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Process Redesign for Improving the Traceability of Medical
instruments at a Hospital: A proposal for RFID
Technologies
Afrooz Moatari-Kazerouni1
and Ygal Bendavid2
1,2
Department of Management and Technology, Université du Québec à Montréal (UQAM),
Canada
Moatari_Kazerouni.Afrooz@courrier.uqam.ca; Bendavid.Ygal@uqam.ca
Abstract. Since mid-2000s hospitals have begun implementing Radio Frequency
Identification (RFID) technology in order to improve their operations management.
This paper aims to explore the potential of RFID technology in improving the
traceability of medical instruments in a hospital environment. A case study is
conducted at a hospital in Montreal, Canada and the business process reengineering
(BPR) approach is used to assess realistic potential of the technology. Specific key
performance indicators (KPIs) are identified and eventual issues related to
implementation of the redesigned processes is discussed.
Key words: business process redesign, traceability, hospitals, RFID technologies
1 Introduction
Traceability is defined as “the ability to track forward the movement of products through
specified stages of the supply chain and trace backward the history, application or
location of products under consideration” [11]. The adoption of novel automated
identification technologies such as radio-frequency identification (RFID) technologies
have attracted the attention of professional and scientific community in various domains
including food traceability such as dairy product [1], cattle/beef [8], or aquaculture [15],
as well as in manufacturing environments for job-shop scheduling [7] or in healthcare
environment were the technology is used for tracking and tracing of medical supplies,
high value products [2], mobile assets, patients, and hospital staff [3]. In the hospital
setting, RFID enables automatic identification and tracking of products, people, and assets
which result in real-time visibility and improved efficiency in the delivery of services [9]
[19-20].
On one hand, ensuring “products” tracking and tracing at hospitals allows for
increasing the efficiency of operations such as logistics and quality management
processes, complying with regulatory requirements, guidance on product recall, as well as
supporting safety of patients, etc. On the other hand, ensuring traceability can be a
challenging task. The organization should have a system to uniquely identify “products”,
and collect, store, manage, and share information about them with the key stakeholders of
the processes.
This paper aims to explore the potential of RFID technology in improving traceability
of medical instruments at a hospital environment. The rest of this paper is organized as
following. In Section 2, the specific problem and research objectives are presented. RFID
technologies are then presented in more details in section 3. In section 4, the
methodological approach of the research is presented to clarify data collection and
analysis within a case study context. In section 5, a high level analysis of the case is
presented to better estimate the impact of RFID technology on the traceability process.
The paper concludes in section 6 with the future research avenues.
2 Problems and Objectives of the Research
Deploying real-time location systems (RTLS) to manage high-value mobile assets in
hospitals drove the initial momentum in the adoption of RFID technologies. In recent
years, hospitals have implemented a broad range of RFID applications related to supply
chain and condition monitoring, security and access control, patient safety management
etc. [4] [9] [19]. Numerous business cases are documented on the most renowned RFID
web site: RFID Journal [http://www.rfidjournal.com/healthcare]. Among the cited
benefits, increased patient satisfaction, improved business processes and workflow,
decreased equipment costs, improved inventory management, and decreased overall
operating costs are often reported [18].
Although numerous implementations of RFID enabled RTLS have been conducted at
hospital settings [3] [12], the reality of RFID adoption in healthcare is far behind earlier
expectations [19]. Beside cost which still is a significant issue [10] [20], barriers to RFID
adoption can be classified as (i) technological; (ii) data management, security and privacy;
and (iii) organizational and financing issues. It is interesting to see that “designing and
implementing RFID-enabled healthcare processes” is ranked as one of these key issues
[10]. Generally, implementing the RFID-enabled system is done in conjunction with the
redesign of processes as well as the design of a facility layout; since the early design of a
facility layout is critical as it directly and indirectly results in higher efficiency of the
material flow and control [14].
Since RFID is an enabler of efficient traceability, the main objective of this research is
to explore the realistic potential of this technology for improving the traceability of
surgical instruments. More specifically, this research focuses on the flow of medical
equipment between the Central Sterilization Department (CSD) and operating rooms (OR)
at a hospital in Montreal, Canada.
3 RFID Technologies in Hospitals
An RFID system is a multi-layer system composed of hardware and software that
integrates into back-end information systems (see Fig.1). This first layer allows the
automatic identification of tagged objects (e.g., patients, instrument sets) by automatically
capturing RFID tags ID. Usually, passive Ultra High Frequency RFID tags (powered by
the reader RF) are used in logistics applications due to their relative low cost and great
performance (e.g., read range up to few meters, multi-tag read). Semi-passive tags,
equipped with embedded sensors (powered by a battery), can be used in applications such
as cold chain logistic management. Active tags, on the other hand, are often used for
RTLS applications since they have a read range up to few hundred meters [4].
Fig. 1. RFID system - adapted from [2]
Various types of RFID readers can be used to capture data from RFID tags signal. As
such are: fixed readers (e.g., RFID portals for choke point reads or zone monitoring),
portable readers (i.e., handheld “guns” used for inventory management), and mounted
readers (e.g., on carts as a mobile tracking solution). The data registered by the RFID
readers is then transferred to data management layer using a communication network.
The second layer is the data management layer, composed of (i) a RFID middleware,
which is used to process and distribute RFID based data into (ii) specific back-end
Data 
Management
Data capture and identification of 
«objects» & communication
Hand held RFID readersMounted RFID readers
Fixed  RFID readers & 
Antennas
Active/hybrids  
RFID Tags
Semi‐passive  
RFID Tags
Passive  RFID Tags
Bar codes (labels, 
KeyDots, direct 
part marking) 
Patients
Logistics units (e.g. 
surgical instruments, 
crates, carts, etc.)
