Table of Contents

GS1 Standards in healthcare: raising the bar on patient safety and supply chain efficiency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

U.S.A.: Change has finally come: U.S. Healthcare industry to implement common data standards
to improve safety, reduce costs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

P. R. China: Shanghai Food and Drug Administration – Implementation of a post-market traceability program
for implantable medical devices adopting unique device identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Australia: Building traceability in Australian healthcare. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

France: Unique Device Identification of surgical instruments by DataMatrix 2D barcodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

U.K.: The NHS Procurement eEnablement Programme – Using information to deliver better healthcare. . . . . . . . . . . . . . . . . . . . . 22

U.K.: Integrating information flows in orthopaedics at Leeds Teaching Hospitals NHS Trust. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Japan: rfid and barcode based management of surgical instruments in a theatre sterile supply unit. . . . . . . . . . . . . . . . . . . . . . . 32

U.S.A.: BPOC/eMAR spotlight on performance improvement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Australia: eCommerce within the hospital pharmaceutical supply chain lays foundation for improved patient safety. . . . . . . . 40

Switzerland: SmartLog: a Swiss drug traceability pilot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Canada: Transforming the Canadian healthcare supply chain: creating the future roadmap for success. . . . . . . . . . . . . . . . . . . . . . 48

Germany: Return on investment of standardised bar coding at Herz-Zentrum Bad Krozingen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Spain: Efficiency models in the Andalusian Health Service supply chain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Welcome to the first edition of the GS1 Healthcare Reference Book (Edition 2009/2010), a
compendium of information on global standards in the Healthcare supply chain, adoption initiatives,
lessons learnt from implementation projects, regulatory developments and more. Experts from
different countries and different backgrounds share their perspectives on, and experiences with,
supply chain projects, patient safety initiatives and regulations. We hope that you gain valuable
information from this publication and we extend our appreciation to all the contributors that have
made this possible.

Acknowledgements
GS1 Healthcare would like to thank the following for contributing to this GS1 Healthcare Reference Book:
• Nigel Allsop (Health Purchasing Victoria, Australia)
• Alexandra Fabreguettes (Robert Ballanger Hospital, Aulnay, France)
• Frédérique Frémont (Robert Ballanger Hospital, Aulnay, France)
• Jesus Gavira (SAS Andalusian Health Service, Spain)
• Ged Halstead (CH2, Australia)
• Yasmine Hassani (Robert Ballanger Hospital, Aulnay, France)
• Noel Hodges (HCA Central Atlantic Supply Chain, U.S.A.)
• Rachel Hodson-Gibbons (NHS Purchasing and Supply Agency, U.K.)
• Anthony Keyes (Baxter Healthcare, Australia & New Zealand)
• Holger Klein (Herz-Zentrum Bad Krozingen, Germany)
• Ian Larmour (Southern Health group of hospitals in Melbourne, Australia)
• Herb Martin (CareNET, Canada)
• Laurent Médioni (Fribourg Canton Pharmacy, Switzerland)
• Graham Medwell (Leeds Teaching Hospitals NHS Trust, U.K.)
• Jeanne Mignon (Robert Ballanger Hospital, Aulnay, France)
• Georges Nicolaos (Robert Ballanger Hospital, Aulnay, France)
• Dr. Chikayuki Ochiai (Kanto Medical Center NTT, Tokyo, Japan)
• Joe Pleasant (Premier, Inc., U.S.A.)
• Marine Tournoud (Robert Ballanger Hospital, Aulnay, France)
• Liang Yan (Shanghai Food and Drug Administration, China)

In addition, we would like to thank the following GS1 Member Organisations for facilitating this process:
• GS1 Australia (contact: Tania Snioch - [email protected])
• GS1 Canada (contact: Alicia Duval - [email protected])
• GS1 China (contact: Zexia Huang - [email protected])
• GS1 France (contact : Valérie Marchand - [email protected])
• GS1 Germany (contact: Bettina Bartz - [email protected])
• GS1 Japan (contacts : Michio Hamano - [email protected] and Yasuo Kurosawa - [email protected])
• GS1 Spain (contact: Mónica Soler - [email protected])
• GS1 Switzerland (contact: Christian Hay - [email protected])
• GS1 UK (contact: Roger Lamb - [email protected])
• GS1 US (contacts: Dennis Harrison – [email protected] and Annette Pomponio - [email protected])

2009/2010 GS1 Healthcare Reference Book 1

GS1 Standards in healthcare:
raising the bar on patient safety and
supply chain efficiency

Abstract

Patient safety, supply chain security, traceability and efficiency in

Healthcare are currently at the forefront of government regulatory and
industry concerns around the world. As a result, numerous, and often
Article by Ulrike Kreysa
incompatible solutions are being (or have been) proposed to the national
and Jan Denecker
and international supply chain stakeholders and, in some cases, adopted
in preference to global standards. The cost of diverse government
regulations, proprietary services and incompatible solutions being offered
to stakeholders has made it clear that there is a need to define and increase
adoption of open, global standards. This is the mission of GS1 Healthcare.

Challenges and opportunities in the multi-echelon global supply chains that currently lack
healthcare supply chain transparency, making it vulnerable to infiltration by
Patient safety initiatives across the world tackle the counterfeiters. The introduction of a unique identification
challenges in the Healthcare supply chain, including for each and every pack, where appropriate, will enable
the reduction of medication errors, the fight against traceability and authentication systems with readily available
counterfeiting, optimised post-market surveillance, etc. technology. This will make it much more difficult for
counterfeiters to intrude into the Healthcare supply chain, or
More than 30% of all adverse drug events are preventable at least, make it uneconomic.
and appear to be consequences of medication errors1.
Adverse events from medication errors represent a significant Other patient safety initiatives are related to improving post-
problem for Healthcare worldwide, as indicated by several market surveillance and adverse event reporting, product
studies in different countries. An Adverse Event Study in recalls, disaster preparation, treatment documentation, etc.
one country indicated that 9.3% of hospital stays incurred
a serious adverse event, with medication errors being the Reducing costs and increasing supply chain efficiency
main cause (37.4% of such events)2. The implementation of will contribute to keeping soaring Healthcare costs under
automatic identification systems, up to the point-of-care, has control. Diverging country requirements for supply chain
proven to significantly reduce medication errors; for example, data further complicate an already complex production,
the Veterans Affairs Medical Center in Topeka, U.S.A., has packaging and distribution system and add risk and cost.
reported that bar coding reduced its medication error rate by Manual systems and processes in hospitals are unable
86% over a nine-year period3. to efficiently and safely handle the constant change that
occurs with supplies and pharmaceuticals. Standardised
Counterfeit Healthcare products are in the first place a automatic identification and traceability systems will
risk to public health. It is almost impossible for patients simplify and improve accuracy in a number of supply chain
and dispensing Healthcare professionals to spot the processes from production to point-of-care or point-of-sale.
fakes. Healthcare products are supplied through complex,

2 2009/2010 GS1 Healthcare Reference Book

 GS1 Standards in healthcare: raising the bar on patient safety
and supply chain efficiency

Welcome to the world of GS1 Standards

Open, technology-independent standards permit full
interoperability and compatibility. End users are not locked
into proprietary solutions and R&D resources can be freed
up for other added value developments once standards
have been adopted.

GS1 Standards are not only open and technology-

independent, but also truly global, which is vital in supply
chains that often cross borders.

First of all, the GS1 System of Standards incorporates a set of

Identification Keys. These are numbers identifying products
and services and providing access to information held in
computer files. These numbers are:

• Unique: every variant of an item is allocated a separate

unique number; GS1 eCom (Electronic Data Interchange) provides global
• Non-significant: they identify an item but contain no standards for electronic business messaging that allow rapid,
information about it; efficient and accurate automatic electronic transmission of
• International: GS1 Identification Keys are unique across agreed business data between trading partners.
all countries and all sectors;
• Secure: GS1 Identification Keys are fixed length, numeric GS1 Traceability Standards provide a powerful tool kit for
and include a standard check digit implementing traceability to enable full actionable visibility
of pharmaceuticals and medical devices from point-of-
At the heart of the GS1 System is the GTIN (Global Trade production to point-of-sale or point-of-care, to ensure
Item Number) Identification Key. These numbers are maximum interoperability between traceability systems
allocated by the manufacturer, according to the GTIN across the Healthcare supply chain and across borders.
Allocation Rules and include; a GS1 company prefix assigned
to a company by GS1, an item reference assigned by the
GS1 Fast Facts:
company and an automatically generated check digit. GS1
• User-driven standards organisation
has published specific Healthcare GTIN Allocation Rules, due
• Member organisations in 108 countries
to the complex needs of the industry.
• 2,000 employees supporting 1.2 million companies
• 6 billion ‘beeps’ per day, based on GS1 Standards,
The GS1 System also incorporates a number of other
make it the most widely used system of supply
Identification Keys, including GLN (Global Location Number),
chain standards
SSCC (Serial Shipping Container Code) and GRAI (Global
Returnable Asset Identifier).

GS1 Identification Keys can then be carried on any type of A voluntary, global Healthcare user group
data carrier, a GS1 bar code (linear or 2-dimensional) or an GS1 Healthcare is a voluntary, global Healthcare user group
EPCglobal Radio Frequency Identification (RFID) tag, on the bringing together all related Healthcare stakeholders.
specific product or packaging. Members range from leading pharmaceutical and medical
device manufacturers, healthcare providers, distributors and
The GS1 Global Data Synchronisation Network (GDSN), built Group Purchasing Organisations (GPOs), governmental and
around the Global Registry and GDSN-certified data pools, regulatory bodies and associations including the U.S. FDA,
provides a powerful environment for secure and continuous Public Health Agency Canada and Eucomed.
synchronisation of accurate product and location data.

