APPLICATION OF A PROCESS-ORIENTED ANALYSIS METHOD
TO CLINICAL LABORATORY TESTING
FOR ANALYZING MEDICAL INCIDENTS
SANO Masataka, Masahiko MUNECHIKA, Masaaki KANEKO
mo3@fuji.waseda.jp, munechika@waseda.jp,mkaneko@ruri.waseda.jp
Graduate School of Creative Science & Engineering, Waseda University, Japan JSQC
3-4-1 51-14-12 Okubo Shinjuku Tokyo, JAPAN 169-8555
ABSTRACT
Decreasing medical malpractices that threaten patients’ safety is one of the most important issues in hospital administration.
Process-Oriented Analysis Method for Medical Incidents (POAM) has been proposed for analysis of the incidents of medication-related
errors, as an attempt to change the medication process with an aim to decrease errors. Since POAM was originally developed for the
medication process, this study aims to establish a method for analyzing clinical laboratory testing by modifying POAM. POAM comprises
a medication model and a viewpoint list. Therefore, for clinical laboratory testing, both these component should reflect the characteristics
of the working process. In order to identify the required adjustments, 36 actual incidents in clinical laboratory testing were analyzed. As a
result, it was confirmed that the contents of an incident report of clinical laboratory testing are adequate for POAM to reveal the incident
status. Moreover, 36 cases were examined for determining the incident status by using the medication model and for recognizing the error
factors by reviewing the viewpoint list. With these steps, the process of analysis with the model and viewpoint list is proposed. This study
proposed POAM for the analysis of clinical laboratory testing by showing the analysis of 36 actual incidents occurring in a hospital. In
addition, other cases could be analyzed with POAM. Since the number of actual incidents is limited, the proposed steps need to be applied
to more cases. However, in order to identify a suitable working method, the proposed method has been confirmed to be partly useful for
incidents of clinical laboratory testing.
Keywords: Patient safety, incident analysis, process approach
PURPOSE
Reducing the medical malpractice that threatens patients’ safety is one of the most important issues in hospitals. Moreover, many medical
malpractices are caused habitually; several members of staff continue to make similar mistakes.
It is necessary to detect the core factors underlying mistakes by analyzing cases using incident reports in order to prevent similar mistakes
recurring. Human factor is one of the main factors contributing to such mistakes. These factors are neither easy to eliminate or change;
consequently, in such cases, it may be more effective to change working methods.
The Process-Oriented Analysis Method (POAM) for medical incidents is proposed as an analysis method for incidents of medication
errors that is designed to change medication processes, thereby reducing these errors. Nurses in a ward in Hospital A used POAM to analyze
the incidents in which they were involved and to detect the problems associated with their work process in order to reduce such incidents.
Although POAM was originally developed for medication errors, it has been suggested that this method is compatible with other types
of incident, as long as errors arise whilst following an established process. To date, however, POAM has not been applied to the incidents
associated with clinical laboratory testing. Nevertheless, POAM is considered to be potentially useful for such incidents since laboratory
tests are conducted in accordance with standard practice. By examining actual incidents associated with clinical laboratory testing, this
study aims to establish an analytical method for clinical laboratory testing using a modified POAM.
POAM
POAM (Process-Oriented Analysis Method) for medical incidents was proposed for the analysis of medication incidents such that medical
staff would be able to realize a process-oriented approach to patient safety (Murase, 2003; Iwasawa, 2006). POAM comprises a medication
model and viewpoint list. Figure 1 shows a model of the medication process. It describes how a nurse receives “Information” such as a
doctor’s instructions or the results of an examination, then prepares “objects” such as medicines or medical devices for medication, and
finally executes a “job” such as an injection. Medical incidents occur due to an error during any one of the three aforementioned steps.
