ADOPTING THE HEALTHCARE FAILURE MODE AND EFFECT ANALYSIS
TO IMPROVE THE BLOOD TRANSFUSION PROCESSES
Chao-Ton Su1,*, Chia-Jen Chou1, Sheng-Hui Hung2, Pa-Chun Wang2,3,4
1
Department of Industrial Engineering and Engineering Management, National Tsing Hua University, Hsinchu 30013,
Taiwan, R.O.C.
*Corresponding author. Email: ctsu@mx.nthu.edu.tw
4
2
Quality Management Center, Cathay General Hospital, Taipei 10630, Taiwan, R.O.C.
3
Fu Jen Catholic University School of Medicine, Taipei County 24205, Taiwan, R.O.C.
Department of Public Health, China Medical University, Taichung 40402, Taiwan, R.O.C.
The aim of this study is to conduct the healthcare failure mode and effects analysis (HFMEA) to evaluate the risky and
vulnerable blood transfusion process. By implementing HFMEA, the research hospital plans to develop a safer blood
transfusion system that is capable of detecting potentially hazardous events in advance. In this case, eight possible failure
modes were identified in total. Regarding the severity and frequency, seven failure modes were identified to have hazard
scores higher which are than 8. Five actions were undertaken to eliminate the potential risk processes. After the completion
of HFMEA improvement, from the end of July, 2008 to December 2009, two adverse events occurred during the blood
transfusion processes and the error rate is 0.012%. The HFMEA proves to be feasible and effective to predict and prevent
potentially risky transfusion processes. We have successfully introduced information technology to improve the whole
blood transfusion process.
Key Words: healthcare failure mode and effect analysis (HFMEA), blood transfusion, hazard score.
1.
INTRODUCTION
Reducing medical errors for a given healthcare process is critical to patient safety. Traditionally, risk assessment methods
in healthcare have analyzed adverse events individually. However, risk-evaluated approaches should reflect healthcare
operations, which are usually composed of sequential procedures. In other words, a systematic and process-driven
programming of risk prevention is necessary for every healthcare provider. Many studies have illustrated the necessities to
introduce risk analysis method in preventing the medical error ((Bonnabry et al., 2006); (Bonan et al., 2009)).
Healthcare Failure Mode and Effect Analysis (HFMEA) is a novel technology used to evaluate healthcare processes
proactively. HFMEA was first introduced by the Department of Veterans Affairs (VA) System and developed by the
National Center for Patient Safety (NCPS) in the United States. HFMEA is a hybrid risk evaluation system that combines
the ideas behind Failure Mode and Effect Analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP), and the
VA’s root cause analysis (RCA) program. An interdisciplinary team, process and subprocess flow drawing, identification of
1
failure mode and its cause, a hazard scoring matrix, and a decision tree to determine system weakness are usually included
in HFMEA. Currently, the HFMEA method is encouraged by the American Society for Healthcare Risk Management for
hospitals in the United States (Gilcheist et al., 2008).
Clinical researches have identified blood transfusion as a significant risky process (Klein, 2001; Rawn, 2008). Errors in
blood transfusion result in immediate and long-term negative outcomes including the increase chance of death rates, stroke,
renal failure, myocardial infraction, and infection, among others. Therefore, reducing the risks of blood transfusion is a
major patient safety issue for all hospitals. The blood transfusion process is setting on top of the list for process analysis,
since the process affects a large number of patients and the procedure is complex in nature (Burgmeier, 2002). Linden et al.
(2002) indicated that the blood transfusion is a complicated system involving the hospital blood bank, patient floor,
emergency department, operating room, transfusionist, and transporter. A more comprehensive and risk proactive analysis
of the blood transfusion process is necessary to improve patient safety.
A series of transfusion-related adverse events take place in the research hospital have urged the Patient Safety Committee
to take decisive actions to prevent harmful medical errors resulted from transfusion-related processes. An efficient risk
prevention method was anticipated to reduce the number of adverse blood transfusion events at the research hospital. The
aim of this study is to conduct the HFMEA to evaluate the risky and vulnerable blood transfusion process. By implementing
HFMEA, the research hospital plans to develop a safer blood transfusion system that is capable of detecting potentially
hazardous events in advance.
2.