2009/2010 GS1 Healthcare Reference Book 3

GS1 Standards in healthcare: raising the bar on patient safety
and supply chain efficiency

The mission of GS1 Healthcare is to bring together experts Some notable examples are:
in Healthcare to develop and implement global standards
to successfully enhance patient safety and supply chain In the U.S.A.
efficiencies. • AHRMM, a professional membership group of the
American Hospital Association serving more than 4,000
GS1 Healthcare is now widely recognised as an open and active members
neutral source for regulatory agencies, trade organisations • Amerinet, a GPO serving more than 2,200 acute care and
and other similar stakeholders who are seeking input and 25,000 alternate care health systems members
direction for global standards in Healthcare for patient • Novation, a GPO serving 2,500 members of VHA Inc.
safety, supply chain security and efficiency, traceability and and the University HealthSystem Consortium (UHC) and
accurate data synchronisation. nearly 12,000 members of Provista, LLC
• Premier Inc., a GPO serving more than 2,000 hospitals
Healthcare suppliers advance global and 53,000-plus other healthcare sites
supply chain standards • SMI (Strategic Marketplace Initiative): 32 healthcare
Confronted with diverging country specific product provider members, including for example Duke
identification requirements and developing traceability University Health System, Johns Hopkins Health System,
requirements, suppliers were instrumental in establishing Mayo Clinic, Sisters of Mercy ~ ROi, SSM Health Care,
the global Healthcare user group in 2004-2005. Many University Kentucky HealthCare, and Yale New Haven
leading suppliers are members of the global Healthcare user Health System
group and actively drive global standards development and In Austria
adoption at a global level. • Orthopädisches Spital Speising GmbH, Vienna (Vinzenz
Gruppe) and Wiener Krankenanstaltenverbund are
At a global level, current supplier members include (dd. members of the global Healthcare user group
April 2009); Abbott, Alcon, Amgen, Baxter, B. Braun, Boston In Canada
Scientific, Bristol-Myers Squibb, Cook, Covidien, Edwards • CareNET, a not-for-profit organisation comprised of over
Lifesciences, Fresenius Kabi AG, GlaxoSmithKline, Johnson 450 hospitals across Canada
& Johnson, King Pharmaceutical, Medtronic, Merck & Co., • HealthPro, a GPO serving 485 hospitals
Novartis Pharma, Pall Medical, Pfizer, Purdue Pharma, Sakura • MedBuy, a GPO serving more than 350 Healthcare
Seiki, Schering-Plough, and Smiths Medical. facilities
In Chile
At a national level, many more suppliers are member of • Cenabast, the Supply Center for the Ministry of Health in
a GS1 Member Organisation and are involved in national Chile
initiatives to drive adoption and implementation of GS1 In France
Standards in the Healthcare supply chain. • UNIHA, a network of 32 university hospitals and 22 large
hospitals
Also other stakeholders, such as distributors, retailers, and In Germany
logistics providers have been involved. Global members • Comparatio Health, a GPO comprised of 6 university
include; CVS, Cardinal Health, DHL Exel Supply Chain, and hospitals
McKesson. • EK UNICO, a GPO comprised of 13 university hospitals,
including 300 special clinics and more than 240
Healthcare providers advance global institutes
supply chain standards In Hong Kong
Leading Healthcare providers and Group Purchasing • Hong Kong Hospital Authority, a statutory body
Organisations (GPOs) worldwide are endorsing GS1 managing 40 public hospitals, 48 specialist clinics and 75
Standards and are paving the way for sector-wide adoption. general clinics
In Japan
• Tokyo Medical University, Kanto Medical Center and
Nagoya University Hospital, etc.

4 2009/2010 GS1 Healthcare Reference Book

 GS1 Standards in healthcare: raising the bar on patient safety
and supply chain efficiency

In the Netherlands • Providing input to the Global Harmonisation Task Force

• NFU (the Dutch Federation of University Medical Centre), (GHTF), U.S. FDA, the European Commission, and others,
comprised of 8 university medical centres on the adoption of GS1 Standards for Unique Device
• Erasmus MC Hospital Rotterdam and Universitair Identification (UDI)
Medisch Centrum Groningen are members of the global • Providing input to the Italian Ministry of Health who is
Healthcare user group currently reviewing the ‘Bollino’ system
In Switzerland • Providing input to the Turkish Ministry of Health to
• Geneva University Hospitals are members of the global ensure full compliance with GS1 Standards
Healthcare user group • Providing input to the WHO Technology work group of
In the U.K. IMPACT (Anti-Counterfeiting Taskforce)
• The Department of Health best practice guidance • Provided input to the Japanese Ministry of Health,
Coding for Success recommended that both industry Labour and Welfare, resulting in revised bar code
and the NHS adopt the GS1 System of coding standards. guidelines for medical devices in line with GS1 Standards
Over 175 NHS hospitals have registered for GS1 UK • Provided input to the UK Department of Health resulting
membership. in the ‘Coding for Success’ programme
• Provided input to the Public Health Agency of Canada
GS1 Healthcare advocates global resulting in the GS1 Standards-based vaccine bar coding
harmonisation project
Global standards will enable all stakeholders to efficiently • Provided input to the EFPIA project for coding and
and effectively comply with various identification, identification of pharmaceutical products
traceability and product catalogue requirements. To this • Provided input to the Australian National eHealth
end, GS1 Healthcare user groups (local and global) aim to Transition Authorities (NeHTA) resulting in endorsement
be a neutral and trusted source for governmental bodies, of GS1 Standards
regulators and associations for all related matters. Some • Provided input to the California Board of Pharmacy for
notable examples are: ePedigree requirements to comply with GS1 Standards

• Providing input to the European Commission for the GS1 Healthcare will continue to promote global supply
legislative proposals to ensure safe, innovative, and chain standards and invites all stakeholders to join the user
accessible medicines currently being developed group, either at national or global level.

For more information about GS1 Healthcare, visit

www.gs1.org/healthcare

References

1 “Creation of a better medication safety culture in Europe: Building up safe medication practices” – Expert Group on Safe Medication Practices,
Council of Europe – 2007
2 Estudio Nacional sobre los efectos adversos ligados a la hospitalización (ENEAS 2005). Informe. Febrero 2006. Ministerio de Sanidad y
Consumo. Madrid 2006
3 “Strategies to Reduce Medication Errors - How the FDA is working to improve medication safety and what you can do to help”,
Michelle Meadows, FDA Consumer magazine May-June 2003

Authors

Ulrike Kreysa is Director Healthcare, GS1 Global Office Jan Denecker is Marketing Manager Healthcare & GDSN,
([email protected]) GS1 Global Office ([email protected])

2009/2010 GS1 Healthcare Reference Book 5

U.S.A.

Change has finally come:

U.S. Healthcare industry to implement common
data standards to improve safety, reduce costs

Abstract

Product information in the U.S. healthcare supply chain is inconsistent and

inaccurate. Currently, the industry suffers from the lack of a systematic
way to consistently identify distinct medical/surgical products, which
Article by Joe Pleasant,
negatively impacts the rest of the supply chain, including the quality of
CIO and Senior VP,
care delivery for patients. With e-commerce now defining the day-to-day
Premier, Inc.
business processes in the healthcare setting, the healthcare industry must
leverage technology advances to create a more efficient and effective
supply chain, to reduce unnecessary costs and to improve patient safety.

After decades of studies, pilots and colorful debate, the Healthcare’s most basic data – electronic descriptions of
healthcare industry is finally making huge strides toward the the products used to treat patients, which companies
selection and implementation of a consistent set of supply manufacture these products and where the products should
chain data standards and a system to synchronize product be delivered – is unreliable, inconsistent and out of date. Bad
information so that all trading partners can speak the same data has long served as the source of a negative ripple effect
electronic language. These standards, by GS1, have been throughout the supply chain that adds billions of dollars
proven successful in other multi-billion dollar industries. in avoidable costs, creates inefficient processes and, most
They are being endorsed by healthcare’s leading provider importantly, negatively impacts patient safety.
organizations, including the Premier healthcare alliance, as a
means to ensure basic information in the healthcare supply Other multibillion dollar industries, including grocery,
chain is accurate, up to date and synchronized. Premier and hardware and retail, run their supply chains more effectively.
others have taken steps to accelerate the implementation of What is their secret? These industries identify products
the GS1 standards in order to bring about greater efficiencies, using consistent electronic data standards, synchronized
reduce costs and improve the quality of patient care. through a single source of accurate product information, to
bring data truth to every part of the supply chain.
Healthcare’s Dirty Data
In 2008, healthcare spending in the United States reached Unlike virtually every other product in commerce, medical
$2.4 trillion, representing a staggering 17 percent of the supplies and devices cannot be identified in a systematic
nation’s gross domestic product. Medical supplies – a and consistent manner, and the healthcare industry is not
$200 billion industry – typically account for up to 40% of a able to reliably identify potentially life-threatening recalled
hospital’s operating costs, and represent the second largest or defective medical devices. Whereas other industries
expense to hospitals after labor. Industry estimates point to use consistent and synchronized data standards to ensure
more than $11 billion of waste each year due to inefficient all trading partners and information systems speak the
processes, rework, order and invoice errors and outdated same electronic language, healthcare lags in the ability,
information technology. At the core of these problems is for example, to track and trace a recalled product from
bad supply chain data. manufacturer to end use, or the patient’s bed side. 

6 2009/2010 GS1 Healthcare Reference Book

 Change has finally come: U.S. Healthcare industry
to implement common data standards to improve safety, reduce costs

Recalled pet food contaminated with deadly chemicals can

be quickly and efficiently removed from shelves, but we
cannot reliably identify potentially life-threatening recalled
or defective medical devices. Most experts also agree that
one of the primary reasons for increased supply costs and
the inefficiency of the healthcare supply chain is the lack
of consistent Unique Device Identification (UDI), accessed
through a synchronized Product Data Utility (PDU) – a single
data source in healthcare that all constituents access for the
most up-to-date product information available.

The absence of a UDI via a PDU also results in dirty or

inaccurate product item masters that create mismatches
in accounts payable; wasted clinician time searching for
correct products; and inaccurate pricing, rebates, returns
and credits. The data language problem exacerbates the
broken supply chain, creating confusion and manual rework
as the norm, with the impact being adverse affects on
patient safety and increased costs.