Mobiles 
assets 
Patients, 
staff, mobile 
assets
Sensitive 
products (e.g. 
vaccines)
Units identification
Units data capture
Communication Networks 
E.g., Wired and wireless LAN (Wi
Fi, 802.1x access points)
Back end Hospital Information Systems (HIS)
ERP
CMS
E.g., Enterprise
Resource Planning
system (ERP); Clinical
management system
RFID Middleware platform
Stand alone platform
or EIS modular option
(e.g., sensor-driven /
real-time event
processing engine)
Antennas and location 
identifiers (tag sensors, 
exciters)
hospital systems (i.e., Enterprise Resource Planning systems-ERP, Clinical Management
System-CMS), where this information is managed to improve the decision making
process.
4 Research Methodology: Using a Case Study Approach
RFID-enabled projects in the healthcare context is an emerging phenomenon in complex
environments [17], which involve numerous stakeholders, with references to change
management as well as ethical and legal considerations [13]. Therefore, the case study
approach was selected as the preferred research strategy to facilitate the identification of
the main concepts involved and to investigate the problem “within its real-life context”
[21]. The case study was conducted at a hospital, where the underway construction of a
new building will be the new home for the CSD and OR departments. This relocation
brought up the opportunity of improving the flow of items (e.g., surgical instruments)
from CSD to OR. Using case carts for transferring items as well as implementing a
traceability system were considered. The business process re-engineering (BPR) approach
was adopted to identify the impact of RFID technology on selected surgical equipment
tracking and tracing processes (see Fig. 2). BPR is an approach that focuses on value-
added business processes [6] and how an organization should operate to better meet the
needs of its customers.
This approach involves discovering how business processes currently operate, how to
redesign these processes to improve the efficiency, and how to implement the process
changes to gain competitiveness [5]. As presented in Fig. 2, this research followed four
steps which are elaborated in the following sections. Within this paper we focus on steps 1
and 2, namely understanding specifications of the current process and modeling them,
whereas the main objective is to redesign the process to include the traceability system as
well as the case cart practice.  
Steps 1 and 2: Understanding current business process and modeling As-Is process: In
order to map and analyze the current process, the flow between CSD and OR was studied
in detail. Information in regards to the stakeholders of the process, as well as the
activities, inputs, outputs, control points, and the information flow within the IT system of
the hospital was gathered. The main sources of data collecting were (i) on-site
observations, (ii) open ended interviews with project managers, head manager of the CSD
and OR, employees from CSD, and managers responsible for material management and
purchasing, and (iii) complementary documents such as internal business analyses. The
“As-Is” process flow between CSD and OR in the actual building was then mapped,
analyzed, and served as a basis for the “To-Be” analysis. This exercise supported
proposing scenarios (in step 3) by recognizing the changes that come with relocating these
departments to the new building, as well as the requirements for including the traceability
system (e.g., IT system and interfaces). Since the emphasis of this research was on
processes related to the traceability of medical items and the case cart incorporation, new
steps in the process were considered.
Step 3: Performing a To-Be analysis: A first scenario of a process flow was proposed
and mapped between CSD and OR in the new building. In this case, the existing
barcoding system is used for tracking and tracing of crates and instrument sets throughout
the process. This initial mapping is discussed in section 5 as it constitutes the basis of
comparison with alternative options including RFID enabled traceability. In order to
evaluate the performance of designed processes, different control points were identified
and process owners were asked to identify relative key performance indicators (KPIs). As
further research to this paper, each scenario will be modeled, measured and analyzed by
using Arena as a discrete event simulation software.
Fig. 2. BPR approach for this research
Step 4: Implementing and measuring: The “what if” analysis results of the simulations
will lead to decisions regarding the selection of processes with the highest performance.
Additionally, a trade off analysis will need to be performed to weight decisions by taking
into account factors such as (a) the marginal contribution on the process performance of
Perform What‐if Analysis
Measure, simulate and analyze 
(prospective) alternatives
Model the future processes
TO‐BE Analysis
FEEDBACK
Model the current 
processes (traceability of 
equipment)
AS‐IS Analysis
Select one scenario, manage 
transition (pilot project ) 
and monitor performance
Implementation & 
measurement 
‐ Objectives
‐ Stakeholders
‐ Inputs/outputs
‐ Control
‐ Information systems
‐ Performance monitoring 
frameworks
‐ KPIs
‐ Stakeholders/Roles
‐ Information systems
Understand the current 
hospital’s business 
processes
‐ Simulation Tools (Arena)
‐ Business process tools (Visio; Aris/Software AG)
Data gathering
Using different options
‐ Manual data capture
‐ 1D and 2D bar codes (item level)
‐ RFID technologies (item level)
‐ Hybrid options (RFID + bar code)
each technological scenario, (b) the total cost of ownership (investment costs,
identification/tagging costs, operations cots), and (c) the probability of technical success.
Therefore, the technical feasibility of the proposed solutions will need to be validated and
the business process robustness be tested. For this purpose, a prototype of an RFID
enabled traceability system will be (i) built and tested in a RFID lab, and then (ii)
implemented onsite as a pilot project. The selected scenarios/process flows will constitute
the guideline for tagging and tracking of designated assets (crates, instruments). Finally,
its performance will be compared with the alternative processes (e.g., using barcodes).