REAL-LIFE EXAMPLE
2.1. Setting
The research was conducted in the Cathay General Hospital, a 600-bed, university-affiliated, tertiary referral acute care
medical center located in downtown Taipei, Taiwan. The study was approved by the IRB of the Cathay General Hospital.
2.2. Composition of the HFMEA team
Led by the Vice Director of the Clinical Laboratory Department, a multi-disciplinary team was organized following the
guidelines of HFMEA as described in the U.S. Department of Veterans Affairs’ HFMEA toolkit (Derosier et al., 2002). The
team consists of 10 members from 6 departments, including the quality management center, information technology
department, nursing department, clinical laboratory department, blood transfusion committee, and dispatch center, worked
under the supervision of 2 external process engineers from the National Tsing Hua University.
2.3. Time Period
This study was divided into three stages, namely, planning, execution, and follow-up. A one and a half hour meeting was
held per month. A total of 12 meetings require more than 180 man-hours.
1.
Planning phase (from July, 2007 to August, 2007)
The main goals of this stage were to learn the HFMEA procedure and to collect baseline data on blood transfusion errors. In
2
addition, the multidisciplinary team was also organized during this phase.
2.
Execution phase (from September, 2007 to June, 2008)
This phase focused on drawing a detailed blood transfusion process, constructing the failure modes and identifying their
causes, determining hazard scores, deciding on recommendation actions, and recognizing responsible departments.
3.
Follow-up phase (from July, 2008 to December, 2009)
The blood transfusion error rate is the most critical index proving the effectiveness of the HFMEA project. The blood
transfusion committee worked continuously to monitor the error rate and to make sure that its trend was stable.
2.4. HFMEA Procedure
The HFMEA procedure used to examine potential failures in the blood transfusion was adopted from the HFMEA
guidelines (Derosier et al., 2002). More application of detailed HFMEA procedure could be found in ((Esmail et al., 2005);
(Linkin et al., 2005); (Van Tilburg et al., 2006); (Habraken et al., 2009)). Followings are the key steps description of the
HFMEA process:
Step 1. Define the HFMEA topic.
Step 2. Assemble the team.
Step 3. Graphically describe the process
Step 4. Conduct a hazard analysis.
Step 5. Actions and outcome measures
2.5. Process description
The process of blood transfusion was divided into six main phases: doctor’s order (prescription), blood preparation,
cross-matching, blood ordering, blood delivery, and blood transfusion. Figure 1 illustrates the detailed steps of blood
transfusion.
1
2
3
4
5
6
Doctor’s
Order
Blood
Preparation
Blood
Cross-matching
Blood
Ordering
Blood
Delivery
Blood
Transfusion
Subprocesses:
Subprocesses:
Subprocesses:
Subprocesses:
Subprocesses:
Subprocesses:
A. Checking patient
A. Checking of patient
A. Signature and
A. Placing order by
A. Blood delivery
A. Checking of blood
information of patient
B. Generating the
doctor’s order
C. The nurse brings the
essential items to is
the patient’s location
ID at bedside
B. Extracting the blood
C. Preparing for crossmatching
D. Transportation by air
phone
reconfirmation
cross-matching
B. Confirmation before
release of blood
C. Issuance of cross-
C. The dispatch center
B. Execution of the
(courier) checks the
matching report
B. Blood taking
C. Transport
product
B. Warming up of the
blood (if necessary)
C. Checking the
patient’s identity at
the bedside
shooter (urgent
blood product, the
dispatch) or courier
bed number, blood
D. Blood transfusion
type, and patient’s
E. Observing and
medical record
recording
F. Feed backing
number
Figure 1. Blood Transfusion Process
3
Step1: Doctor’s Order
The doctor first checks the patient information and gives professional order, which includes the blood transfusion request
form, blood testing form, blood product, and blood quantity. Then the nurse double checks the blood product, blood
quantity, and the patient’s ID per doctor’s order. The nurse then brings the essential items to the location of the patient.
Step 2: Blood Preparation
Before extracting the blood, two nurses double check the information of the identity of the patient. These pieces of
information include the name, ID, date of birth, medical record number, and blood type at the bedside. The information is
provided by the patient himself or can be seen on his bracelet. Next, the nurses write the bed number, date, name, blood
type, and the name of the transfusionist on the blank label. The nurses then confirm and append to the blood transfusion
request form. Before preparing to send for the cross-matching operation, the blood transfusion request form, blood testing
sheet, and specimen should be completed. Finally, the request form is sent to the blood bank by air shoot (urgent dispatch)
or transporter.