In addition, efforts to implement Electronic Health Records

(EHR), Radio Frequency Identification (RFID) and other high- universal and global set of data standards and a system to
visibility patient safety technologies are important but will synchronize critical product data.  Even the U.S. Congress has
fall short if the data foundation is not in place in the nation’s mandated the use of a single UDI system, similar to what we
medical supply chain. In a society where scanning the see in pharmaceuticals and in every other industry, with the
barcode of a pack of gum is done in an instant and without passage of legislation in fall of 2007. 
a second thought, it is hard to fathom just why healthcare is
so behind given the life-saving nature of its products.  The industry is voicing its support of three standards
from GS1 based on their success in other industries, as
The New Gold Standard well as other criteria such as their global applicability (see
in the Healthcare Supply Chain information box). Lessons from ongoing industry pilots,
In 2006, the Premier including the U.S. Department of Defense test of the Global
healthcare alliance, Data Synchronization Network® (GDSN®), proves that such
an alliance of more a system could serve as a platform for healthcare data
than 2,100 not-for- synchronization, validates that data synchronization is
profit hospitals working to improve the quality and cost achievable in the near term, on a large scale, with immediate
of healthcare, surveyed its members to better understand value realized.
how the industry tracks and records medical device recalls.
The survey showed that the recall “process” was more like a Many provider organizations have taken an additional step
“guessing game”, and 80% of respondents said they believed by requiring their manufacturer partners to incorporate
that an industry-wide UDI for medical devices would certain standards in order to win contracts. Premier
enhance patient safety. announced in July of 2008 that suppliers who win their
national contracts must adopt GS1 standards within five
Industry leaders are rallying to take a long-overdue stand years, and the industry endorsed implementation dates
against the dangerous status quo in the healthcare sup- for GLN (2010) and GTIN® (2012). The decision was made
ply chain. In the past year, several influential organizations, to issue the requirement based on years of input from
including providers, group purchasers and industry asso- member hospitals and participation in industry standards
ciations, called for industry implementation of a common, efforts. Our belief is that the timing of the requirement will

2009/2010 GS1 Healthcare Reference Book 7

Change has finally come: U.S. Healthcare industry
to implement common data standards to improve safety, reduce costs

accelerate implementation of the standards that are needed patient may have used.  These standards will contribute to
to improve patient safety, reduce costs and drive efficiency interoperability in healthcare, and will streamline the flow of
(see timeline and roadmap graphics). Due to our purchasing information in the supply chain and beyond.
power, organizations like Premier can play a significant
role in the acceleration of standards implementation, a With these standards serving as a basic foundation,
responsibility that we take seriously. hospitals and suppliers will be better able to automate
the data capture process via RFID and bar coding.  The
It is anticipated that the U.S. Food and Drug Administration current challenges inherent in healthcare’s e-commerce
will issue its requirement to manufacturers to use a uniform transactions – varying levels of system sophistication,
system that recognizes the GS1 standards, a system that outdated IT, manual data inputting, inaccurate information
has proven itself in other industries and around the world. – will be a distant memory, making room for more effective
In addition, healthcare manufacturers are already using GS1 methods and providing a baseline for electronic records
standards to support their other markets here and abroad. management.  With everyone in the supply chain “speaking
the same electronic language,” products can be better
This initiative, which will impact hundreds of thousands tracked and traced throughout, improving healthcare’s
of medical devices and supplies, complements and chaotic recall process and reducing the potential for the
strengthens the FDA’s work to create a uniform and introduction of counterfeits.  Increasing efficiency will
nationwide system and will accelerate adoption by the reduce costs and positively impact patient safety – the
industry as a whole. Collaborating with suppliers on mission shared by all constituents of undeniably the nation’s
standards adoption will help ensure correct products are most important supply chain. 
delivered to correct locations, leading to an increase in
patient safety, and a decrease in supply chain costs. The U.S. healthcare industry is pursuing the extraordinary
opportunity to leverage technology advances to create
The GS1 standards – the GTIN, GLN and GDSN® – are used a more efficient supply chain, reduce costs and, most
by Wal-Mart and other large retailers, and support the importantly, to improve the safety of patients that use
supply chains of the hardware, electrical and consumer medical products as part of their care. The question has
goods industries among others.  They are tried and true in evolved from “if” to “when” the industry will reap the benefits
those industries, with results showing that clear visibility of adopting and implementing consistent supply chain data
to product information by both suppliers and buyers leads standards, and that time has come.
to more efficient business processes, reduced costs and
increased revenues.  Everyone has something to gain. The GS1 standards required
Studies in healthcare show the same promising results, with in Premier contracts include:
the added benefit of increased patient safety. • Global Trade Item Number® (GTIN®) – A GS1 standard used
to uniquely identify products at all packaging levels, such
In healthcare, the three GS1 standards will help as medical devices, ranging from syringes to pacemakers,
electronically describe important information needed to reducing transaction errors and inefficiencies.
effectively move and track a product throughout the supply • Global Location Number (GLN) – A GS1 standard used
chain.  They will also help communicate that information to uniquely identify locations and legal entities from
between different information systems within a hospital, or manufacturers, distributors, hospitals, all the way down
between a hospital and supplier, at any point in the supply to nursing stations. Reducing transaction errors while
chain and in any direction.  ensuring that the right product, procedure, and/or
treatment is delivered to the right location.
Back to Basics • Global Data Synchronization Network® (GDSN®) – Stores
Basic information technology elements must come into GLNs, GTINs and associated product definitions or
play in healthcare in order to make a real difference on how attributes, allowing users to access accurate product
efficient the industry can become.  It is not enough, for information including changes and updates. The GDSN is
example, to create an EHR when, right now, that EHR may used by more than 18,000 companies for more than three
not have the accurate information about which products a million products.

8 2009/2010 GS1 Healthcare Reference Book

 Change has finally come: U.S. Healthcare industry
to implement common data standards to improve safety, reduce costs

• 2010 – Require recognition and use of GLN by all providers

Patient Safety and suppliers.
• 2012 – Require GTIN for all products from the suppliers;
Healthcare Supply Chain Efficiency require the use of GTINs by all providers

Electronic Record Management

Coordinating GLN adoption by Members & Suppliers
(Bar Codes, Data Matrix, RFID)

(e-Records, e-Prescriptions)
Automatic Data Capture

(EDI/XML Transactions)

(e-Pedigree, Recalls)
Equipment Tracking
100% GLN Adoption Timeline
e-Commerce

Traceability
Assets & 80%
f
no
sio ms
i n clu Ter
’s
60% Members by ier
ed em s
ort Pr ent
u pp ithin eem
S r
on ts w Ag
pti en ns
40% Ado irem ditio
N u n
GL N req & Co
GL

Standardized Product Definition (GDSN®)

20% Suppliers

Standardized Location Identification (GLN)

Calendar Year 2008 2009 2010 2011 2012
Standardized Product Identification (GTIN®)

Standardization Interoperability GTIN Adoption Timeline for Suppliers

100% GTIN Adoption Timeline

GS1 Healthcare US describes its standards as the foundation
needed to build a safe and solid supply chain in healthcare. 80%
of
With the 3 Gs at its foundation, hospitals can perform many ion s
c lus Term Require
in ’s
60% by ier for All
effective supply chain functions, such as automatic data capture, r ted Prem nts Vendors
o e
u pp ithin eem
S r
e-commerce, electronic records management and other t i on nts w s Ag
p e n
40% do rem itio Require for New
applications that serve as the pillars to improve patient quality N A ui nd
GL N req & Co Vendors
GL
and safety, as well as efficiency in the supply chain. 20% Request from Vendors

Pilot Phases & Marketing

Premier’s iterative approach toward comprehensive
Calendar Year 2008 2009 2010 2011 2012
standards adoption:
• 2008 – Launch and education; modify contract to include
requirements for standards compliance. Premier’s GLN initiative targets 244 member hospitals, and
• 2009 – Request that providers and suppliers recognize as of Feb. 2009 is 54% complete. Premier is reaching out to
GLNs and that the suppliers begin to register GTINs for their representatives from 51 supplier partners to work with them to
products. get medical products registered for GTINs.

Author

Joe Pleasant is chief information officer and senior vice presi- improve healthcare quality and affordability. Premier maintains
dent of the Premier healthcare alliance. In his role, the nation’s most comprehensive repository of clinical,
Mr. Pleasant oversees Premier’s information systems infrastructure financial and outcomes information and operates a leading
that includes legacy, enterprise and Web-enabled offerings. Pre- healthcare purchasing network. A world leader in helping
mier participates in the DoD’s ongoing pilot testing the GDSN as deliver measurable improvements in care, Premier works with
a potential industry product data utility, and serves on the Board the Centers for Medicare & Medicaid Services and the United
of Governors for GS1 US. Kingdom’s National Health Service North West to improve
The Premier healthcare alliance is more than 2,100 U.S. hospitals hospital performance. Premier has offices in San Diego, Charlotte,
and 54,000-plus other healthcare sites working together to N.C., Philadelphia and Washington.

2009/2010 GS1 Healthcare Reference Book 9

P. R. China

Shanghai Food and Drug Administration

Implementation of a post-market traceability
program for implantable medical devices adopting
unique device identification

Abstract

This article discusses the distribution and traceability model of

Implantable Medical Devices (IMD) for post-market surveillance purposes,
and the IT and automatic identification technology that has been used in
Article by Liang Yan
the supply chain to complete post-market tracking in Shanghai. To build
up this system successfully, it was necessary to establish a Unique Device
Identification (UDI) for IMD’s, based on GS1 Standards, to define the
minimum information in the tracking process, and to establish a central
data pool to support automatic reading in the hospital management
system. Meanwhile it is necessary to have a Shanghai FDA monitor
platform to collect the traceability information from the end user. This
article also contains a real case study that took place in Shanghai.