POAM utilizes the medication model in order to gain an understanding of the circumstances surrounding medication incidents.
objects
・medicines
・materials
information
・doctor’s instructions
・messages from other nurses
・examination outcomes
jobs
correct objects
correct information
・injects
・oral medication
・set materials
Nurse
correct jobs
Figure 1. Medication Model
A viewpoint list summarizes the viewpoints required to detect process factors; that is, the causes of medication incidents that can be
eliminated by changing working methods. The viewpoint list enables an analyst to easily identify the process factors associated with
medication incidents. Moreover, the procedure of analysis using these tools is proposed in the form of a summary sheet of analysis.
In this way, POAM provides a means by which to understand the root error which is an error in the most beginning process. Here showed
the step of analysis for medication error.
The scope of POAM covers not only medication incidents but also incidents related to jobs executed by following fixed processes such
as laboratory tests and the tasks of medical clerks. Murase (2003) and Iwasawa (2006), however, did not indicate how the procedure of
POAM could be applied to incidents associated with clinical laboratory testing. Moreover, Hospital A does not use POAM for these
incidents.
APPROACH
This paper aims to establish an analytical method for incidents associated with clinical laboratory testing using a modification of the POAM
for medication incidents. Therefore, the medication model and viewpoint list for clinical laboratory testing reflect the characteristics of the
working process. In order to clarify these adjustments, analysis of actual incidents in clinical laboratory testing was conducted. Initially, the
contents of an incident report were examined in order to ensure that it included sufficient information to enable the application of POAM.
Figure 2 shows the format of the incident reports used in Hospital A.
Incident Sheet
Date of subm it
B asic Inform ation
Date
/
Patient ID
R eporter
/
Tim e(HH:M M )
A ge
W ork experience
yr.
yr.
/
m o. Disease
m o. Shift(day/night)
Sum m ary
Plan
to w hom
nam e of m edicine
am ount
w hen
how
to w hom
nam e of m edicine
am ount
w hen
how
Did
W ork process
①
Describe w hat you actually did during the case
②
③
④
⑤
⑥
Figure 2. Format of the incident report used in Hospital A
An incident report for medication collates information on the date, contents, and process of a case. POAM is subsequently conducted
using this information. Since figure 2 shows that all the information required to conduct POAM is present, it is confirmed that the contents
of the incident report for clinical laboratory testing contains sufficient information for POAM to reveal the circumstances surrounding a
given incident.
× to December, 2007.
There were 36 incident reports associated with clinical laboratory testing in Hospital A during the period from January
In order to identify the adjustments required for a POAM for clinical laboratory testing, these 36 actual incidents were analyzed.
Initially, the 36 cases were examined in order to describe the circumstances of each incident using the medication model. The reason for
unconformity was recorded in order to establish the model for clinical laboratory testing under circumstances in which it is not possible to
describe the case using the medication model.．
Next, the 36 cases were analyzed in order to identify error factors using the viewpoint list. The viewpoint list was used to extract error
factors. Therefore, it should include the characteristics of the working method of clinical laboratory testing. Hence, each case was analyzed
using the viewpoint list, and if it was not possible to extract the error factor using the extant viewpoint list, it was considered necessary to
add a new question. In addition, the expressions used in the viewpoint list were examined to ensure that they were applicable to clinical
laboratory testing since the list was originally developed for medication processes.
RESULTS OF THE ANALYSIS
Description of the status of an incident using the medication model
Among the 36 cases examined, there were some incidents, such as complications with the use of a catheter that were unrelated to the
working process. As a result, 3 cases were excluded, leaving 33 cases to be analyzed. For each case, the circumstances are described using
the medication model. In order to analyze the cases in clinical laboratory testing, the definitions of “Information,” “Object,” and “Jobs”
were changed. The details are shown in Table 1.
Table 1 Comparison of the definitions of “Information,” “Objects,” and “Jobs”
Item
Definition for medication process
Definition for clinical laboratory test
“Information”
Process from receiving information to recognizing for
Input to accomplish the task; not only instructions but also
preparation, such as doctors’ instructions, message from a
includes visiting patients and testing samples
nurse, and examination results
“Objects”
“Jobs”
Preparation of materials for medication, such as sorting
Preparation of jobs, such as setting up devices and/or
medicines and selecting medical devices
preparing patients
Performing tasks on patients using the prepared objects,
Execution of tasks, such as testing and inputting results
such as injections and operating medical devices
“Information” describes the input necessary for the worker to execute the job. It includes not only instructions given by doctors but
testing samples and visiting patients since these items are sometimes triggers of the task. “Objects” are prepared by the worker for “Jobs.”