Step 3: Blood Cross-matching
The blood bank staff will sign for the specimen receipt and reconfirm the data, which includes the blood transfusion
request form, blood testing form, and basic information on the patient’s specimen. The inspection staff will then sign the
blood testing form and print out the receipt of signature label. The blood transfusion request form, specimen label, and
signature label are then rechecked before the cross-matching operation is performed. If the required data are correct, the
cross-matching operation will be implemented. Given the results, the nurses will verify whether those results match the
blood type of the patient. The nurse will then double check the blood transfusion request form, specimen label, the receipt
of signature label, and the cross-matching results.
For the cross-matching report to be issued, the verification of the signature label and the information about the patient
should be accomplished first. The nurses will then enter the inspection report into the laboratory information system (LIS);
the LIS will check if the inspection results indeed match the blood type of the patient. In addition, the nurses will enter
information on the required blood into the computer. The blood preparation operation is completed.
Step 4: Blood Ordering
The unit requiring blood gives a notice to the blood bank by telephone and issues a blood release form to the dispatch
center by air shooter. The blood bank staff will key in the patient’s medical record number that was provided by the nursing
staffs into the LIS. Next, the blood bank staff confirms the patient’s name and blood type with the nurses. The blood bank
staff then keys in the information, which includes the bed number, blood product, and blood quantity into the computer
according to the provided information. Finally, the blood bank staff will prepare the blood and cross check again, after that,
the nurses will scan the bar code on the blood pack into the computer, and the LIS will automatically verify the blood
product, blood type, blood quantity, and print out the blood release form. After the dispatch center receives the blood
release form, the staff will verify the blood product, the bed number, blood type, and the patient’s medical record number.
Next, the courier will prepare to transport the blood.
Step 5: Blood Product Delivery
The staff of the blood bank will write the data on the plastic bag: the data are based on the information from the blood
4
transfusion request form. The blood bank staff then puts the blood into the thermal insulation package. Next, the courier
brings the receipt of signature form and the blood release form, which had been charged to transport the blood. Before the
blood is taken, the blood bank staff will verify the blood release form, blood transfusion request form, receipt of signature
form, and the data on the plastic bag. Finally, the escort takes the blood product to the unit requiring blood.
Step 6: Blood Transfusion
Before transfusing the blood, the nurses not only check whether the blood appears strange (that is, if there is clotting,
bubbling, breakage, or discoloration), but also verify the doctor’s order, blood type, quantity, and blood transfusion request
form. Next, the nurses then warm up the blood under 37˚ C for 10-20 minutes, if necessary, to check the patient’s bed
number, blood type, and patient name on the blood bag. The nurses double check the patient’s identity which included
name, ID, birth date, and blood type at the bedside. The blood transfusion is then performed. The procedure begins with the
exhaustion of the cannula, followed by determining the size of the needle tip (the drip speed depends on the patient’s
situation). The last step is the change of the cannula based on the time or actual situation. During the transfusion, the nurses
will observe the condition of the patient and record patient’s response. After giving the feedback on the performed
procedure, the whole process is considered completed.
2.6. Evaluation
Because of the implementation of HFMEA, there has been only two adverse events occurred in the blood transfusion
process through 2009. Those action plans will be proliferated to the entire Cathay Healthcare System hospitals, including
the Cathay General Hospital, Sijhih Branch, Hsinchu Branch, and the Cathay Neihu Clinic in order to ensure the safety of
all patients. There are additional benefits for the implementation of this HFMEA project. The data collected through the
PDA system, such as blood transport time, blood injection time, and blood returned rate proved to be useful in evaluating
the efficiency of the blood transfusion process. The users (the satisfaction was 34.7%) felt the improvements were helpful
in the handling of their daily work.
3.
RESULTS
3.1. Data Collection
The period allotted for data collection was from 2005 to 2009. A total of 58,933 blood transfusion processes were
performed during this investigation (13,261 in 2005, 12,013 in 2006, 11,306 in 2007, 10,795 in 2008 and 11,558 in 2009).