5 Analysis: Redesigning Traceability Process at the Hospital
5.1 A Scenario of Traceability Process
Since hospital managers are mainly interested in leveraging on actual barcoding systems,
a scenario was proposed and designed, based on the original “As-Is” tracking and tracing
process of instrument sets and crates between CSD and OR. In this scenario, existing uni-
dimensional 1D barcodes are used for the traceability at the case cart level (used for
transporting instruments) throughout the process and two-dimensional (2D) data matrix
barcodes are used for the preparation of instruments sets (see barcoding system in Fig. 3
and redesigned process in Fig. 4). A further “What-If RFID technology was used”
analysis will be performed for a better understanding of the marginal contribution of using
this technology over the existing one.
Fig. 3 Barcode system used for tracking crates and instrument sets
Fig. 4 presents the macro processes related to case cart preparation by CSD, the picking
process at sterile core and how the instruments are treated inside the operating theatres,
the reprocessing of soiled instruments, as well as replenishment activities for CSD and
sterile core storage. For an increased granularity, each main process was also decomposed
into specific sub processes and activities (not presented in this paper).
In order to identify all the locations and stakeholders involved in the process, the layout
of new CSD department was separated in different zones: soiled case cart zone, soiled
zone (decontamination zone), clean zone (assembly zone), sterile zone, and storage zone
(carousel and shelving). Similarly, the OR was divided into three sections: OR general
management, operating theatres, and sterile core. Additionally, all the scanning points
(and related update of information in the hospitals ERP system) have been specified. The
tracking and tracing of instrument sets/trays is done (i) during picking in the CSD storage
zone, (ii) inside the operating theatre and before using the instruments in the surgery, and
(iii) during the reprocessing of soiled instruments and re-assembling the instrument sets.
The process starts once a CSD employee receives a preparation list based on the
surgeries planned for the next day. He picks the items from storage and send the case carts
to sterile core where an OR attendant will complete the case cart -and so on.
Using 1D barcodes to identify and track crates and 2D data matrix barcodes to identify
the list of instrument sets throughout this process was identified by key respondents as a
way of (i) reducing errors in assembling the instrument sets, (ii) linking patients with
instrument sets used in specific surgeries, (iii) locating instrument sets at each point of
time, and (vi) keeping records of cleaning and disinfection cycles. Although this visibility
at the crate level is interesting, it does not provides a full accountability for every surgical
instrument and every step of the process.
This is why other scenarios were envisioned, firstly by considering a different level of
tagging (barcodes at the crate and instrument level) and then by considering different
technologies (RFID, hybrid RFID/barcode solutions). For instance, in one scenario, the
engraved numbers of 2D barcodes (permanent marking using micro-percussion or
KeyDots- labels applied directly to an instrument’s surface), could be used similar to a
license plate for tracking individual surgical instruments beyond the crate/tray level.
While these solutions are highly reliable, reading each individual instrument (which
requires to correctly align the laser) takes few seconds per item, leading to limited
productivity gains. Since each tray contains an important amount of instruments, each
time that the instruments need to be scanned this leads to a time consuming non value
added activity. Therefore, respondents suggested to identify and match individual surgical
instruments with the crate during the preparation of the set at the CSD and use barcodes at
the crate level for the following processes.
Fig. 4 Process mapping of redesigned process – scenario 1
Traceability Throughout the Case Cart Preparation Process – High Level Mapping
OR‐
Sterile Core
OR‐General 
Management
CSD‐Soiled Case 
Cart Zone
CSD‐Clean ZoneCSD‐Sterile ZoneCSD‐Storage Zone
Material Management 
and Purchasing
OR‐
Operating Theatre
CSD‐Soiled Zone
Legend 
Determine 
the surgery 
list for next 
day
Get a case 
cart
Pick items 
from carousel 
and shelves
Transport case cart 
to OR‐sterile core 
via clean elevators
Take the cart inside 
operating theatre
Surgery 
starts
Pick rest of 
items from 
Sterile Core
Surgery 
ends
Nurse put Soiled items 
In case cart and leave it 
in Soiled Holding Zone
OR attendant transport 
case cart to CSD via 
soiled elevator
Empty the 
case cart
Wash the soiled 
case card in 
washing machines
Decontaminate 
and wash the 
intruments
Park the 
soiled 
case cart
Case carts 
are ready 
to be used
Assemble the 
instrument 
sets
Sterilize 
instrument 
sets
Restock 
carousel 
and shelves
Instruments 
are ready to 
be used
Opera 
Carousel 
System
Order based on 
the purchasing 
demands
Receive 
ordered 
items
Record and 
de‐box 
items
Restock 
carousel 
and shelves
Items 
ready to 
be used
ERP 
system: 
Logibec 
Restock the 
sterile core 
storage
Items are 
ready to be 
used
Park the case 
cart near the 
operating 
theatre
Items should 
be stored in 
CSD?
Transport 
items to CSD
Transport items to 
sterile core
NO
Preparing 
case cart
Operating 
Theatre and 
Sterile Core
Reprocessing 
of soiled 
instrum
ents
M
aterial 
M
anagem
ent
Once a surgery list 
is planned, A 
preparation list 
request Is 
transferred to CSD 
(about) 24hrs in 
advance; at 9pm of 
the day before 
surgery by the 
latest
The preparation of 
case carts starts 
during the night shift 
(10pm‐6am). When 
the night shift 
employees arrive, 
the CSD supervisor 
provides the printed 
preparation list.
