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 Table of Contents  
Year : 2013  |  Volume : 1  |  Issue : 2  |  Page : 92-98

Using failure modes and effects analysis techniques in assessment of medical records errors in Qadir hospital, Shiraz in 2012-2013

1 Medical Management and Informatics College, Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran
2 Department of Health Management, Medical Management and Informatics College, Shiraz University of Medical Sciences, Shiraz, Iran
3 Student Research Committee Medical Management and Informatics College, Shiraz University of Medical Sciences, Shiraz, Iran

Date of Web Publication4-Mar-2014

Correspondence Address:
Hamed Rahimi
Master's Degree Student in Health Services Management, Faculty of Health Management and Informatics, Students Research Committee of Shiraz University of Medical Sciences, Shiraz
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Source of Support: This research is an approved project by the Students Research Committee and the Research Deputy of Shiraz University of Medical Sciences, No. 91-6144, and sponsored by the Shiraz University of Medical Sciences, Conflict of Interest: None

DOI: 10.4103/2347-9019.128122

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Introduction: Failure modes and effects analysis (FMEA) is a preventive method to improve and increase system safety. Using this technique, four selected process errors were identified, evaluated, prioritized and analyzed, in medical records section in Qadir hospital in Shiraz. Materials and Methods: This is an applied descriptive study in which using FEMA in medical records section were identified and analyzed. The included steps are: Processes selection, drawing processes flowcharts, determination of failure modes and effects by brainstorming, prioritization of failure modes, determination of root causes of failure modes using Eindhoven classification model. Results: Using FEMA methodology, we found that 41 failure modes in 4 selected processes. Totally, 13 failure modes with risk priority number ≥100 were identified as "non-acceptable risk" and their root causes were classified according to Eindhoven Classification model. Conclusion: By emphasizing on preventive approach and team work, FMEA technique can enhance staff precision and attract their attention to their possible professional weaknesses in recording medical errors and prevent their failure.

Keywords: Failure modes and effects analysis, hospital, medical records section, risk management

How to cite this article:
Rahimi H, Kharazmi E, Shafeghat T. Using failure modes and effects analysis techniques in assessment of medical records errors in Qadir hospital, Shiraz in 2012-2013. Int J Health Syst Disaster Manage 2013;1:92-8

How to cite this URL:
Rahimi H, Kharazmi E, Shafeghat T. Using failure modes and effects analysis techniques in assessment of medical records errors in Qadir hospital, Shiraz in 2012-2013. Int J Health Syst Disaster Manage [serial online] 2013 [cited 2022 Sep 25];1:92-8. Available from: https://www.ijhsdm.org/text.asp?2013/1/2/92/128122

  Introduction Top

Today, to be protected against various surrounding risks, and also to maintain their identity in the competitive era, all businesses are tending towards risk management. Medical records section is a section providing various services to patients, physicians and care team members, in which issues such as the intensity, competition, increase in expectations, and changes in customers' demands and expectations would increase obligations of service providers to eliminate errors and defects in their activities. Otherwise, they would lose their share in the market due to reduced customer satisfaction. [1]

Risk is the uncertainty about an incident in the future. Greater the uncertainty, higher the risk would be. Risk management in health care, refers to a diverse group of measures to improve the quality and ensure the safety of services for the patients. In health care system, particularly in hospitals, problems resulting from employees' negligence or poor performance have always made difficulties for the managers. [2]

To improve the performance of the units under his supervision and to provide effective services and better performance, manager of medical records section must have expertise and adequate knowledge of management principles. Recognition of obvious and hidden problems of medical records section and providing appropriate solutions are the most important tasks the manager of the section has. [1]

The loss of document data and wrong filing which would make following files recoveries impossible, are among the most important risks threatening the medical records section. [1]

There are several methods to assess the potential risks. One of the most reliable methods is Failure Mode and Effects Analysis (FMEA) that is used for risk management and reduction of effects. [3]

The history of FMEA goes back to more than 30 years ago. It was first introduced in 1960s in the aerospace industry. The use of the technique was then expanded to different companies and industries. [4]