The number of adverse events in these blood transfusion procedure was 19 (4 in 2005, 2 in 2006, 11 in 2007, 0 in 2008 and
2 in 2009) for a defect rate of almost 0.032%.
3.2. Failure Modes and Analysis of Causes
The HFMEA team analyzed the blood transfusion process in detail. It was able to identify eight possible failure modes
(see Figure 2). In addition, the team analyzed the severity and probability of each failure mode and determined the relevant
recommendation actions. Table 1 illustrates the deployment of the decision tree to determine whether the recommended
5
actions are necessary or not.
1
2
3
4
5
6
Doctor’s
Order
Blood
Preparation
Blood
Cross-matching
Blood
Ordering
Blood
Delivery
Blood
Transfusion
Failure Modes
1. 2A(1)-The patient is
not the person who
received the doctor’s
order
2. 2B(1)-The blood does
not match that which
appears on the written
label
3. 2C(1)-The inspection
Failure Modes
1. 3A(1)-The inspection
staff did not correctly
Failure Modes
1. 4A(1)- Phone
conversation regarding
verify the information
the required blood was
Failure Modes
1. 5C(1)-Taking too
much time to
transport blood
product
unclear
Failure Modes
1. 6A(1)-The nurse did
not correctly verify
the doctor’s order
2. 6C(1)-Checking of the
patient’s identity was
not complete
materials are
incomplete
Figure 2. Failure Modes of Blood Transfusion ProcesS
By brainstorming, the team summarized that there were 18 possible causes that could result in these eight failure modes.
In addition, the analyzed results of the decision tree showed that there were nine possible causes that needed to be
addressed. The team decided to submit six of recommendation actions to hospital management for approval. Finally, five
out of the six recommendation actions were selected for initial implementation of improvement campaigns.
6
Table 1. HFMEA Analysis of the Blood Transfusion Process
HFMEA Step 4 – Hazard Analysis
N
Y
No
Measure
No
N
Yes
N
Y
No
N
N
Yes
Control
Fr.
N
16
N
N
Yes
Control &
Eliminate
Oc.
Fr.
Yes
12
N
N
Yes
Control &
Eliminate
Fr.
Ca.
The nurses poured the blood
into the wrong test tube
Ca.
2B(1)
b
Mo.
2B(1)
a
The nurses stuck the wrong
label to the tube
1. They labeled the wrong test
tube
2. They attached the wrong
blood requisite form
3. They wrote incorrect data on
the label
N
Outcomes
Action
Responsible
16
2B(1) The blood does not
match the description on
the label of tube
Y
N
Action Type
(Control,
Accept,
Eliminate) or
Rationale for
Stopping
Person
4
Proceed?
The identifications in the
bracelet were not clear
Detectable?
2A(1)
d
12
Existing Control
Measure?
Hazard Score
The nurse did not see the
contents of bracelet well
Single Point
Weakness?
Probability
Occ.
Un.
2A (1)
c
Oc.
Severity
Cat.
Mi.
N
The nurses did not listen well
Mi.
2
2A(1)
b
Ca.
Y
The patient was inarticulate
Ca
.
Re
.
2
2A(1)
a
2A(1) The patient is not the
person who received the
doctor’s order
2C(1) The inspection materials
are incomplete
12
Ca.
Potential Causes
Un.
Failure Modes:
First evaluation failure
mode before determining
potential causes
HFMEA Step 5- Identify Actions and Outcomes
8
N
N
Yes
7
1. Enforcement of nurse education training
2. Ask the nurse to do thorough verification
of vital information
The incorrect
rate of
identifying
patient
Nurse department
1. Modify the standard operation procedure
(SOP) of blood transfusion
2. Retraining the nurses
3. Verify the patient’s bracelet, blood testing
form, and preparation of blood
transfusion label through the PDA
The incorrect
rate of label
1. Nursing
department
2. Blood
transfusion
committee
3. Medical
information
center
Same as above
Same as above
Same as above
4A(1) Phone conversation
regarding the required
blood was unclear
4A(1)
a
The unit requiring blood did not
clearly articulate the essential
information about the required
blood
Mo.