Introduction that the actual effect of these legal measures fell short of
Implantable Medical Devices (IMD) pose the highest expectations. The following three major aspects have caused
potential risk among medical devices, so they are subject traceability problems:
to the most stringent management in the medical device • Firstly, basic IMD use information recorded during the
regulatory system of each country, regardless of pre-market process was inaccurate.
approval or post-market surveillance. Due to the high risk • Secondly, manufacturers could hardly collect the actual
and high profit, such products can cause other disorderly use data from the hospital, so they could not fulfil their
management problems in their sales, purchase, pricing and legal post-market responsibilities.
service links, and even lead to injuries or doctor-patient • Thirdly, the information of IMD use was not transparent,
disputes, so they raise serious concerns by the general which could not safeguard patients’ safety, rights and
public and the regulatory authorities. Shanghai began interests.
adopting Unique Device Identification (UDI) using GS1
Standards in 2007, and it was the first in China to set up a The most practical and effective means to address the
tracking system that links IMDs directly to patients. post-market traceability of these high risk medical devices is
to make use of current computer/IT technology and allow
Computerisation is an effective pathway to different legal entities to easily share IMD use data under
address post-market tracking the existing legal framework. The key to setting up such
Shanghai began to take legal supervisory measures on IMDs computerised tracking system is to establish a standards-
as of 2002, and a follow-up study after three years showed based UDI, to determine the traceability management mode,
and to set up a feasible tracking system.

10 2009/2010 GS1 Healthcare Reference Book

 Shanghai Food and Drug Administration – Implementation of a post-market traceability
program for implantable medical devices adopting unique device identification

Standards for IMD identification product name, specification and packing level. The
To establish a UDI system for IMD’s, it was necessary secondary barcodes are used to indicate key information
to understand the basic requirements of its use, then of the product, including product’s lot/batch number,
determine the UDI coding rules, and finally determine the and key dates, i.e. expiration date or manufacturing date;
scope of traceability information.
Key traceability information
Basic use requirements: in the IMD traceability system
1) UDI should be applied to any possible place of use; The information provided in the IMD traceability system
2) UDI should be able to remain independent from the needs to enable the effective handling of adverse events
above place of use; after their occurrence, such as product recall and patient
3) UDI should meet the compatibility requirements of identification.
current automatic reading technology environments
and should be adaptable to current legal environments; Accurately recording the UDI and patient ID is the
4) UDI should be based on a design structure with clear most important link
validation records and good stability and reliability; To track the adverse event related to IMDs, regulators need
5) UDI should have good technological expandability and the following basic information:
be able to accommodate various data media; 1) Basic information on product’s use;
6) UDI should meet the requirement for simple operations, 2) Information on the specific product involved in the
without multiple conversions during its use; adverse event;
7) The symbols making up the UDI should be easy to use; 3) Range of products that may have the same quality
8) UDI should be able to adapt to potential changes problem;
that may occur in the production and management 4) Patients involved in the product in question;
environments; 5) Location of the product(s) in question that have not yet
9) UDI should be affordable for organisations to implement been used.
and the benefits should outweigh the burdens;
10) UDI should comply with the operating rules of other Simply speaking, when we deal with an adverse event, we
regulations prevailing in the international market, such should use the UDI information of the product involved in
as the World Trade Organisation (WTO) rules. the adverse event and identify the patients involved; then
exercise control over the product held in inventory and
Shanghai UDI rules for IMD’s bring the potential injuries under effective control in the
1) Using linear barcodes. The technical environment for earliest possible time.
overall implementation of 2D barcodes and RFID is not
yet mature, and in order to meet the current urgent To enable tracing to the patients, it is critical to record the
need of tracking high risk medical device adverse events, UDI and patient identification (PID) at the time of use, and
we started from linear barcodes, and will then gradually keep all the information in the quality system of the supplier
develop into 2D barcodes and RFID; and the hospital. Shanghai stipulates that upon completion
2) Using the GS1 or HIBC coding standards. To allow every of any IMDs surgical operation, the automatic identification
supplier to quickly implement the UDI system in the of a UDI and recording of all relevant data of the patient
start-up phase, suppliers were allowed to choose either shall be completed and linked outside the operation room
GS1 or HIBC barcodes. This rule may be changed later of the hospital.
in the nationwide implementation of the UDI tracking
system to simplify the technical system. (For reference: Minimum traceability information
medical products that do not need to be traced can To trace an IMD to a patient, the UDI needs to be associated
directly adopt the GS1 EAN13 barcode as used in the with the following supporting information: product
Chinese supermarkets); name, model, specification, lot number or serial number,
3) Using primary and secondary barcodes; the primary registration certificate number, expiration date of the
barcodes are used to identify products and contain registration certificate, manufacturer’s name, name of the
information on the country of origin, manufacturer, after-sales service company of the imported product, and

2009/2010 GS1 Healthcare Reference Book 11

Shanghai Food and Drug Administration – Implementation of a post-market traceability
program for implantable medical devices adopting unique device identification

name of the final distributor. Patient ID information should

Figure 1: IMDs sales channel and device
include the hospital’s name, the patient’s inpatient number,
use data reporting channel
the patient’s name, sex, name of the surgical operation,
place of operation, date of operation, surgeon performing Manufacturers Final distributors
the operation, the quantity of devices used and so on.

The basic information relevant to a product is generated FDA

by linking the UDI directly to the database; the information surveillance

of the lot number/serial number and expiration date of the

product is generated after the second barcode is scanned;
the medical information of a patient needs to be extracted Hospitals
from the hospital information system through the patient ID.

Information on product pricing can be included for Manufacturers collects Hospital reports use
use data from FDA data to FDA surveillance
additional purposes. But for a system that needs to run surveillance platform platform
for a long period of time and to gather information on a
continuous basis, the principle of “the least information, The outside of the triangle as shown in Fig. 1 is the basic
the cost-effective” shall be followed in setting basic sales channel of IMDs where manufacturers sell their
management information requirements. products to hospitals directly or through a distributing chain
and final distributors.
Implementation of the IMD traceability
system in Shanghai Inside the above triangle is a data reporting platform
Shanghai started to implement the IMD traceability system administered by the Shanghai FDA/health authorities.
in November 2006 according to the above architecture and Hospitals report data relevant to the use of IMDs to this
management principles. The tracking system covers more platform, and through which, manufacturers / distributors
than 100 hospitals using IMDs in Shanghai, and the IMDs can retrieve information about the use of their products.
included high-risk devices such as orthopaedic internal This addresses the problem encountered by regulatory
fixation devices, orthopaedic implants, synthetic crystals, authorities that manufacturers can hardly obtain data
breast implants, pacemakers, heart valves, stents and relevant to the use of their IMDs from hospitals.
catheters. By June 2008, and through manual and automatic
online reporting, the data reporting platform of the tracking If an IMD manufacturer doubts the data available on the
system has gathered more than 175,000 entries of use data. reporting platform and refuses to recognize such data,
Data analysis showed that the tracking system plays a crucial the post-operation safety of patients using such IMD can
role in addressing the post-market surveillance of those hardly be assured, so the government will discover it and
high-risk medical devices, preventing the occurrence of supervision should step in as soon as possible.
injury events, and managing such events.
Implementation scheme
Triangular sales and supervisory model for IMDs The middle part in the schematic diagram of the tracking
Shanghai developed a triangular sales and supervisory system in Fig. 2 is consistent with the triangular sales model
model in the exploitation of IMDs. Theoretically speaking, it described in Fig. 1. Enterprises sell their products to hospitals
is the most simplified traceability management model directly or through a sales chain.
(See Fig. 1).
Upon completion of a surgical operation, the hospital
records the UDI using automatic identification technologies.
The product information will be reported together with the
patient information, collected from the Hospital Information
System (HIS) to the Shanghai FDA health data reporting
platform. At the same time, the information is linked to the

12 2009/2010 GS1 Healthcare Reference Book

 Shanghai Food and Drug Administration – Implementation of a post-market traceability
program for implantable medical devices adopting unique device identification

Figure 1: Schematic diagram of IMD tracking system

Submit sales data

Data exchange platform Hospital downloads
product data

Identify data
Sales reporting
linked to
finance
Manufacturer

Hospital finance
Surgical records
Hospital data
Entrusted sales chain

Direct selling by enterprise

Enterprise Hospital data Automatically identify

collects data reporting and record data
FDA monitor platform

hospital’s financial management system to manage financial 2) Entrusted by IMD manufacturers, the IMD distributors
records. The manufacturer can obtain hospital use data via shall be responsible for providing the traceability
the reporting platform. information on the IMDs, and take their own initiatives to
assist manufacturers in handling those potential adverse
To support hospitals in automatically reading the UDI, a events. IMD distributors shall not make UDI’s without
product data exchange platform is set up in the tracking prior authorization of manufacturers. UDI making must
system. Manufacturers can submit their product data to be authorized by and the entire process must be under
the hospital’s database, and can control distributors and the control of the manufacturer’s quality system.
hospitals directly and define the scope of the products sold 3) Hospitals shall establish automatic identification
to and used in the hospitals. management, registration and reporting system for UDI’s
of IMD’s, and keep the use records of such patients.
Legal responsibilities of each 4) Patients shall obtain relevant information of the IMDs.
responsible party Hospitals and manufacturers shall take their own
In post-market management, the depth of government initiatives to provide such information.
surveillance in the tracking system should be different as 5) In order to safeguard the interests of the public, the
risks related to products and treatments are different. Each government shall assume the supervisory and regulatory
party in the tracking system shall undertake the following responsibilities in the tracking system.
responsibilities:
In the tracking system, manufactures are required to meet
1) IMD manufacturers (or the domestic legal after-sales the UDI requirements in labelling their product, and medical
service institutions of imported products designated institutions to implement automatic UDI and recording
by manufacturers) shall be fully responsible for the system. These are the core links to ensure successful product
quality of their products after market release, for the traceability.
management and implementation of UDI marking,
tracking, recall of their products and handling of patient
injuries in adverse events, and for gathering and keeping
the use data through the health data reporting platform.