OROR
CSDCSD
MMMM
A,B
Responsible from OR (nurse, 
team leader…)
Sterilization department 
employee
Responsible from material mgt 
(store keeper, employee…)
Purchasing demand
CSD: Central Sterilization Department
OR: Operating Room
ORMS: OR Management System
Flow of information In ERP 
Beginning/end of a process
Employee/system interaction
Transport of items or case cart
Operation 
Decision 
Links between high level processes 
and detailed level processes
Links between different sections 
of detailed level processes
Print & attach 
preparation 
list to each 
case cart
Scan the cart/s 
(barcode on the 
preparation list)
Instrumental 
Scan the case 
cart and 
instrument sets
Opera/
Instrumental
Scan the 
instrument trays 
and the case cart
Instrumental 
Scan the tray for 
opening the 
assembly recipe 
Instrumental 
Generate 
production label & 
attach to the set
Scan the production 
label (recording which 
sterilization machine)
Instrumental 
Record 
itemsCSDCSD
CSDCSD
CSDCSD
OROR OROR
OROR
OROR OROR
MMMM
CSDCSD
CSDCSD
CSDCSD
CSDCSD
CSDCSD
CSDCSD
MMMMMMMM
Yes
5.2 “What- If” RFID Technology Was Used?
A “What- If” analysis has started to explore the marginal contribution of using RFID
technology over the existing system.
One envisioned impact of using RFID is to increase the automation of internal logistic
processes for the tracking of equipment while progressing through all stages of the
processes.
With RFID enabled bulk-reading of tagged instruments, a whole tray/crate can be
automatically loaded into the CMS, eliminating non value added activities at (a)
preoperative stage (e.g., preparation of the crates and related time spent at CSD storage
zone for scanning items), (b) intraoperative stage (e.g., verification of crates before
surgical interventions and related time spent at the OR sterile core and inside the
operating theatre) (c) postoperative stage after usage by the OR (i.e., tracking instruments
through the sterilization process and ensure the compliance with sanitary regulations).
Additionally, enabling identification at the instrument level prevent the loss of
instruments who might be left aside during one operation. In the past years, some RFID
suppliers started to propose surgical instruments traceability solutions that leverage on
RFID technology (e.g., Xerafy and Caretag, Haldor Advanced Technologies). For
instance, Xerafy developed a series of highly resistant (IP68), autoclavable, FDA
compliant, small UHF RFID ceramic tags that can be mounted on individual metal
surgical instruments (i.e., Dash-On XS; Dot-On XS tags; Dash-iN XS; Dot-iN XS for
instruments or MicroX II-Autoclavable Version and Roswell tags for surgical Trays).
Thanks to the standards regulating passive RFID UHF technologies, these tags can be
read with any RFID equipment from different vendors in the industry such as
Zebra/Motorola, Alien technology or impinj. For the Middleware solution, vendors like
Caretag have developed specialized modular traceability solutions for the management of
surgical equipment. Additionally, actual players in hospitals are leveraging on their own
solutions to enable RFID integration. While the business logic is the same, the data
capture is radically different with RFID.
Conversely, while using RFID for the tracking of instruments is interesting in terms of
process efficiency, embedding or attaching RFID tags on instruments requires specific
competencies and equipment (e.g., covering the tag with FDA-approved USP Class VI
epoxy resin to secure the tag in place and ensuring the right tag placement to maximize
performance). While this step can be outsourced to specialists, it was identified as an issue
in the project, considering (a) the important amount of individual equipment to be tagged,
(b) the time required to identify and match each item in the data base, and (c) the upfront
investment costs for RFID hardware infrastructure, middleware platform configuration
and integration, project management, etc. There is no doubts that potential benefits need
to be properly evaluated for accurately measuring operations savings and building a
business case.
6 Conclusion and Further Research
This paper raised the importance of using simulation software such as Arena as a
“process analyzer” to efficiently compare the “What-If” envisioned scenarios. As further
steps to this research, modeling of different scenarios for the designed process will need to
be done. Additionally, in order to measure the performance of the traceability process,
control points and relative KPIs need to be identified by process owners as well as by
looking at existing logistic performance frameworks [16]. In this research some KPIs are
already specified and will constitute the basis for further analysis. The first KPI is
obviously related to the productivity of the process and its “responsiveness”, by analyzing
the activities related to the “fulfillment cycle time”, in particular by measuring the
“average time for case cart preparation”, i.e., the time spent to prepare the case cart at
CSD and sterile core. In fact, the time factor will be measured elsewhere in the process
wherever there is a time consuming activity that can be reduced or eliminated with RFID
technology – such as “average time for” counting/ verifying/ validating/ etc.
The second KPI is related to the “reliability” of the process by analyzing the order
fulfillment performance, in particular with measuring the “accuracy of case cart
preparation”, i.e., the % crates that are delivered according to demands from OR (item
accuracy and quantity accuracy). This is of a particular importance since any discrepancy
between the preparation list and the instruments delivered will have an impact on the
productivity of the process and will involve re-processing the orders. Of course, the
situation might be worst if the discrepancy is not detected before surgery where
instruments are need immediately.
Other KPIs may also be of interest for other departments such as material management
and purchasing in charge of renewing instruments, as well as the CSD storage (on
carousel and shelving). For instance, the status of each instrument (in its life cycle) and
the “inventory availability” may be measured for ensuring high quality in service delivery
without creating excess inventory of instruments.