3A(1) The inspection staff did
not correctly verify the
information
No
2
N
No
2
N
No
N
N
Yes
16
N
N
Y
8
N
N
Yes
8
N
N
8
Yes
Eliminate
Control
Eliminate
Control
Control
Outcomes
Action
Measure
1. Modify the standard operation procedure
(SOP) of blood transfusion (double-check
and sign)
2. Retraining the nurses
3. Verify the specimen through the PDA
before sending it to the blood bank
Responsible
Action Type
(Control,
Accept,
Eliminate) or
Rationale for
Stopping
Person
Proceed?
Detectable?
Existing Control
Measure?
Single Point
Weakness?
Hazard Score
Probability
Fr.
Re.
The inspection staff received
the specimen but did not notice
the incorrectness
N
Un.
Mi.
2C(1)
d
2
Un.
The specimen was losing during
the transport
8
Fr.
Mo.
Mo.
2C(1)
c
Ca.
The nurse did not know that the
blood transfusion request form,
the blood testing form, and the
specimen were all required
Mo.
2C(1)
b
Mi.
2C(1)
a
The nurses did not verify the
data of the specimen and
dispatched such to the blood
bank
HFMEA Step 5- Identify Actions and Outcomes
Fr.
Potential Causes
Fr.
Failure Modes:
First evaluation failure
mode before determining
potential causes
Severity
HFMEA Step 4 – Hazard Analysis
The incorrect
rate of
checking
blood
transfusion
data
1. Nursing
department
2. Blood transfusion
committee
3. Medical
information
center
1. Use of PDA to scan blood bag, blood
transfusion request form, blood release form
before blood is released
2. Printing the label to be stuck on the blood
bag
Discrepancy
rate of
specimen
and label
1. Blood transfusion
committee
2. Blood bank
3. Medical
information
center
1. Cancellation of the order blood by
telephone
2. Ordering blood on-line
Incorrect
rate of blood
product
1. Blood bank
2. Nursing
department
3. Medical
information
center
HFMEA Step 4 – Hazard Analysis
Proceed?
Control
Mi.
Fr.
It took too much time to wait
for the elevator
Mi.
Fr.
4
5C(1)
b
The nursing staff spent too
much time for transporting
Mi.
Fr.
4
Oc.
9
Oc.
Ma.
The nurse did not indeed check
the doctor’s order
N
No
N
No
N
No
N
N
Yes
9
N
N
Yes
Control
Re.
identity was not complete
3
Fr.
6C(1) Checking of the patient’s
Ma.
The nurse was too tired to check
the data
Oa.
2.
6A(1)
b
16
N
Fr.
Oa.
The nurses did not follow SOP
when they verified the blood
transfusion data
16
Modify the standard operation
procedure (SOP) of blood
transfusion (double-check the
doctor’s order )
Retraining the nurses
Incorrect rate of
verifying
doctor’s order
Nursing
Department
No
N
N
Yes
1.
6C(1)
a
As above
of inspection
1.
6A(1)
a
Incorrect rate
Responsible
Detectable?
Yes
Person
Existing Control
Measure?
N
Measure
report
5C(1)
a
6A(1) The nurse did not
thoroughly verify the
doctor’s order
N
Outcomes
Action
Same as above
4
transport blood product
Single Point
Weakness?
8
Ma.
5C(1) Taking too much time to
Hazard Score
concentrate
Probability
The blood bank staff did not
Fr.
4A (1)
b
Severity
Potential Causes
Mo.
Failure Modes:
First evaluation failure
mode before determining
potential causes
HFMEA Step 5- Identify Actions and Outcomes
Action Type
(Control,
Accept,
Eliminate) or
Rationale for
Stopping
N
N
Yes
Eliminate
Control
2.
3.
Modify the standard operation
procedure (SOP) of blood
transfusion
Retraining the nurse
Verification the label on the blood
bag by the PDA
Ca.: catastrophic; Ma.: major; Mo.: moderate; Mi.: minor; Fr.: frequent; Oc.: occasional; Un.: uncommon; Re.: remote.
9
Incorrect rate
of blood
transfusion
1. Nursing
department
2. Blood
transfusion
committee
3. Medical
information
center
3.3. Recommendation Actions
Action plan 1: online blood product ordering system
To reduce transcription errors and mistakes caused by miscommunication on the telephone, our team proposed the
improvement action by establishing an online blood product ordering system, which was completed in April, 2008. The
blood-requiring unit is asked to send the request of blood products, including blood type and transfusion time through
the system. After the request is submitted, the system will simultaneously message the blood bank via personal
handyphone system (PHS).