2009/2010 GS1 Healthcare Reference Book 13

Shanghai Food and Drug Administration – Implementation of a post-market traceability
program for implantable medical devices adopting unique device identification

Discussion and suggestions on promoting

a worldwide uniform tracking system
In order to enable effective worldwide tracking of key
medical devices, we suggest that the domestic market
tracking efforts of each country should keep pace with
those in the rest of the world. The following work should be
promoted and completed under the Global Harmonisation
Task Force’s (GHTF) medical device regulatory framework:

1) To coordinate the development of a globally uniform

UDI system and its coding standard, allowing automatic
identification equipment to be compatible with each
other to the maximum extent;
2) To establish a global basic tracking model. The tracking
model proposed by Shanghai can be utilised and
discussed;
3) To coordinate the establishment of a unified scope of
important and basic traceability information specific to
medical devices; and medical device reporting and handling system, change the
4) To facilitate the solution of a global nomenclature for sales model of consumable medical devices, greatly improve
medical devices as soon as possible; the globally unified the transparency of information on those high-risk medical
nomenclature system should be used together with devices, improve the safety of medical devices used by
the UDI system in the global tracking system so as to patients, and play an active role in speeding up hospital’s
improve the global medical devices reporting efficiency. informatisation construction and improving the efficiency
of hospital’s consumables management. We are willing to
The establishment of the above medical device tracking work with the rest of the world to establish a new global
system, according to our estimation, will thoroughly change mechanism beneficial to patient safety management as
the post-market surveillance of each country for medical early as possible.
devices, improve the pre-warning and reporting levels
of medical devices, improve the efficiency of the adverse

Author

Liang Yan is the head of Regulatory Affairs Division, and the served as head of the Science and Technology Department
International Cooperation Division and the former Head of of the Shanghai Pharmaceutical Administration Bureau, for
the Medical Device Registration Division of the Shanghai Food Shanghai’s pharmaceutical and medical devices industry research
and Drug Administration. Mr. Yan has more than 30 years and development of new technology and products. In 1989,
working experience in the medical-related administration of he organized a group for drafting China’s first medical devices
the Shanghai Municipal Government. Before the beginning regulations. Afterwards, he continued to work with the drafting
of the Chinese Reformation, he was engaged in innovation and implementation of China Medical Devices Regulation
and development of medical devices technology in Shanghai in Classification Rules, Medical Devices Registration, Medical
Medical Industry Co (SMIC). After the Chinese Reformation he Devices Recall area.

14 2009/2010 GS1 Healthcare Reference Book

 Australia

Building traceability in Australian healthcare

Abstract

Concerned by a lack of traceability processes within the Australian

healthcare industry, Clifford Hallam Healthcare (CH2), Australia’s largest
national Healthcare Service Provider, has embarked on a 10-year scalable
Article by Ged Halstead
plan to ensure our facilities have total supply chain integrity through use
of the GS1 System. By implementing a Radio Frequency based bar code
scanning inventory management system, and electronic messaging with
key suppliers, we have made significant gains in supply-chain efficiencies
such as reduced pick errors, faster put away, reduced backorders as well as
improved data quality and improved logistics partnerships which leads to
more favourable working capital investment ratios.

Background CH2 must comply with a number of Acts and Regulations

Clifford Hallam Healthcare (CH2) is Australia’s largest national at both Federal and State level and operates in a highly
Healthcare Service Provider. Trading with more than 11,000 regulated environment. Our warehouses are temperature
facilities in all states and territories, the company has been controlled and dust free, ensuring all products are kept
in business for 35 years and has developed a business constantly in a clean and controlled environment (25 deg
management system that meets the specific requirements Celsius or below) all year round.
of AS/NZS ISO 9001:2008.

CH2 operates seven warehouses nationally. All carry a

comprehensive range of medical and surgical products,
pharmaceuticals, general hospital consumable items
and healthcare equipment. Our customers are located in
metropolitan, regional and rural areas and include public
and private hospitals, nursing homes, general practitioners,
specialists, day surgeries, diagnostic imaging, pathologists,
veterinarians, physiotherapists as well as Federal and State
Government bodies such as the Armed and Emergency
Services and the Justice Departments. CH2 now also delivers
to home enteral nutrition (HEN) patients.
Traceability to Enable Efficient Recall –
The company has 32,000 catalogue lines (or SKUs) offered, of The End Goal
which approximately half are stock lines. CH2: In 2008 there were 24 therapeutic goods recalls in Australia
• Delivers up to 320,000 lines per month based on notifications provided to the Minister for
• Picks and ships over 3 million units per month Competition Policy and Consumer Affairs. For CH2, recalls
• Fulfils over 40,000 orders per month can vary between full product recalls, single or multiple
• Has internal pick rates exceeding 96% and a Delivery in batches, supplier withdrawals or safety alerts. Some recalls
Full on Time (DIFOT) target of 95% may affect only one branch while others may affect every
branch in Australia.

2009/2010 GS1 Healthcare Reference Book 15

Building traceability in Australian healthcare

CH2 follows Australia’s Therapeutic Goods Administration Along with other areas of focus, this has meant potentially
guideline, Uniform Recall Procedure for Therapeutic Goods1, extending the concept of a trade item to ‘unit of use’, which
when taking recall action. In the event of a recall the is the level of trade item dispensed to the patient in a
following procedure is adhered to: hospital environment.
• A manual check of CH2 branches is undertaken to
determine which sites have affected stock. CH2 is also working with GS1 to help engage their suppliers
• All affected stock on hand is quarantined ensuring to implement, where possible, GS1 Global Trade Item
further supply to customers is prevented. Numbers (GTINs) for product identification, Global Location
• A report indicating customers who have purchased Numbers (GLNs) as primary delivery/pricing records and
the product over a nominated period is sent to key Serial Shipping Container Codes (SSCCs) for tracking logistic
personnel at CH2. unit movement (warehousing and distribution).
• The relevant customers are notified and are required to
take their own action to collect any stock in question. Supplier Engagement – eMessaging
• The return and replacement of the recalled product is In 2007 none of CH2’s 900-plus suppliers were undertaking
subject to the procedure set out by the manufacturer. electronic messaging with our organisation. As the first
step in their supply-chain transformation, CH2 initiated
Currently, the processes for supply of medical and eMessaging (using GS1’s EANCOM purchase order,
pharmaceutical products in Australia are mainly manual purchase order response) with seven suppliers, using GTINs
and this has led to concerns that both suppliers and their as the primary item identifier and GLNs as the primary
customers can not easily identify and locate products in location identifier. Within two months of eCommerce
the case of a recall. Such concerns have prompted CH2 to implementation 100 per cent data accuracy rates were
initiate a 10-year plan working with suppliers and customers achieved in the messages exchanged, and much of this was
to ensure that supply chain integrity is achieved. due to the GTIN being used as the unique product identifier.

Right now there is no easy way for many of our customers The use of the GTIN has provided another notable benefit as
to locate products in the case of a recall without employees CH2 and its partners are now starting to overcome an issue
going into each and every ward, or hospital pharmacy or op- that continues to plague the healthcare sector- differing
erating suite and physically checking if the product is there. Units of Measure.
This leaves room for error and when you are dealing with
potential risk to human life, there can be no margin for error. This is having a flow-on effect throughout the CH2 Supply
Chain and has put our company in a stronger position to
In Australia we do not have a mandate for suppliers to use achieve Delivered In-Full, On-Time to Quality (DIFOTQ) with
the GS1 System for product identification. This is a voluntary our customers – a key objective for 2009. This is consistent
system and CH2 are urging companies to adopt the GS1 with our goal of having the right product in the right place
System so we can ultimately improve patient safety. at the right time.

Working with GS1 Australia The company continues to progress, aiming for all suppliers
To help drive this 10 year plan, CH2 has been actively to be trading via electronic messaging, including providing
working with GS1 Australia. CH2 is the chair of the GS1 Despatch Advices with lot and expiry dates as well as
Healthcare User Group (HUG) Australasia, the local chapter SSCC labels. If this goal is achieved, CH2 estimates a 45%
of GS1 Healthcare (the GS1 global healthcare user group). reduction in receiving time.
HUG Australasia is one of several such groups around the
world reviewing, developing and refining the GS1 System to Warehouse efficiency
ensure it is applicable for all aspects of the global healthcare CH2 had identified that our warehouse processes were
sector while remaining relevant to other industry sectors. hampered by the inability to easily track goods. As the next
logical step in our supply chain transformation, we identified
1 Uniform Recall Procedure for Therapeutic Goods, Australian Government, the need to implement scanning of products on receipt,
Department of Health and Ageing, Therapeutic Goods, © Commonwealth of
Australia 2004.
put-away, picking and packing.

16 2009/2010 GS1 Healthcare Reference Book

 Ensure there are GS1
GTINs allocated and where
appropriate Bar Codes on
all products at all levels of
packaging

CH2 worked with those suppliers already using GS1 Bar Cottman was a business with 50,000 line items, very limited
Codes to ensure these were entered in our database and eMessaging capability, no scanning and no use of the GS1
then began their scanning based on these products. For System. This had to be merged with CH2’s 32,000 line items.
those products without bar codes, CH2 applied internal
identifiers and bar codes at carton level so we could track As a result of the work CH2 had already done to implement
products and their location in our warehouses. Applying GS1 Bar Codes and eMessaging with suppliers, we
these internal labels has been clearly recognised as a non- found that we were in a strong position to merge the
value adding process, and elimination of this process by two businesses using the scanning processes we had
provision of supplier GS1 Bar Codes, has been identified as a implemented in our existing warehouses.
key focus moving forward.
In what amounts to proof that using proprietary item
Of the CH2 suppliers, approximately 240 are now providing identification does not cross-translate within the industry,
GS1 GTINs and appropriate bar codes, however it is CH2 were only able to match 3.12% of items between the
recognised that there is much more work to be done to two businesses using their vendor part number. This was a
engage the remainder of the 900 suppliers. To address this, startling revelation and is a strong reason for the industry to
CH2 is partnering with GS1 and commencing a supplier get on board to use GTINs for item identification. The advent
engagement and education program. of the National Product Catalogue meant that there was
now another valuable data source that was useful for the
The ultimate goal is to have products carrying bar codes, as data matching exercise.
the business benefit is clear. With the bar code scanning proc-
esses in place CH2 warehouse pickers are now picking and CH2’s purpose-built warehouse in South Australia was the
packing up to 400 lines a day, a very significant productivity company’s first site for physically merging the inventory of
improvement compared to the pre-scanning days. the two businesses. As a result of this merge, 500 pallets
were moved in a day and put into bar coded locations. The
Organisational Consolidation merger was completed in 1.5 days and scan packing was
In early 2008 CH2 acquired the Cottman Australia business, then enabled in the warehouse. The Western Australian
extending their supply offering to other trading partners. operations were merged next and by using scanners to

2009/2010 GS1 Healthcare Reference Book 17

Building traceability in Australian healthcare

ensure inventory integrity, CH2 was able to complete the

operation in a weekend. It is estimated that CH2 would have
taken twice as long to merge the operations if the scanning
process had not been in place.

