2 5 0 5 3 0 0

Recording transfusion in the patient file

2 6 9 4 0 1 5 0 0 4 1 0

Im pl

em en

tin g

LP , t

ra ns

fe rr

in g

CS F

sp ec

im en

a nd

fo llo

w in

g up

th e

re su

lts

Doctor order for LP 2 8 9 3 0 2 4 2 8 2 2 0

Preparing equipment and administrating LP

4 14 9 2 0 3 5 6 15 3 2 2

Preparing and transferring CSF specimen to the lab

3 8 6 4 0 0 8 0 3 0 6 0

Preparing results by the lab 3 9 9 4 0 2 7 0 8 0 3 1

Transferring result to the doctor, interpretation of the results and starting action based on the result

2 3 6 4 0 0 3 0 3 0 1 1

25

Molavi-Taleghani et al. Risk Assessment of the Pediatric Emergency Department

were related to the emergency levels intervention, 13.3% to urgent, 76.3% to programmed, and 9.1% were related to the monitoring area. Also, the number of identified failure modes, the number of intervention levels and the classification of the failure modes for the selected processes based on the proposed model were shown by the association of “management of nursing error”. According to Table II, (62.3%) of the failure modes related to care process error; (13.8%) to communication errors; (15.7%) to administrative errors; and (8.1%) to knowledge and skill errors. In the next step, from the 254 detected failure modes, 37 (14.5%) were recognized as high-risk and unacceptable (hazard score of 8 and higher) and were transferred to the decision tree (Table III). In Table III, classification of the causes of high-risk and non-acceptable risk (hazard score ≥8) is shown based on an approved model by the UK National Health System. According to table 3, among the 106 effective causes detected in the high-risk failure modes of the decision tree, 9.4% related to team factors; 7.5% to organizational factors; 12.2% to communication factors; 7.5% to task factors; 12.2% to personnel factors; 16.1% to environment factors; 9.4% to patient factors; 18.8% to education factors,

and 6.6% to facilities and technologies. Table IV, Phase I, Definition of Error Control Strategies: In this phase, suggested coping strategies were proposed for the causes of errors in the decision tree in the form of acceptance, control, and elimination of errors. Strategies suggested opposing the contributing factors to each failure mode were presented in the forms of acceptance (25%), control (58.3%), and elimination (16.6%). In Table V, the strategic classification and preventive approaches proposed by the problem-solving theory are shown based on the proposed model. According to Table V, among the 106 strategies detected in the high- risk failure modes of the decision tree, 23.6% related to human resource management; 2.9% to the installation of electronic prescribing system; 5.9% related to making people accountable for patient’s safety; 5.9% related to medical equipment management and process standardization; 4.1% to the improvement of the patient identification process; 2.6% related to making clear and transparent policies and procedures; 3.2% to making sure of the availability of a suitable technology for quality improvement; 7.6% to the continuous training and briefing of care providers at the beginning of employment; 11.2% related to the participation

Table II. Continue

IV li

ne s

et up

Checking for doctor order 2 4 4 4 0 0 4 0 3 1 1 0

Preparing IV set 4 9 9 4 0 1 8 0 10 2 1 2

Setting up IV line 4 12 6 2 0 0 9 3 12 2 1 5

Patient observation and recording IV line setup

2 7 4 2 0 0 5 2 8 2 0 0

Total 80 254 214 98 3 34 194 23 202 45 51 26

Hint: It may put failure modes in different categories based on management association of nursing error, CSF: Cerebrospinal fluid, LP: Lumbar puncture, MRI: Magnetic resonance imaging, IV: Intravenous

Table III. Classification of the basic causes of failure modes with error score ≥8 based on Eindhoven model

Error cause Setup IV line Laboratory management

Delivery, transfusion of blood and blood products

MRI implementation Implementing LP, transferring CSF specimen and following up the results

Total root causes based on effective factors

Factors related to patient and patient caregiver

1 1 1 1 6 10

Factors related to personnel 0 3 6 2 2 13

Task factors 0 2 6 0 0 8

Communication factors 1 4 3 3 2 13

Equipment factors 0 3 3 0 1 7

Environmental factors 0 6 8 1 2 17

Organization factors 0 2 3 2 1 8

Educational factors 1 6 7 1 5 20

Team factors 1 2 4 2 1 10

Total root causes based on the process

4 29 41 12 20 106

CSF: Cerebrospinal fluid, LP: Lumbar puncture, MRI: Magnetic resonance imaging IV: Intravenous

26

Molavi-Taleghani et al. Risk Assessment of the Pediatric Emergency Department

Table IV. The worksheet of failure modes techniques and Healthcare Failure Mode and Effects Analysis for some high-risk failure modes of the selected pediatric emergency processes

Action and outcome measuresHazard analysis

Actions or rationale for stopping

Ac tio

n ty

pe

Pr oc

ee d

Decision tree analysisScoringPotential causesFailure mode

D et

es ta

bi lit

y

Ex is

tin g

co nt

ro l

m ea

su re

s

W ea

kn es

s po

in t

H az

ar d

sc or

e

O cc

ur re

nc e

Se ve

ri ty

YesNoNo1243Slip in checking the blood request form by the blood bank while delivering the blood bag