Since the main objective of this research was to explore the realistic potential of RFID
for improving the traceability of medical equipment, the next steps will be (i) proposing a
redesigned flows that facilitates the traceability processes of case carts and/or individual
instruments between CSD and ORs, (ii) identifying the “best case” scenarios, and (iii)
realistically assessing the potential of RFID technologies for improving this process.
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Bpr at the hospital

  • 1. Process Redesign for Improving the Traceability of Medical instruments at a Hospital: A proposal for RFID Technologies Afrooz Moatari-Kazerouni1 and Ygal Bendavid2 1,2 Department of Management and Technology, Université du Québec à Montréal (UQAM), Canada Moatari_Kazerouni.Afrooz@courrier.uqam.ca; Bendavid.Ygal@uqam.ca Abstract. Since mid-2000s hospitals have begun implementing Radio Frequency Identification (RFID) technology in order to improve their operations management. This paper aims to explore the potential of RFID technology in improving the traceability of medical instruments in a hospital environment. A case study is conducted at a hospital in Montreal, Canada and the business process reengineering (BPR) approach is used to assess realistic potential of the technology. Specific key performance indicators (KPIs) are identified and eventual issues related to implementation of the redesigned processes is discussed. Key words: business process redesign, traceability, hospitals, RFID technologies 1 Introduction Traceability is defined as “the ability to track forward the movement of products through specified stages of the supply chain and trace backward the history, application or location of products under consideration” [11]. The adoption of novel automated identification technologies such as radio-frequency identification (RFID) technologies have attracted the attention of professional and scientific community in various domains including food traceability such as dairy product [1], cattle/beef [8], or aquaculture [15], as well as in manufacturing environments for job-shop scheduling [7] or in healthcare environment were the technology is used for tracking and tracing of medical supplies, high value products [2], mobile assets, patients, and hospital staff [3]. In the hospital setting, RFID enables automatic identification and tracking of products, people, and assets which result in real-time visibility and improved efficiency in the delivery of services [9] [19-20]. On one hand, ensuring “products” tracking and tracing at hospitals allows for increasing the efficiency of operations such as logistics and quality management processes, complying with regulatory requirements, guidance on product recall, as well as supporting safety of patients, etc. On the other hand, ensuring traceability can be a
  • 2. challenging task. The organization should have a system to uniquely identify “products”, and collect, store, manage, and share information about them with the key stakeholders of the processes. This paper aims to explore the potential of RFID technology in improving traceability of medical instruments at a hospital environment. The rest of this paper is organized as following. In Section 2, the specific problem and research objectives are presented. RFID technologies are then presented in more details in section 3. In section 4, the methodological approach of the research is presented to clarify data collection and analysis within a case study context. In section 5, a high level analysis of the case is presented to better estimate the impact of RFID technology on the traceability process. The paper concludes in section 6 with the future research avenues. 2 Problems and Objectives of the Research Deploying real-time location systems (RTLS) to manage high-value mobile assets in hospitals drove the initial momentum in the adoption of RFID technologies. In recent years, hospitals have implemented a broad range of RFID applications related to supply chain and condition monitoring, security and access control, patient safety management etc. [4] [9] [19]. Numerous business cases are documented on the most renowned RFID web site: RFID Journal [http://www.rfidjournal.com/healthcare]. Among the cited benefits, increased patient satisfaction, improved business processes and workflow, decreased equipment costs, improved inventory management, and decreased overall operating costs are often reported [18]. Although numerous implementations of RFID enabled RTLS have been conducted at hospital settings [3] [12], the reality of RFID adoption in healthcare is far behind earlier expectations [19]. Beside cost which still is a significant issue [10] [20], barriers to RFID adoption can be classified as (i) technological; (ii) data management, security and privacy; and (iii) organizational and financing issues. It is interesting to see that “designing and implementing RFID-enabled healthcare processes” is ranked as one of these key issues [10]. Generally, implementing the RFID-enabled system is done in conjunction with the redesign of processes as well as the design of a facility layout; since the early design of a facility layout is critical as it directly and indirectly results in higher efficiency of the material flow and control [14]. Since RFID is an enabler of efficient traceability, the main objective of this research is to explore the realistic potential of this technology for improving the traceability of surgical instruments. More specifically, this research focuses on the flow of medical equipment between the Central Sterilization Department (CSD) and operating rooms (OR) at a hospital in Montreal, Canada.