Customer focus
Turning to the customer side of our business, CH2 has
initiated a multi-streamed eMessaging protocol using both
GS1 XML and GS1 EANCOM.
CH2 is confident that improved data interchange and
The first stream entails establishing eMessaging with public collaboration between wholesalers and manufacturers and
and private hospitals. This involves a business-to-business based on the GS1 standards will reduce stock holding across
(B2B) model with hospital pharmacy customers, using the the entire supply chain and ultimately lead to improved
GS1 System based on EANCOM messaging standards for pur- patient safety.
chase orders, purchase order response and despatch advice.
The backbone of this system is accurate and reliable product
The second stream relates to CH2’s proprietary online data and CH2 is working to implement the National Product
ordering system - Simple Order System (SOS). This system is Catalogue, the Australian Healthcare data synchronisation
used by the majority of customers not using EANCOM. CH2 solution hosted on GS1net, both as a recipient of supplier
is moving SOS to the GS1 standards and we have recently data and a source of data to their customers.
added a GTIN search capability.
CH2 understands the value of quality data and is committed
Already, Melbourne’s The Alfred Hospital Pharmacy, a to implementing the GS1 System through our business
400-bed, acute tertiary referral hospital renowned for its and with our partners. The use of the GS1 standards for
specialist services, uses the SOS ordering system with eMessaging, GTINs, GLNs and SSCCs are paramount to our
products identified by GTINs. industry moving forward. We believe the uplift in quality
systems will lead to improved patient safety.
Looking forward
CH2 will continue to drive the implementation of GS1 This is a very long journey for the Australian healthcare sec-
eMessaging with suppliers and encourage them to apply tor and we are just at the beginning. As a middle player we
GS1 Bar Codes to all levels of packaging as well as SSCCs to see suppliers taking steps to implement the GS1 System and
logistic units. Our vision includes being able to receive batch now hospitals are making demands on us for a system that
and expiry date information in electronic messages and to will give them better inventory management and traceabil-
have that information physically bar coded on the products. ity. This work requires patience, persistence and passion.

Author

Ged Halstead is the Chief Information Officer for CH2. He has in which Ged has implemented financial, distribution and
over 20 years experience implementing ERP systems for a broad warehouse systems are petro-chemical, print media, grocery
range of industries in Australia and the United States. Ged has wholesale and frozen foods.
spent 12 years in the IT consulting space, principally engaged Ged is actively involved in the Healthcare standards
as a project manager and practice leader. He has 10 years in the community, notably as the current Chair of the GS1Healthcare
healthcare industry delivering solutions for global leading brands User Group Australasia, on the leadership team for the Monash
in both medical devices companies here and abroad, and to Medical Project, a member of the GS1Net advisory group, as well
medical services companies and pharmaceutical manufacturers as participating on advisory groups for a number of eCommerce
in Melbourne, Sydney and Auckland. Other industry sectors exchanges.

18 2009/2010 GS1 Healthcare Reference Book

 France

Unique Device Identification of

surgical instruments by DataMatrix 2D barcodes

Abstract

The Robert Ballanger Hospital is a 650 bed intercity hospital. It has

developed a project of Unique Device Identification (UDI) for surgical
instruments and clinical services instruments. Over three years they will
identify 10,000 operating theatre instruments using laser DataMatrix 2D Article by Georges Nicolaos (left photo),
barcodes, as well as 12,000 clinical services instruments. Marine Tournoud, Yasmine Hassani,
Jeanne Mignon, Frédérique
The initial results, using laser technology to identify small instruments, Frémont (right photo) and
were very promising. However, the project highlighted the necessity for Alexandra Fabreguettes
regulation of the UDI. For this project EAN 128 codes were chosen, but
other hospitals in France chose to use their own code. A regulation of
the use of UDI would provide clarity and avoid a situation where every
hospital develops its own UDI.

Introduction can be traced from the point of return to the unit through
In France, as in other countries around the world, UDI of to their distribution to clinical services. The individual steps
surgical instruments is not yet regulated1. However, several of the process are presented in the figure 1 and for each of
French hospitals are undertaking their own UDI projects. these steps, the agents must identify themselves.

The Robert Ballanger Hospital is an intercity hospital. It has

Figure 1: Sterilization process
650 beds: 450 medical, surgical and maternity beds and 200
psychiatry beds. 30 patient operations are undertaken in the
8 room operating theatre per day. The sterilization unit of Operating room Sterilization unit

the hospital sterilizes 120,000 products per year. Reception Cleaning

Pre-cleaning

This case study presents the Robert Ballanger Hospital UDI

project, and highlights two major considerations:
1. the kind of identifier and
2. the requirement of standardised UDI.
Surgery Distribution
intervention sterilization Packaging
The Robert Ballanger Hospital Project
In the hospital, 9,597 sterile medical devices are in
circulation. 7,381 in clinical services and 2,216 in the
operating theatre, contained in 724 surgical boxes.

Since 2005, the traceability of all sterile medical devices is

the responsibility of the sterilization unit, using the t-doc Up to December 2008 traceability was at the surgical box
software (Getinge, les Ulis, France). These medical devices level rather than the individual instruments within them.

2009/2010 GS1 Healthcare Reference Book 19

Unique Device Identification
of surgical instruments by DataMatrix 2D barcodes

What kind of carrier will we use?

The two major kinds of carrier are Radio Frequency Identifi-
cation (RFID) tags and DataMatrix 2D barcodes (figure 2).

Figure 2: Different tags

RFID micropercusion DataMatrix

2D barcodes

Consequently, if the instruments in the box changed, that laser DataMatrix 2D keydot DataMatrix 2D
barcodes barcodes
change was not traceable. The decision was therefore
taken to trace the individual instruments in addition to the
surgical boxes. RFID tags and DataMatrix 2D barcodes are the two carriers
that can be used in the operating theatre and sterilization
Several important points were considered before the units. RFID tags on instruments could help avoid them being
project: left inside the patient2-3. This system could also assist in the
1. What level of traceability do we want? exchange of data between hospitals and to confirm the
2. What kind of carrier will we use? contents of surgical boxes.
3. Which instruments will we identify?
4. What kind of code will we put on each carrier? DataMatrix 2D barcodes are represented in 2 dimensions
(2D). They can be applied to instruments directly with a label
What level of traceability do we want? or marking by micropercussion or laser.
In France, instruments are dedicated to a box. When an
agent is assembling a box, the t-doc software displays its For this project we chose the most pragmatic system of
composition on a computer screen and the agent scans identifying the surgical instruments with a DataMatrix 2D
the instruments and must only include the associated barcodes. 3 major reasons lead to this choice:
instruments into the box. 1. the ease of laser marking existing or branded new
instruments; Indeed, 500 instruments were industrially
This concept is very simple; it is easy to assemble surgical marked per week.
boxes and to identify the previous procedure/patient where 2. the cost of this kind of marking. In fact, a single laser
the box was used. But there is little difference between this mark costs between 2 and 3 Euros, whilst an RFID tag
level of traceability and the traceability of a box. costs approximately 7 Euros4.
3. the existence of software that enables this kind of
In the Robert Ballanger hospital instruments are dedicated traceability.
to a box, but it is possible to put the instrument in another
box. But, as the level of identification is at the individual For clinical services instruments, cost effective keydots were
instrument level, traceability can be done on the box, for chosen.
each instrument or for each box that included a particular
instrument.

20 2009/2010 GS1 Healthcare Reference Book

 Unique Device Identification
of surgical instruments by DataMatrix 2D barcodes

Which instruments will we identify?

The decision was to identify surgical instruments and clinical
services instruments. For clinical services instruments, all
the instruments would be identified with Keydots. For
surgical instruments, the simple strategy was to identify the
instruments with the highest usage. For example, 5 types
of surgical boxes represent 12% of usage. Identifying 10,000
surgical instruments equated to 80% of usage.

What kind of code we will put

on each carrier?
Due to the importance of instrument traceability, the
Food and Drug Administration, the European Union or the
Japanese authorities are leading reflections in this context1.
Based on these international reflections, it was determined It was therefore decided to use GS1 standards. For keydots,
that UDI must be based on international standards, like the the code is only an identification number.
GS1 System of Standards, rather than local codes specific to
each hospital. In conclusion, we think that French hospitals are in advance
on the UDI, but we also think that they must integrate two
Most French hospitals are developing their own code important aspects of UDI:
using micropercusion DataMatrix 2D barcodes. But using a 1. the international reflections on UDI to adopt an
proprietary code puts the identification responsibility solely international standard like GS1, and not a local code
on the hospital. 2. the type of UDI - the DataMatrix 2D barcode is actually
the most pragmatic system.

References

1. Medical devices and AIDC, UDI, traceability, efficiencies, global standards: Fact, future or fantasy? Eucomed, Medtech Forum, Bruxelles, 2008.
2. RFID tags help alert surgeons to problems. Healthcare Benchmarks Qual Improv 2006; 13: 118-20.
3. Rogers A, Jones E, Oleynikov D. Radio frequency identification (RFID) applied to surgical sponges. Surg Endosc 2007; 21:1235-7.
4. Landanger B. Snitem Info 2008; 175: 5.