The primary use of FMEA in the field of health care goes back to early1990s, when it was used for preventing medication errors in hospitals. [5]

FMEA is a systematic tool and preventive approach based on teamwork which is used for definition, identification, assessment, prevention, elimination or controlling conditions, causes and effects of potential failures in a system, process, project or service. For FMEA to be performed, prediction of errors and finding ways to avoid them are required. [3]

FMEA process not just increases safety, but also can be used for increasing efficiency and effectiveness and reducing costs, as well as improving the quality. [6]

In Tad Richard study of Health care Failure Mode and Effects Analysis (HFMEA), was used for assessment of the chemotherapy process. A multidisciplinary team was formed and some preventive activities were proposed to eliminate the possible risks. Totally, 11 different high score risks were determined in inpatient and outpatient procedures. Computerized prescribing was adopted to eliminate potential risks in chemotherapy. Prescribing errors dramatically decreased from 3.34-0.4%. Chemotherapy is considered a risky process and there are possible risks in the entire preparation process and giving the medicine. HFMEA is a useful tool for assessing the potential risks in the health care process. [7]

In their study in 1386 to identify the potential risks of medical records section, Yarmohammadian et al., identified 56 potential risks of which 24 risks were related to reception unit. The highest risk priority number was related to the "inability of the employees of reception unit to readout the hospitalization order". This study showed that techniques such as FMEA, performed with a preventive approach and based on effective teamwork, increase employees' accuracy and brings their attention to their potential professional weaknesses. [1]

  Materials and Methods Top

This is an applied descriptive study analyzing the effects of errors using FMEA methodology. The study was performed during February to November, 2012 on four selected process of medical records section in Qadir specialized Hospital for Mother and Child. Required data were obtained using group interviews and brainstorming, in addition to FMEA meetings. The results of each step were recorded in the FMEA worksheet. Also, Eindhoven Classification Model (ECM) was used to identify root causes of errors. FMEA is a system improvement technique through increasing system safety. The "error" is defined as "the inability of a system unit to carry out a specified activity". [8]

The study was carried out in six stages as follows:

Selection of high risk processes and team forming

At this stage, based on the needs of hospitals and hospital administrators' views, four processes were selected as high risk. Then, FMEA team related to the process (including hospital administrator, director of nursing, the medical records director, and three medical records experts) was formed.

Drawing process chart

After the selection stage, process charts were designed and approved using team interviews. Individual interviews were also used to improve the process charts. The activities of each of the four processes were finally recorded in the column of "activity" in the FMEA worksheet according to the charts.

Brainstorming of potential scenarios and determination of error types

At this stage, potential errors or possible errors of any of the activities listed in the four selected processes of the medical records section were studied and their types were determined. Each error was recorded in the "potential errors scenarios" column of the final worksheet with the consensus of team members.

Prioritizing errors

At this stage, all identified error conditions were prioritized by their risk priority number (RPN). For each error condition, RPN was calculated by multiplying three indicators of the severity of the error, the probability of occurrence, and detect ability. Considering the range 1 < RPN < 1000 (due to rating scale of one to 10 for any of the three indicators), errors with RPN > 100 were identified as high risk errors.

Identifying root causes of errors

At this stage, the root causes of error conditions with RPN > 100 were identified using ECM. This model distinguishes two types of errors: Latent errors (including technical and organizational errors), and active failures (human errors and others). The error topics are: a) technical errors in: 1- the physical structure of section, 2- equipments, software, hardware, etc., 3- materials, 4- out of the scope of the section; b) organizational errors in: 1- information systems, 2 - protocols and procedures, 3- management decisions and priorities, 4 - organizational culture, 5 - out of the scope of the section; c) human errors in: 1- knowledge, 2- qualification, 3 - cooperation or teamwork, 4 - initial assessment, diagnosis, or harvesting, 5 - performance, 6 - monitoring, 7- skill, 8 - out of the scope of the section; d) other factors in: 1 - patients and their accompanies, 2 - not classified. ECM is specifically designed for health care.

Proposing strategies

At this phase, strategies for error conditions with RPN > 100 in the selected processes were proposed according to the scores obtained from three indicators of S, O and D, and their root causes.