  • 3. 3 RFID Technologies in Hospitals An RFID system is a multi-layer system composed of hardware and software that integrates into back-end information systems (see Fig.1). This first layer allows the automatic identification of tagged objects (e.g., patients, instrument sets) by automatically capturing RFID tags ID. Usually, passive Ultra High Frequency RFID tags (powered by the reader RF) are used in logistics applications due to their relative low cost and great performance (e.g., read range up to few meters, multi-tag read). Semi-passive tags, equipped with embedded sensors (powered by a battery), can be used in applications such as cold chain logistic management. Active tags, on the other hand, are often used for RTLS applications since they have a read range up to few hundred meters [4]. Fig. 1. RFID system - adapted from [2] Various types of RFID readers can be used to capture data from RFID tags signal. As such are: fixed readers (e.g., RFID portals for choke point reads or zone monitoring), portable readers (i.e., handheld “guns” used for inventory management), and mounted readers (e.g., on carts as a mobile tracking solution). The data registered by the RFID readers is then transferred to data management layer using a communication network. The second layer is the data management layer, composed of (i) a RFID middleware, which is used to process and distribute RFID based data into (ii) specific back-end Data  Management Data capture and identification of  «objects» & communication Hand held RFID readersMounted RFID readers Fixed  RFID readers &  Antennas Active/hybrids   RFID Tags Semi‐passive   RFID Tags Passive  RFID Tags Bar codes (labels,  KeyDots, direct  part marking)  Patients Logistics units (e.g.  surgical instruments,  crates, carts, etc.) Mobiles  assets  Patients,  staff, mobile  assets Sensitive  products (e.g.  vaccines) Units identification Units data capture Communication Networks  E.g., Wired and wireless LAN (Wi Fi, 802.1x access points) Back end Hospital Information Systems (HIS) ERP CMS E.g., Enterprise Resource Planning system (ERP); Clinical management system RFID Middleware platform Stand alone platform or EIS modular option (e.g., sensor-driven / real-time event processing engine) Antennas and location  identifiers (tag sensors,  exciters)
  • 4. hospital systems (i.e., Enterprise Resource Planning systems-ERP, Clinical Management System-CMS), where this information is managed to improve the decision making process. 4 Research Methodology: Using a Case Study Approach RFID-enabled projects in the healthcare context is an emerging phenomenon in complex environments [17], which involve numerous stakeholders, with references to change management as well as ethical and legal considerations [13]. Therefore, the case study approach was selected as the preferred research strategy to facilitate the identification of the main concepts involved and to investigate the problem “within its real-life context” [21]. The case study was conducted at a hospital, where the underway construction of a new building will be the new home for the CSD and OR departments. This relocation brought up the opportunity of improving the flow of items (e.g., surgical instruments) from CSD to OR. Using case carts for transferring items as well as implementing a traceability system were considered. The business process re-engineering (BPR) approach was adopted to identify the impact of RFID technology on selected surgical equipment tracking and tracing processes (see Fig. 2). BPR is an approach that focuses on value- added business processes [6] and how an organization should operate to better meet the needs of its customers. This approach involves discovering how business processes currently operate, how to redesign these processes to improve the efficiency, and how to implement the process changes to gain competitiveness [5]. As presented in Fig. 2, this research followed four steps which are elaborated in the following sections. Within this paper we focus on steps 1 and 2, namely understanding specifications of the current process and modeling them, whereas the main objective is to redesign the process to include the traceability system as well as the case cart practice.   Steps 1 and 2: Understanding current business process and modeling As-Is process: In order to map and analyze the current process, the flow between CSD and OR was studied in detail. Information in regards to the stakeholders of the process, as well as the activities, inputs, outputs, control points, and the information flow within the IT system of the hospital was gathered. The main sources of data collecting were (i) on-site observations, (ii) open ended interviews with project managers, head manager of the CSD and OR, employees from CSD, and managers responsible for material management and purchasing, and (iii) complementary documents such as internal business analyses. The “As-Is” process flow between CSD and OR in the actual building was then mapped, analyzed, and served as a basis for the “To-Be” analysis. This exercise supported proposing scenarios (in step 3) by recognizing the changes that come with relocating these departments to the new building, as well as the requirements for including the traceability system (e.g., IT system and interfaces). Since the emphasis of this research was on
  • 5. processes related to the traceability of medical items and the case cart incorporation, new steps in the process were considered. Step 3: Performing a To-Be analysis: A first scenario of a process flow was proposed and mapped between CSD and OR in the new building. In this case, the existing barcoding system is used for tracking and tracing of crates and instrument sets throughout the process. This initial mapping is discussed in section 5 as it constitutes the basis of comparison with alternative options including RFID enabled traceability. In order to evaluate the performance of designed processes, different control points were identified and process owners were asked to identify relative key performance indicators (KPIs). As further research to this paper, each scenario will be modeled, measured and analyzed by using Arena as a discrete event simulation software. Fig. 2. BPR approach for this research Step 4: Implementing and measuring: The “what if” analysis results of the simulations will lead to decisions regarding the selection of processes with the highest performance. Additionally, a trade off analysis will need to be performed to weight decisions by taking into account factors such as (a) the marginal contribution on the process performance of Perform What‐if Analysis Measure, simulate and analyze  (prospective) alternatives Model the future processes TO‐BE Analysis FEEDBACK Model the current  processes (traceability of  equipment) AS‐IS Analysis Select one scenario, manage  transition (pilot project )  and monitor performance Implementation &  measurement  ‐ Objectives ‐ Stakeholders ‐ Inputs/outputs ‐ Control ‐ Information systems ‐ Performance monitoring  frameworks ‐ KPIs ‐ Stakeholders/Roles ‐ Information systems Understand the current  hospital’s business  processes ‐ Simulation Tools (Arena) ‐ Business process tools (Visio; Aris/Software AG) Data gathering Using different options ‐ Manual data capture ‐ 1D and 2D bar codes (item level) ‐ RFID technologies (item level) ‐ Hybrid options (RFID + bar code)