This means adjustment of the settings of test machines or preparation of patients such as indicating posture for receiving radiographic
examination. “Jobs” are final executions such as testing and reading the results.
The results of the analysis based on these definitions are shown in Table 2.
Table 2. The results of analysis using the model
Description
Number of case
Lack of “Information” and source of information
2
NO “Objects”
5
Other
26
TOTAL
33
The result shows that some cases lack “Information” or “Objects.” Consequently, it is possible to describe 26 out of the 33 cases using
the model. For 2 cases, there was neither appropriate “Information” nor a source of information, and in 5 cases there were no “Objects.”
This means that it is necessary for certain steps in POAM-medication analysis to be changed since each field needs to be filled in; POAM
for clinical laboratory testing sometimes lacks these items.
In addition, error factors were extracted using a viewpoint list. In the error in examination items, cognition error of examination item
and similar outlook in test cotton sample in “Information” are extracted as error factors. Therefore, expressions of question are examined to
fit the situation in clinical laboratory testing.
Proposal for an analytical procedure for incidents associated with clinical laboratory testing
Step 1. Understanding the circumstances of the incidents
1-1 Understanding errors by describing the model
Describe the model information by entering information, objects, and jobs. These items are not necessarily always entered.
1-2 Understanding the stage of errors
Understand whether the error occurred in the information stage, the objects stage, or the jobs stage.
1-2 Understanding errors of other participants
Understand errors committed by other participants in the incidents, such as doctors, pharmacists, and nurses, who have not failed but
are connected with the incidents.
Step 2. Analyzing factors
2-1 Investigate the existing standard process
Research the standard and describe the procedure of a task.
2-2 Identifying problems associated with the process
Consider the problems of the procedure of a medical service and identify the error factors using the viewpoint list shown in Table 3.
Step 3. Planning countermeasures
Devise countermeasures designed to change the process, thereby reducing the risk of incidents.
Table 3. A viewpoint list for clinical laboratory testing
Information
Was there a source of information? If not, why was there no trigger and how did the worker realize the task?
Was there something that had a similar outlook/name to convey information?
Were there multiple sources of information?
How were instructions conveyed, on paper or orally?
On Paper
Oral instruction
Where was the source of information?
Did you record the information?
Was the information ambiguous?
Were the contents or expression of the information easy to
What did the information tell you?
understand?
When did you try to confirm the information?
Objects
Who prepared the objects?
Did you prepare multiple things at the same time? Why
How were the objects prepared?
were there wrong objects?
Did you prepare the object in the wrong place?
Did you confirm after you prepared, such as settings?
Was
Was there something difficult when you prepared?
there
something
that
had
a
similar
outlook/name?
Jobs
Did you have multiple jobs to perform?
Did you confirm/record after you had executed the job? 
Was there something that interrupted your task?
How did you manage after the job?
Were there other patients whose name or age was similar?
Was there something difficult when you executed the task?
1-1　Description of the status (Fill No.1. to No.7.)
Objects
3.Correct
6.Incorrect
Information
Correct source
2
Correct contents
7
Jobs
4. Correct
Incorrect source
Incorrect contents
5. Incorrect
1
1-2　Error
Information
Objects
1-2　Details of Error
Jobs
1-3　Errors of other person
2-1　Work standard
2-2　Factors of incidents
3　Countermeasures
Figure 4. Analysis sheet
Table 3 shows a viewpoint list and Figure 4 shows the analysis sheet for POAM for clinical laboratory testing. With these tools,
analyst plan countermeasures to reduce incidents.
DISCUSSION
The applicability and effectiveness of POAM in clinical laboratory testing
Clinical laboratory testing includes many tasks such as examination of blood samples, radiation inspection, and calibration. Since these are
common tasks that can be broken down into processes, process-oriented analysis is applicable. POAM was originally devised for the
analysis of medication-related errors using a process-oriented approach, with the objective of reducing such incidents.