1) Stress management and tasks distribution

ANo–no623A) temporal high work load of blood bank

1) Developing the staff performance evaluation scales, based on the mistake that occurred 2) Annual evaluation of personnel of appropriate blood transfusion process 3) Training physicians about the “right patients, right time and right blood” guideline 4) Training on compliance with accreditation requirements 5) Root cause analysis about catastrophic events and giving feed back to the blood bank

CYesNoNo933B) Lack of awarness of importance of the issue and necessary evaluation by the blood bank

1) Training on and implementation of principles of registering reports and request form 2) Rejecting the unreadable form by the blood bank

ENoYesNo632C) Lack of readability of request form

YesNoNo933Ask the patient for MRI request Healthcare team collaboration-review

of inter ward transfer policy-constant observation of head of the ward on ward and during patient transfer

CYesNoNo933A) MRI cancellation and not implementing it

Using PACS system-informing the doctors about the results

ENo-Yes313B) Not knowing about the results

YesNoNo1243Delay in initiation of testing the samples in laboratory

1) Reducing the workload and creating shift table and preventing successive shifts 2) Providing extra work force 3) Fitting the workload with number of human forces 4) Coordinating the treatment team and establishing stress management

ANoYesNo12431) Crowded laboratory

1) Holding briefing sessions at the beginning 2) Appoint a leader or head for the team 3) Sharing the information with treatment team

CYesNoNo9332) Lack of awareness of importance of the issue

1) Periodic monitoring and evaluation of laboratory ward 2) Checking the competence of team leader or the responsible person 3) Monitoring temporal sequence of process

CYesNoNo9333) Lack of supervision of technical manager on procedures

Arrow pointing to the right

Arrow pointing to the right Arrow pointing to the right

Arrow pointing to the right

Arrow pointing to the right

Arrow pointing to the right

Arrow pointing to the rightArrow pointing to the right

Arrow pointing to the right

Arrow pointing to the right

Arrow pointing to the right

Arrow pointing to the right

Arrow pointing to the right

27

Molavi-Taleghani et al. Risk Assessment of the Pediatric Emergency Department

Table IV. Continue

YesNoNo933Lack of patient cooperation during sampling

1) Increasing patient knowledge by effective communication and patient participation 2) Assessing patient communication ability with healthcare provider 3) Providing patient with information

AYesNoNo12431) Patients fear specially children from medical procedures

1) Providing patient with information and consequences of procedures 2) Administrating topical anesthesia before LP

CYesNoNo9332) Lack of right communicat-ion between patient and healthcare providers

YesNoNo933Desterilizing of IV set by patient caregiver 1) Informing patient caregiver about the

type of the procedure 2) Informing patient about consequences of each procedure 3) Advising patient not to interfere in the care process

CYesNoNo6231) Lack of patient caregiver knowledge

1) Holding teamwork training workshops for all team members 2) Devising Plans for patient safety 3) Cooperation of healthcare team

CYesNoNo6232) Lack of medical team observation on ward

Hint E: Elimination, C: Control; A: Accept MRI: Magnetic resonance imaging, PACS: Picture archiving communication systems, IV: Intravenous, LP: Lumbar puncture

Table V. Classification of strategies and preventive measures for causes of high risk error modes (risk score ≥8)

Ward Strategy classification

Improvement strategy by means of the TRIZ method In

tr av

en ou

s

Bl oo

d an

d bl

oo d

pr od

uc ts

tr

an sf

us io

n

M R

I

La bo

ra to

ry

m an

ag em

en t

LP To ta

l

Human resources management

Determination of a supervisor for treatment team, evaluation of the competency of team leader, conducting periodical assessment and offering feedback to the personnel, giving treatment team the necessary information, defining the responsibilities and announcing them, reducing the work load and correcting the lack of work forces, continuous supervision and controlling the performance procedures and adjusting the workload with staff

1 30 7 32 10 80

Installation of electronic prescribing system

Implementation procedure on drug combination 0 0 0 1 0 1

Making people accountable for patient’s safety

Culturally appropriate environment for patient safety and deployment of an incident reporting system, encouraging the staff to ask question in case of obscurity and resolving the issue of lack of man power, detachment and pursuing the test results in form of root analysis of the events and reporting the critical results

0 11 1 5 3 20

Medical equipment management and process standardization

Regular calibration of medical equipment, emergency service of medical equipment and devices, checklists for maintenance of the tools and facility management, purchasing of protective equipment, creating a qualitative committee and monthly views of the equipment of Radiology unit. Purchasing safety equipment for safe transfer

0 10 3 6 1 20

Improvement of patient identification process

Applying key identifiers in patient identification, improvement of the patient’s recognition processes and revising the guidelines for the correct recognition of the patients

0 8 0 6 0 1

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