  Results Top

Firstly, based on team brainstorming, four processes of reception, statistics, archive and encoding were selected as high risk processes in the medical records section, and their errors were identified and analyzed using FMEA technique.

Generally, 23 listed activities were drawn for steps of four processes flow charts. Then, 41 potential error conditions were detected and recorded in the final FMEA worksheet. Also, detected errors were classified into four types of "performance errors", "decision making errors", "recording errors", and "informing errors" [Table 1].
Table 1: FMEA Worksheet

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In the fourth step, after calculating the RPN for each of the errors, 13 errors with RPN > 100 were totally detected as high risk unacceptable errors in the four processes. In the fifth step, the root causes of errors with unacceptable risks were detected by brainstorming of team members based on ECM model, and were recorded in the "route causes" column of the FMEA worksheet. Finally, suggestions were provided in three formats of severity reduction of the error, reducing the incidence of errors, and increasing error detection capabilities, so that necessary measures would be developed with a focus on these three strategies. Team members also expressed their suggestions which were recorded in the "proposed measures" column of FMEA [Table 1].

  Discussion Top

As results indicate, of the total 41 potential errors detected, the largest number of errors is related to the reception and archive processes with 15 and 14 errors, respectively. The highest risk priority number is related to "incompleteness of main and subsidiary items of patient's file" (RPN = 351). Among all detected errors in the four processes, a major part of potential errors are performance errors (29 errors). Also, of the total 13 unacceptable high risk errors, nine errors were performance errors. Based on ECM model, it can be found that the root causes of most high risk errors are of human type (10 errors, 76.92%) and others are of organizational type (3 errors, 23.08%). However, by holding training courses for related groups including medical staff and secretaries of medical units, such errors are controllable.

In 2007, Yarmohammadian et al., showed that of the total 56 potential errors, 24 errors were related to reception unit, and the highest RPN was related to "staff inability to read the hospitalization order". [1]

In their study in 2006, Day et al., showed that the suggestions made by the FMEA team were classified in terms of training measures. [9]

All organizations have risks. The risks are caused by internal or external factors, but the way to manage risks is the key factor in an organization's success or failure. [10] Handel et al., argue that having risk management and quality programs in hospitals can be effective in reducing medical errors. [11] In their study, Alen et al., concluded that by applying risk management, the error rate due to accidents in the hospital's emergency unit may be reduced from 3.24% to 0.48%. [12]

For patient's safety to be provided, Spath believes in system redesigning as a necessary factor to detect and correct unavoidable human and process errors in a timely manner, and, therefore, explains that the FMEA method as a technique to promote systematic thinking for achieving patient's safety and considers it as a prospective risk assessment method which among other techniques, has more affinity to health-care sector. [13]

Also, by arguing the wrong traditional thinking that says human errors consist the majority of errors, Woodhouse et al., introduce FMEA as a new approach aimed at preventing errors and improving patient safety. [14]

FMEA mechanism should be carried out continuously. The reason is that by reducing the risk of an error, the risk number of another error may change. Thus, reviewing RPNs after performing modifying actions is necessary both to monitor the effectiveness of measures and to determine changes in other error indicators associated with the modified error. [8] In their study of FMEA method, Robinson et al., showed that, although, establishing a computerized system to record medical orders would result to reduced prescription, administration, and distribution errors in chemotherapy, but new errors may be expected to occur. Thus, they suggest a continuous FMEA method to deal with these errors. [15]

Therefore, by establishing any new system or process, some errors may decrease, while others increase, or new errors arise.

Farnaz Nobari et al., argue that no system is currently being implemented in hospitals in Iran to report errors, whereas establishing such system is of great importance. Also, in order to detect and reduce all risks in hospitals, they suggest a team-based prospective FMEA method to be trained to all assistants at all levels of training hospitals, so that the systemic view of this method to the nature of errors, reduce the people's fear of reporting errors. [8]

However, in recent years, clinical governance system has been established in hospitals, and risk management is one of its seven dimensions. Thus, measures have been adopted in regards of reporting errors, but yet, further studies are required. Clinical governance system is a good approach for hospitals. The main goal is to ensure the highest quality of clinical services. Clinical governance and associated risk management have a systematic view to reporting errors, and FMEA is the mechanism it uses in this regard.