  • 6. each technological scenario, (b) the total cost of ownership (investment costs, identification/tagging costs, operations cots), and (c) the probability of technical success. Therefore, the technical feasibility of the proposed solutions will need to be validated and the business process robustness be tested. For this purpose, a prototype of an RFID enabled traceability system will be (i) built and tested in a RFID lab, and then (ii) implemented onsite as a pilot project. The selected scenarios/process flows will constitute the guideline for tagging and tracking of designated assets (crates, instruments). Finally, its performance will be compared with the alternative processes (e.g., using barcodes). 5 Analysis: Redesigning Traceability Process at the Hospital 5.1 A Scenario of Traceability Process Since hospital managers are mainly interested in leveraging on actual barcoding systems, a scenario was proposed and designed, based on the original “As-Is” tracking and tracing process of instrument sets and crates between CSD and OR. In this scenario, existing uni- dimensional 1D barcodes are used for the traceability at the case cart level (used for transporting instruments) throughout the process and two-dimensional (2D) data matrix barcodes are used for the preparation of instruments sets (see barcoding system in Fig. 3 and redesigned process in Fig. 4). A further “What-If RFID technology was used” analysis will be performed for a better understanding of the marginal contribution of using this technology over the existing one. Fig. 3 Barcode system used for tracking crates and instrument sets
  • 7. Fig. 4 presents the macro processes related to case cart preparation by CSD, the picking process at sterile core and how the instruments are treated inside the operating theatres, the reprocessing of soiled instruments, as well as replenishment activities for CSD and sterile core storage. For an increased granularity, each main process was also decomposed into specific sub processes and activities (not presented in this paper). In order to identify all the locations and stakeholders involved in the process, the layout of new CSD department was separated in different zones: soiled case cart zone, soiled zone (decontamination zone), clean zone (assembly zone), sterile zone, and storage zone (carousel and shelving). Similarly, the OR was divided into three sections: OR general management, operating theatres, and sterile core. Additionally, all the scanning points (and related update of information in the hospitals ERP system) have been specified. The tracking and tracing of instrument sets/trays is done (i) during picking in the CSD storage zone, (ii) inside the operating theatre and before using the instruments in the surgery, and (iii) during the reprocessing of soiled instruments and re-assembling the instrument sets. The process starts once a CSD employee receives a preparation list based on the surgeries planned for the next day. He picks the items from storage and send the case carts to sterile core where an OR attendant will complete the case cart -and so on. Using 1D barcodes to identify and track crates and 2D data matrix barcodes to identify the list of instrument sets throughout this process was identified by key respondents as a way of (i) reducing errors in assembling the instrument sets, (ii) linking patients with instrument sets used in specific surgeries, (iii) locating instrument sets at each point of time, and (vi) keeping records of cleaning and disinfection cycles. Although this visibility at the crate level is interesting, it does not provides a full accountability for every surgical instrument and every step of the process. This is why other scenarios were envisioned, firstly by considering a different level of tagging (barcodes at the crate and instrument level) and then by considering different technologies (RFID, hybrid RFID/barcode solutions). For instance, in one scenario, the engraved numbers of 2D barcodes (permanent marking using micro-percussion or KeyDots- labels applied directly to an instrument’s surface), could be used similar to a license plate for tracking individual surgical instruments beyond the crate/tray level. While these solutions are highly reliable, reading each individual instrument (which requires to correctly align the laser) takes few seconds per item, leading to limited productivity gains. Since each tray contains an important amount of instruments, each time that the instruments need to be scanned this leads to a time consuming non value added activity. Therefore, respondents suggested to identify and match individual surgical instruments with the crate during the preparation of the set at the CSD and use barcodes at the crate level for the following processes.
  • 8. Fig. 4 Process mapping of redesigned process – scenario 1 Traceability Throughout the Case Cart Preparation Process – High Level Mapping OR‐ Sterile Core OR‐General  Management CSD‐Soiled Case  Cart Zone CSD‐Clean ZoneCSD‐Sterile ZoneCSD‐Storage Zone Material Management  and Purchasing OR‐ Operating Theatre CSD‐Soiled Zone Legend  Determine  the surgery  list for next  day Get a case  cart Pick items  from carousel  and shelves Transport case cart  to OR‐sterile core  via clean elevators Take the cart inside  operating theatre Surgery  starts Pick rest of  items from  Sterile Core Surgery  ends Nurse put Soiled items  In case cart and leave it  in Soiled Holding Zone OR attendant transport  case cart to CSD via  soiled elevator Empty the  case cart Wash the soiled  case card in  washing machines Decontaminate  and wash the  intruments Park the  soiled  case cart Case carts  are ready  to be used Assemble the  instrument  sets Sterilize  instrument  sets Restock  carousel  and shelves Instruments  are ready to  be used Opera  Carousel  System Order based on  the purchasing  demands Receive  ordered  items Record and  de‐box  items Restock  carousel  and shelves Items  ready to  be used ERP  system:  Logibec  Restock the  sterile core  storage Items are  ready to be  used Park the case  cart near the  operating  theatre Items should  be stored in  CSD? Transport  items to CSD Transport items to  sterile core NO Preparing  case cart Operating  Theatre and  Sterile Core Reprocessing  of soiled  instrum ents M aterial  M anagem ent Once a surgery list  is planned, A  preparation list  request Is  transferred to CSD  (about) 24hrs in  advance; at 9pm of  the day before  surgery by the  latest The preparation of  case carts starts  during the night shift  (10pm‐6am). When  the night shift  employees arrive,  the CSD supervisor  provides the printed  preparation list. OROR CSDCSD MMMM A,B Responsible from OR (nurse,  team leader…) Sterilization department  employee Responsible from material mgt  (store keeper, employee…) Purchasing demand CSD: Central Sterilization Department OR: Operating Room ORMS: OR Management System Flow of information In ERP  Beginning/end of a process Employee/system interaction Transport of items or case cart Operation  Decision  Links between high level processes  and detailed level processes Links between different sections  of detailed level processes Print & attach  preparation  list to each  case cart Scan the cart/s  (barcode on the  preparation list) Instrumental  Scan the case  cart and  instrument sets Opera/ Instrumental Scan the  instrument trays  and the case cart Instrumental  Scan the tray for  opening the  assembly recipe  Instrumental  Generate  production label &  attach to the set Scan the production  label (recording which  sterilization machine) Instrumental  Record  itemsCSDCSD CSDCSD CSDCSD OROR OROR OROR OROR OROR MMMM CSDCSD CSDCSD CSDCSD CSDCSD CSDCSD CSDCSD MMMMMMMM Yes