Authors

Georges Nicolaos is Head of the Sterilisation Unit of the Frédérique Frémont is Organisation Engineer at C.H.I Robert
Robert Ballanger Hospital. Georges is also Vice-Chairman of the Ballanger. Prior to joining Robert Ballanger Hospital, Frédérique
committee for the prevention of the nosocomial infections and worked for more than 10 years in healthcare consulting as Senior
member of the Committee for the Protection of Person in the Manager in Ernst & Young Healthcare and as Project Director at
biomedical research. L.F.B. (plasma-derived medicinal products and “biotech” products).
Frédérique is a member of Cologh (Hospital group member of the
French Logistic Association) and GS1 Healthcare France.

2009/2010 GS1 Healthcare Reference Book 21

U.K.

The NHS Procurement eEnablement Programme –

Using information to deliver better healthcare

Abstract

Common standards hold the key to unlocking the benefits of

procurement eEnablement in the NHS. This article describes the
importance of information in the healthcare supply network and provides
Article by Rachel Hodson-Gibbons
an overview of the NHS Procurement eEnablement Programme.

Healthcare and information An example from the English NHS illustrates this point well.
Healthcare is an information intensive environment and the Figure 1 provides an extract from the NHS Purchasing and
availability of quality information is essential for the delivery Supply’s Agency’s pharmacy database which collates details
of safe and effective healthcare services. Decisions based of orders placed by NHS Trusts. The database contains 130
on poor quality information provide ineffective healthcare different descriptions, 30 of which are shown in figure 1, of
services which adversely affect the outcome of treatment a single product, Bleomycin 15,000 unit powder solution for
for patients and provide the NHS with a significant and injection vials.
avoidable cost.
The lack of a common commercial and procurement data
The healthcare service in the UK is provided by a large standards in the NHS means that the analysis of expenditure
number of organisations involving the private sector, the and demand requirements across organisations is very costly
NHS and an increasing use of the retail sector. An equally in terms of time and resources. Without standards to accurately
large number of suppliers of goods and services supply into identify products and suppliers the accuracy can never be
this network of healthcare providers. Purchasing and supply certain and visibility across the NHS is limited.
is essentially about relationships between organisations and
processes; more effective processes and better relationships Effective information is the key foundation to an effective
provide a higher quality supply chain. supply chain and effective healthcare.

To achieve stronger and effective processes and Processes and data standards
relationships, within and between organisations access to The implementation of common data standards across the
high quality information is required. To enable the effective procurement and commercial systems by NHS organisations
delivery of high quality information organisations on the and its suppliers also enables information to be easily trans-
buy and supply sides of the healthcare network must be ferred between systems. This enables interoperability between
able to share data and order to achieve this common data systems, allowing automation which reduces the resources re-
standards are required. quired, removes errors, increases compliance and reduces risk.

Current NHS position Beyond the business benefits the implementation of common
The NHS has adopted a fragmented approach to the procurement data standards enables traceability and this
management of procurement and commercial information directly contributes to improvements in patient safety. This
and systems and consequently the lack of common data was demonstrated in Coding for Success – simple technology
standards has created many data silos. Data is available in very for safer patient care, a Department of Health policy document
large volumes however quality information is in short supply. published in February 2007.

22 2009/2010 GS1 Healthcare Reference Book

 The NHS Procurement eEnablement Programme –
Using information to deliver better healthcare

Figure 1

Procurement eEnablement technologies of this activity; the text inside the arrows describes the
Procurement eEnablement is the application of information processes undertaken and the text outside the arrows
and communication technologies to the commercial and describes the eEnablement technologies.
procurement functions. Figure 2 provides an overview

Figure 2

Sourcing Purchase
to pay

Process steps
eEnablement technologies

2009/2010 GS1 Healthcare Reference Book 23

The NHS Procurement eEnablement Programme –
Using information to deliver better healthcare

Procurement eEnablement technologies are important The outputs of the programme are delivered through a
to the NHS as to be effective they demand common data range of projects which have two levels of delivery:
standards across the NHS organisations and their suppliers. • Level 1 projects establish common data and business
Implemented procurement eEnablement technologies message standards for commercial and procurement
provide the NHS with an important opportunity to systems; provide a library of knowledge and guidance in
significantly enhance its capability to manage procurement conjunction with a range of tools for the NHS to improve
information, improve its commercial and procurement awareness and understanding.
processes and remove waste and duplication. • Level 2 projects drive the delivery of procurement
eEnablement capability into the NHS by directly
Procurement eEnablement and the NHS providing resources to work directly with NHS
Though the NHS has been using procurement eEnablement organisations, suppliers and technology providers to
technologies since the early 1990’s the approach to achieve the following:
the implementation of these has been fragmented. – The capability for all procurement eEnablement
Consequently the NHS has a wide range of standards in use systems in the NHS market to support NHS standards
and therefore limited interoperability between systems and and interoperability requirements.
little visibility of its expenditure across the network. The NHS – The capability within NHS organisations to make
has also failed to exploit sensible once-only opportunities appropriate use of procurement eEnablement
that procurement eEnablement technologies offer; such as technologies.
the management of product data for electronic catalogues – The capability within the NHS to co-ordinate
and pre-qualification. investment in procurement eEnablement
technologies.
NHS Procurement eEnablement – A transfer of skills and knowledge into NHS
Programme organisations to establish a mature understanding of
The NHS procurement eEnablement Programme (NPEP) is procurement eEnablement by NHS organisations.
about providing the NHS with the capability to effectively – To implement a once-only approach to the provision
use procurement eEnablement technologies and achieve of product and pre-qualification data.
the significant benefits that are available. The programme
implements the strategy Procurement eEnablement in the The NPEP projects were developed in consultation with a
NHS, June 2007. range of stakeholders from NHS organisations, suppliers
of goods and services and technology providers. The
At the core of the programme is the implementation of NHS Procurement eEnablement Programme is focused
common data standards for procurement and commercial on delivering pragmatic steps that put into place the key
processes. enablers required for the effective implementation of
procurement eEnablement technologies in the NHS and
The programme has four key outputs, described in Figure 3. drive forward the adoption of these technologies.

Figure 3: NHS Procurement eEnablement Programme

To provide a clear direction for the NHS, its suppliers and technology providers on the requirements
Direction for NHS procurement eEnablement. Through the provision of a strategy and then a model that
describes the capability requirements.
To put into place a strong awareness and understanding in the NHS of the benefits available from
Awareness and
procurement eEnablement, the current position of the NHS and the actions that are required to
Understanding
enable the significant benefits.
To establish NHS data and business message standards and requirements for interoperability between
NHS Standards
procurement eEnablement systems and provide guidance.

To significantly improve the capability of the NHS to effectively implement and utilise procurement
NHS Capability
eEnablement technologies.

24 2009/2010 GS1 Healthcare Reference Book

 The NHS Procurement eEnablement Programme –
Using information to deliver better healthcare

The level 1 projects are funded by the NHS Purchasing and Classification
Supply Agency and work on these commenced in mid The NHS standard for classification is NHS-
2008/09.The level 2 projects will be run over a three year eClass. This classification system is owned
period and require significant additional funding for which by the NHS and is mapped to several other
a business case has been presented to the Department of classification systems to ensure that NHS-
Health (October 2008). eClass can provide an effective analysis of
expenditure.
NHS Procurement data standards
The key building blocks of common data standards for NHS NHS Procurement eEnablement
commercial and procurement processes are coding systems Delivery Group
that enable the unique identification of suppliers and The NHS Procurement eEnablement Programme is owned
products and a classification system to enable the analysis of by the NHS Procurement eEnablement Delivery Group
expenditure. The NHS standards are: (NPEDG), the NHS stakeholder group for procurement
eEnablement, which was formed in late 2006. Membership
Supplier codes of NPEDG is drawn from organisations across the NHS and
Duns numbers from Dunn & Bradstreet are includes representatives from the home countries. The
the NHS standards for supplier codes. Duns current Chair of the group is Chris Slater, Head of Supplies
numbers are available free of charge for all from Leeds Teaching Hospitals NHS Trust.
legal entities. The NPEP programme has
provided a web portal to enable suppliers In June 2007 NPEDG published a strategy for procurement
and the NHS to identify Duns numbers. eEnablement in the NHS within ministerial sponsorship
and the NHS Procurement eEnablement Programme
Product and location codes implements this.
GS1 GTINs (Global Trade Item Numbers) are
the NHS standard for products and GLNs for For further information visit www.pasa.nhs.uk or contact
the identification of locations. [email protected].

ReferenceS

• Coding for Success – simple technology for safer patient care, Department of Health, February 2007
• Procurement eEnablement in the NHS, NHS Purchasing and Supply Agency, June 2007

Author

Rachel Hodson-Gibbons is a purchasing and supply Manager for medical equipment and working with the
professional and currently holds the post of Head of development of Collaborative Procurement Hubs for the NHS
eProcurement for the NHS Purchasing and Supply Agency Purchasing and Supply Agency.
in which she is leading the NHS Procurement eEnablement Rachel is a member of the Chartered Institute of Purchasing and
Program. Rachel's most recent posts have been Category Supply and holds an MSC in Procurement.

2009/2010 GS1 Healthcare Reference Book 25

U.K.

Integrating information flows in orthopaedics

at Leeds Teaching Hospitals NHS Trust

Abstract

The Leeds Teaching Hospitals NHS Trust’s demand management project has
produced significant efficiency savings in the orthopaedics supply chain. The
project highlighted the need for global synchronisation of product codes for
Article by Graham Medwell
automatic identification and data capture, including RFID within healthcare.