Action plan 2: adhere patient information label on the individual blood product package.
To avoid the blurred identification of the blood product package, the blood bank staff used a water-proof printed,
instead of a hand-written patient/blood information sticker, which displays the patient name, blood type, bar code, and
date. The printed stickers are placed on both the blood product package and the plastic bag, which is wrapped outside
of the package.
Action plan 3: employ a PDA to prevent patient identification error.
This action used a PDA (Team Pad 500G, FUJITSU, Kawasaki, Japan; work on Windows CE, .NET platform.) to
match the information on a patient’s wrist band (bracelet bar code) and the sticker on blood product package. Before
the transfusion, the nurse uses PDA to confirm patient identification by scanning the patient’s wrist band as well as the
sticker on blood product package.
Action plan 4: retrain and test of blood transfusion system users
To be aware of the knowledge and techniques in operating the new blood transfusion process, the blood transfusion
committee retrained staff and requested them to be re-qualified. At the end, a total of 490 staff was participated in the
new education course and the re-qualification exams showed the understanding of new process were 92.8% for doctors,
95% for nurses, and 97% for blood bank staff.
Action plan 5: revise the standard operation procedures (SOP) of blood transfusion
The blood transfusion committee revised the SOP of blood transfusion process and adopted the latest changes of the
whole transfusion processes including the PDA Sentry Robot, the online blood product ordering system, and the use of
patient/blood information stickers for the blood product package.
4.
DISSCUSSION
Although HFMEA shows the effectiveness in identifying and preventing the possible adverse events, it still required
certain conditions to succeed. Strong support from the top management of the hospital is the most critical term. In
addition, the identical faith and language of all related members also direct affect the achievement of the HFMEA
project. Last but not least, the skills of implementing HFMEA can be a prerequisite to complete the project.
HFMEA is a valuable method for proactive risk analysis of the blood transfusion process. It helped the research
hospital in identifying potential failures in the blood transfusion and in understanding the importance of evaluating the
process from a systematic point of view. A systematic view permits a more comprehensive evaluation of the
weaknesses and failure modes of the system before any adverse outcomes occur. Despite the extensive investment of
money, time, and manpower, the method ensures a safer medical environment for patients and staff. Many researches
have illustrated the efficiency of HFMEA and its favorable effect on a variety of medical processes ((Esmail et al.,
10
2005); (Linkin et al., 2005); (Van Tilburg et al., 2006); (Habraken et al., 2009)).
There may have many opportunities for errors to show at a number of critical points in the blood transfusion chain,
starting with the doctor’s order, blood preparation, blood cross-matching, blood ordering, blood delivery, and final
blood transfusion. To reduce those opportunities of adverse events in the blood transfusion chain, our team addresses
several preventing actions, for example, the online blood product ordering and a PDA sentry robot to identify the
patients. Those actions are responded to different researches which discussed the possible error occurring in the blood
transfusion process. Stainsby ea al. (2005) indicated that weal links are the critical problem in the blood transfusion
chain. Saxena et al. (2004) demonstrated the poorly defined monitoring systems would be the cause of the adverse
events. The improvements made over past 1.5 years appear to have been quite effective in preventing transfusion errors
and reducing the number of near-misses. The result of this study illustrated the effective of the HFMEA and the
contribution of improving the patient safety.
5.
CONCLUSION
HFMEA proves to be an effective methodology to analyze and re-engineer healthcare processes, especially for
complex processes that are potentially risky to patient. By using HFMEA in this study we identified several critical
failure modes that are likely to threat patient’s safety. We have successfully introduced information technology to
improve the whole blood transfusion process.
The HFMEA analysis of this study proves that information technology can effectively reduce the human errors. The
linkage of the online blood product ordering system with HIS provides immediate access to blood-related patient
information to secure the correctness of patient identification. Moreover, the PDA system also can prevent incorrect
patient identification at the last step of blood transfusion at bedside.
6.
ACKNOWLEDGEMENT
This project was presented in the 2009 International Society for Quality in Health Care meeting, Dublin, Ireland.
7.
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