  • 9. 5.2 “What- If” RFID Technology Was Used? A “What- If” analysis has started to explore the marginal contribution of using RFID technology over the existing system. One envisioned impact of using RFID is to increase the automation of internal logistic processes for the tracking of equipment while progressing through all stages of the processes. With RFID enabled bulk-reading of tagged instruments, a whole tray/crate can be automatically loaded into the CMS, eliminating non value added activities at (a) preoperative stage (e.g., preparation of the crates and related time spent at CSD storage zone for scanning items), (b) intraoperative stage (e.g., verification of crates before surgical interventions and related time spent at the OR sterile core and inside the operating theatre) (c) postoperative stage after usage by the OR (i.e., tracking instruments through the sterilization process and ensure the compliance with sanitary regulations). Additionally, enabling identification at the instrument level prevent the loss of instruments who might be left aside during one operation. In the past years, some RFID suppliers started to propose surgical instruments traceability solutions that leverage on RFID technology (e.g., Xerafy and Caretag, Haldor Advanced Technologies). For instance, Xerafy developed a series of highly resistant (IP68), autoclavable, FDA compliant, small UHF RFID ceramic tags that can be mounted on individual metal surgical instruments (i.e., Dash-On XS; Dot-On XS tags; Dash-iN XS; Dot-iN XS for instruments or MicroX II-Autoclavable Version and Roswell tags for surgical Trays). Thanks to the standards regulating passive RFID UHF technologies, these tags can be read with any RFID equipment from different vendors in the industry such as Zebra/Motorola, Alien technology or impinj. For the Middleware solution, vendors like Caretag have developed specialized modular traceability solutions for the management of surgical equipment. Additionally, actual players in hospitals are leveraging on their own solutions to enable RFID integration. While the business logic is the same, the data capture is radically different with RFID. Conversely, while using RFID for the tracking of instruments is interesting in terms of process efficiency, embedding or attaching RFID tags on instruments requires specific competencies and equipment (e.g., covering the tag with FDA-approved USP Class VI epoxy resin to secure the tag in place and ensuring the right tag placement to maximize performance). While this step can be outsourced to specialists, it was identified as an issue in the project, considering (a) the important amount of individual equipment to be tagged, (b) the time required to identify and match each item in the data base, and (c) the upfront investment costs for RFID hardware infrastructure, middleware platform configuration and integration, project management, etc. There is no doubts that potential benefits need to be properly evaluated for accurately measuring operations savings and building a business case.
  • 10. 6 Conclusion and Further Research This paper raised the importance of using simulation software such as Arena as a “process analyzer” to efficiently compare the “What-If” envisioned scenarios. As further steps to this research, modeling of different scenarios for the designed process will need to be done. Additionally, in order to measure the performance of the traceability process, control points and relative KPIs need to be identified by process owners as well as by looking at existing logistic performance frameworks [16]. In this research some KPIs are already specified and will constitute the basis for further analysis. The first KPI is obviously related to the productivity of the process and its “responsiveness”, by analyzing the activities related to the “fulfillment cycle time”, in particular by measuring the “average time for case cart preparation”, i.e., the time spent to prepare the case cart at CSD and sterile core. In fact, the time factor will be measured elsewhere in the process wherever there is a time consuming activity that can be reduced or eliminated with RFID technology – such as “average time for” counting/ verifying/ validating/ etc. The second KPI is related to the “reliability” of the process by analyzing the order fulfillment performance, in particular with measuring the “accuracy of case cart preparation”, i.e., the % crates that are delivered according to demands from OR (item accuracy and quantity accuracy). This is of a particular importance since any discrepancy between the preparation list and the instruments delivered will have an impact on the productivity of the process and will involve re-processing the orders. Of course, the situation might be worst if the discrepancy is not detected before surgery where instruments are need immediately. Other KPIs may also be of interest for other departments such as material management and purchasing in charge of renewing instruments, as well as the CSD storage (on carousel and shelving). For instance, the status of each instrument (in its life cycle) and the “inventory availability” may be measured for ensuring high quality in service delivery without creating excess inventory of instruments. Since the main objective of this research was to explore the realistic potential of RFID for improving the traceability of medical equipment, the next steps will be (i) proposing a redesigned flows that facilitates the traceability processes of case carts and/or individual instruments between CSD and ORs, (ii) identifying the “best case” scenarios, and (iii) realistically assessing the potential of RFID technologies for improving this process. References 1. Barge P., Gay P., Merlino V., Tortia C.: Item-level Radio-Frequency id. for the traceability of food products: Application on a dairy product. J. of Food Eng. 125, 119-130 (2014). 2. Bendavid Y., Boeck H., Philippe R.: RFID-Enabled Traceability System for Consignment and High Value Products: A Case Study in the Healthcare. J. Med. Sys. 36(6), 3473-3489 (2012).
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