The various methods of analysis include Medical SAFER, the SHEL-Model, the 4M-4E Model, and event-relation diagrams. These
methods facilitate the identification of many factors since they possess multiple viewpoints. However, medics who do not have knowledge
of such analytical methods tend to identify only the human-related factors, such as lack of attention, and it takes a long time to analyze an
incident on the basis of these factors. Due to these difficulties, hospitals limit the number of analyses, and countermeasures tend to be
limited to campaigns urging staff to pay more attention during their work. Consequently, similar mistakes recur since nothing has changed.
In contrast, POAM is a method that focuses on the problems of the working process. The model readily describes the status, which
shows only the information related to the process. The viewpoint list offer opportunities to identify errors committed by other persons, the
existence of a work standard, and problems associated with the work method. This helps to reduce the time of analysis so that ward nurses
can effectively identify the problems associated with their work method. In addition, there tends to be less of a limit on the number of
accidents that can be analyzed since POAM takes less time.
Modification of the model and viewpoint list
The model that describes the status of incidents in clinical laboratory testing is a modified version of the medication model. Doctors’
prescriptions are invariably triggers of the medication process. Therefore, the medication process always includes “Information” in its
model. In addition, medicine is always prepared before it is delivered to patients. Therefore, describing “Objects” makes it possible to
identify an error in preparation. Some tests entail no preparation or no information since the task is executed only periodically. In these
cases, “Information” and “Objects” are not always entered. Indeed, the fact that there is nothing to be filled itself indicates a potential
source of error. Therefore, questions designed to extract these factors are added.
Team building for POAM
It is recommended that POAM analysis teams are formed in order to investigate medication-related incidents (Iwasawa, 2006). The reason
for this being that it is difficult for any one person to become a proficient user of POAM and to gain familiarity with process-oriented
thinking merely through involvement with his or her own case. Typically, each medic will be involved in only one or a few such incidents.
Clinical laboratory testing is executed mainly by inspecting engineers, although there are other members of staff who conduct tests required
by doctors, and specimens are sometimes collected by ward nurses. Therefore, these members should be included in a team since their
viewpoints are necessary. In addition, they also play an important role in planning countermeasures designed to change existing work
processes.
There is a debate as to whether the person who actually caused the incident should be included in the analysis meeting since this
presents an opportunity to level accusations. [However, it is suggested that this person should attend the meeting since he/she is familiar
with the circumstances of the incident, and it provides a good opportunity to learn process-oriented thinking that does not apportion blame.
In order to accomplish these objectives, participants must understand that the meeting is an opportunity to undertake a review of the process.
This type of consensus will assist in the execution of good analysis.
CONCLUSION AND FUTURE ISSUES
This study proposed POAM for clinical laboratory testing, which was assessed by analyzing 36 actual hospital incidents. Components of
the medication model and viewpoint list were extracted and these were used to construct a model for clinical laboratory testing. This model
was then used to analyze actual incidents.
In the future, it will be important to increase the number of cases analyzed in order to fine-tune the method. Moreover, it will be
necessary identify the characteristics of cases that are described in the absence of “Information,” “objects,” and “jobs.” Finally, it will be
imperative to develop a method for implementing countermeasures through discussions with analysts in the ward based on an analysis of
actual cases.
ACKNOWLEDGEMENTS
The authors would like to express their appreciation to the safety managers of Hospital A for disclosing the case information and for
valuable discussions.
REFERENCES
Murase T, (2003), A Study on the Process Oriented Analysis Method for Medical Incidents, Master thesis of Waseda University
Ozaki I, Munechika M., (2005), A Study on the Reduction of Accidents in Medication by Error Proofs, Byoin Kanri Vol.42, No.3 121-133
Iwasawa K. (2006), A Study on the Process Oriented Analysis Method for Medical Incidents, 4th ANQ
Shinomiya T. (2007), Viewpoints of Analysis for Medical Incidents, Graduation thesis of Waseda University