One of the main features of FMEA is proactive measures rather than reactive measures in dealing with the failures, or in other words, preventive action before the accident and not after. FMEA is a systematic method which first, detects hidden and apparent errors and failures in the system, and second, takes appropriate measures to eliminate them. Thereby, FMEA can be used as a tool for continuous improvement of quality of products and services in the organizations.

  Conclusions Top

In general, techniques such as FMEA which have a team based preventive approach, increase employees' accuracy and bring their attention to their potential career weaknesses. The advantage is that the employees are not seen as wrong doings in the systematic view of such mechanisms. Instead, by finding root causes particularly for human errors, a safe environment without any risks and tensions is tried to be provided for the employees. Also, tracking high risk errors in this study by one of the "root cause analysis" (RCA) methods called ECM has helped in reducing them pact of some limitations of FMEA such as time-consuming process and thus increased the efficiency and effectiveness of the method.

  References Top

1.Yarmohammadian M, Tofighi S, Esfahani SS, Naseribooriabadi T. Risks involved in medical records processes of Al-Zahra hospital. Health Inf Manage 2007;4:51-9.  Back to cited text no. 1
2.Zaboli R, Karamali M, Salem M, Rafati H. Risk management assessment in selected wards of hospitals of Tehran. J Mil Med 2011;12:197-202.  Back to cited text no. 2
3.Ghanjal A, Sedaghat A, Motaqhey M, Dellavari AR, Tavakoli R. Risk management and assessment of field emergency center using FMEA method. J Mil Med 2008;10:167-74.  Back to cited text no. 3
4.Mcdermtt RE, Beauregard MR. The basis of FMEA. Quality Resources. New York 1996.  Back to cited text no. 4
5.Duwe B, Fuchs BD, Hansen-Flaschen J. Failure mode and affects analysis application to critical care medicine. Crit Care Clin 2005;21:21-30, vii.  Back to cited text no. 5
6.Cohen MR, Senders J, Davis NM. Failure mode and effects analysis: A novel approach to avoiding dangerous medication errors and accidents. Hosp Pharm 1994;29: 319-30.  Back to cited text no. 6
7.Waston MC, Bond CM, Johnston M, Mearns K. Using human error theory to explore the supply of non-prescription medicines from community pharmacies. Qual Saf Health Care 2009;15:244-50.  Back to cited text no. 7
8.Nobari AJ, Tofighi SH, Hafezimoghadam P, Maleki MR, Goharinezhad S. Risk assessment of processes of Rasoule Akram emergency Department by the failure mode and effects analysis (FMEA) methodology. Hakim Res J 2010;13:165-76.  Back to cited text no. 8
9.Day S, Dalto J, Fox J, Turpin M. Failure mode and effects analysis as a performance improvement tool in trauma. J Trauma Nurs. 2006;13:111-7.  Back to cited text no. 9
10.John L. The evolution from risk management to patient safety-case studies from the Harvard medical system. Japan World Econ 2003;15:459-68.  Back to cited text no. 10
11.Handel DA, McConnell KJ. Emergency development length of stay and predictive demographic characteristics. Ann Emerg Med 2007;50:10-4.  Back to cited text no. 11
12.Verbano C, Turra FA. Human factors and reliability approach to clinical risk management: Evidence from Italian cases. Saf Sci 2010;48:625-39.  Back to cited text no. 12
13.Spath PL. Using failure mode and effects analysis to improve patient safety. AORN J 2003;78:16-37.  Back to cited text no. 13
14.Woodhouse S, Burney B, Coste K. To Err is human: Improving patient saftey through failure mode and effect analysis. Clin Leadersh Manag Rev 2004;18:32-6.  Back to cited text no. 14
15.Robinson DL, Heigham M, Clark J. Using Failure Mode and Effects Analysis for safe administration of chemotherapy to hospitalized children with Cancer. Jt Comm J Qual Patient Saf 2006;32:161-6.  Back to cited text no. 15


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