Background they are used, to ensure that the true cost of that procedure
Leeds Teaching Hospitals NHS Trust started to roll out is recorded accurately. In orthopaedics there is an additional
materials management in 1999 and now has over 270 requirement to record any implanted products and update
materially-managed stocking points. It has derived the National Joint Registry (NJR) for track-and-trace.
significant benefits from controlling stock levels in major
areas like Cardiology, where stock usage is updated live on The vision at Leeds is that the patient administration system
the system through barcode scanning at the point of use. and the stock systems are integrated to update stock
records and patient data automatically in order to improve
The Chapel Allerton Orthopaedic Centre (CHOC) was an accuracy and provide live data to suppliers and the trust
area identified in 2006 as a priority for increased stock budget holders. The data recorded would be invaluable in
management and as a stand-alone service for elective supporting activity-based costing.
surgery (orthopaedic trauma carried out at the Leeds
General Infirmary) which had a problem with high Data flows – the challenge
stock levels and system integrity problems arising from Within healthcare, unlike other sectors, there is a lack of
consignment stock and vendor-managed inventory. The consistency in the identification of product within the
system became known as “CHOC Stock“ and is now linked supply chain. It is for this reason that Leeds Teaching
to the main patient systems enabling product costing and Hospitals has been a major supporter of the DH in the
track and trace of product. implementation of GS1 standards. From our experience
in linking manufacturers’ bar codes to product within
The wider healthcare vision cardiology and radiology, we understood the scope of the
Patient safety was at the forefront of the DH paper ‘Coding problem in mapping thousands of codes within our systems.
for Success’ which featured ‘islands of application within the The suppliers of the products had no means of providing
NHS’ of Automatic Identification and Data Capture including the data, so we were left with the following alternatives:
the bar coding system implemented in the Leeds Teaching • Map the codes ourselves
Hospitals’ Catheter Labs. The report highlighted that around • Use our own bar codes
10% of NHS inpatient episodes result in errors of some kind
– of which 50% are preventable. Of 8 million admissions We decided to map the codes ourselves, but work with
each year, about 850,000 result in patient safety incidents the suppliers through GHX, the healthcare e-commerce
that cost the NHS £2billion in extra hospital days. exchange provider, to enrich the data used throughout the
supply chain. In September last year GHX announced that it
With the advent of payment by results, it is important that was to become a GDSN-certified data pool to accelerate use
consumables are recorded by each procedure for which of GS1 standards in healthcare.

26 2009/2010 GS1 Healthcare Reference Book

 Integrating information flows in orthopaedics
at Leeds Teaching Hospitals NHS Trust

Data Management catalogue management system that incorporates an online

The resources required to enable the introduction of an data repository containing catalogue information with secure
inventory control system should not be underestimated. The shared access for both providers and suppliers. It features
need to find, identify and record stock for over 2,500 product approved lists of centrally-managed product information
lines required a full team from the supplies department grouped by supplier, with customer specific pricing. Both
working over a public holiday in the elective area. (A later customers and suppliers can maintain the catalogue data.
trauma theatres project did not have the benefit of a
shutdown as they work 24/7.) SPaCE has involved Leeds and the suppliers Johnson &
Johnson and Covidien and even though the suppliers
ordinarily compete, SPaCE is bringing about an
unprecedented level of co-operation as all parties involved
– including members from the National e-Enablement
Group and GS1 User Group – see the potential benefits
in which they could all share. SPaCE aims to move
dispute management from end-of-process (invoicing)
to the beginning (demand management). As part of
this process, Leeds is involved in the synchronisation of
contracts through the GHX Nexus web-based interface.
The GHX Exchange is also being enhanced to handle more
documents, including the remittance advice and proof-of-
delivery and to share internal workflow with the supplier for
invoice reconciliation.

Although currently at the ‘proof of concept’ stage, the

resulting GHX Nexus project has already proved invaluable
in understanding the data flows within healthcare
purchasing and supply.

The challenge for orthopaedics

The orthopaedic supply model, where stock is held on
consignment at the hospital, was hugely inefficient, and
manufacturers are typically applying a 15-20% on-cost as
Labour Intensive – Supplies staff checks stock and a result. At Leeds, where the annual orthopaedic spend
allocates bar codes to products in orthopaedic
exceeds £3 million, the long-term reduction in consignment
theatres – May 2007. The CHOC Stock project
highlighted the need for global synchronisation of stocks has cut £500,000 from that figure.
product codes for automatic identification and data
capture within healthcare. Although joint replacement procedures have become routine
and are subject to long waiting lists, it remains difficult to
The Supplier Performance and forecast product demand accurately. The complex nature
Communications Enablement project of many procedures means that a vast range of sizes of
(SPaCE) prosthetic and ancillary products required (instrumentation,
Leeds was an early adopter of GHX’s e-commerce Exchange screws etc) is held on consignment in theatres.
and has been at the forefront of the search for even greater
accuracy and improvements in efficiency. In addition to the Clinical preference also meant that a number of suppliers
use of PowerGate Inventory in theatres and PowerGate Web were represented, with the result that costs and wastage
Requisitioning, the Trust has embarked on a programme rose. A team comprising the leading surgeons and
to improve catalogue management, for which it is using procurement staff agreed to standardise the range and as
GHX’s Nexus cataloguing solution. Nexus is a web-hosted a result new contracts were agreed with the suppliers. Data

2009/2010 GS1 Healthcare Reference Book 27

Integrating information flows in orthopaedics
at Leeds Teaching Hospitals NHS Trust

from the contracts was then enriched (classified, coded and actually used, the information on costs by procedure and
priced) and fed from the GHX Nexus catalogue system to implant data for the National Joint Registry can be recorded
the inventory system. in real time.

Stock management Data capture

The Leeds IT team worked hard to engineer the data process 1. Before the day of surgery patient records are sent from
so as to provide live and accurate updates to both stock PAS to CIS (demographics and patient history)
and patient systems. The solution is simple, as it mirrors 2. At reception PAS admission is entered and time of
the award winning processes successfully implemented in arrival; Galaxy time into department update; patient
cardiology and radiology at Leeds General Infirmary. The then gets changed and enters anaesthetic room; time in
inventory management system chosen was GHX PowerGate, anaesthetic room; time induced; Anaesthetic given; ASA
which was integrated into the Trust’s Oracle e-Business score all entered on Galaxy by theatre staff.
system alongside GHX Exchange for the electronic 3. Patient enters theatre – time recorded then time
transmission of order and invoice data and the GHX Nexus recorded knife-to-skin by theatre staff – also recorded is
catalogue management system. The area is connected to people in theatre and roles performed.
the Trust-wide Patient Administration system (PAS) and the 4. On completion closure time recorded; surgical outcome
theatre management system, Galaxy. recorded; time into recovery; time out of department
recorded.
All the stock that might be required for a procedure is • Knife-to-skin
taken to the theatre from the stock room by the clinician, • Closure
but the stock record is not updated. Once the stock is in • Out of department
theatre, the patient arrives and their ID is entered onto the These three updates trigger a message to CIS (clinical
patient administration system. From that point all scanned information system) which will now update PowerGate.
consumables used in the procedure are allocated to that 5. On CIS the information has created a theatre list,
patient and procedure type through PowerGate. It is only from which the surgeon can select patient and
when the next patient ID is entered that the scanner will input operation notes. (surgeon and anaesthetist
record product against the next ID. information) including procedure details and implants
used. Alongside CIS updates the consumables used are
Any unused stock is returned to the store (as it remains on recorded by theatre staff on to ‘CHOC stock’ – the Trust’s
the stock record) and from only scanning the stock that was nick-name for GHX’s PowerGate.

Pre assessment System Procedure System updates

Patient seen in clinic Stock received from

Supplier order received
and pre-assessed supplier

Procedure date agreed Patient date confirmed Patient surgery

Stock usage recorded/

Galaxy patient Patient entry recorded on
Patient admitted on scanned onto Powergate
administration system isoft Galaxy
Galaxy and Surgeon/ and order requirement
updated and consumable NJR entry allocated to
Anesthetist allocated assessed against stock
requirement recorded patient ID automatically
parameters

Several products taken to

Long term product Product requirement Product to be available theatre – only ones used
requirement available date confirmed (delivred day before) scanned – others returned to
storeroom

28 2009/2010 GS1 Healthcare Reference Book

 Integrating information flows in orthopaedics
at Leeds Teaching Hospitals NHS Trust

Actual or projected benefits Supply chain benefits

of the new system • Reduced stockholding for system stock
• Consignment stock on system, so order screens
Financial benefits reflect true position when determining replenishment
• Stock to the value of £400,000 was found over and requirement
above the consignment levels. This eased the pressure • Reduced obsolescence through stock visibility, stock
on the clinical area (in the year of introduction), which rotation and stock levels that ensure usage within expiry
had been seen as a failing area in terms of finance. • Reduced emergencies thanks to improvements in
Ongoing revenue benefits are being achieved by using forward demand/stock planning
quality inventory information to rationalise-down stock • Reduced cost of carriage as stock delivered on efficient
holding levels without the risk of stock outages. lead times and using scheduled deliveries.
• If the Trust could invest in reducing the consignment
stock, both the supplier and the Trust would reduce The vision for the orthopaedic centre
process and write-off costs. As a result, contract prices The vision for the orthopaedic centre is to automate all
could be reduced to share savings. information flows through the patient administration
• If consignment stock was only used for slow moving system, PowerGate stock control system and updates to
products (extremes of ranges) and new products with no the national joint registry database. To enable this, Leeds
demand patterns, then efficiencies would be maximised. Teaching Hospitals has data capture points (barcode
scanners) in the storeroom and in each orthopaedic theatre
Clinical benefits suite. The next stages are:
• Stock turnover increased, so any new products can be 1. orthopaedic kit RFID tagging proof-of-concept project
used quickly (no residual stocks to exhaust) and
• System stock integrity improved thereby improving 2. early demand capture.
stock availability
• All supplier relationships formalised, eliminating invoice Orthopaedic kit RFID - Proof of Concept
queries with clinicians Orthopaedic kits or modules, which contain hip and knee
• Supplier training, product development and new joints in a variety of sizes, are commonly utilised in the Trust.
product introduction still facilitated Although these kits simplify the sourcing of components
• National Joint Registry updated accurately and for a surgical procedure, they also complicate the
immediately administration process that supports it.
• Kit availability greater as a result of better forward
planning Each kit is loaned to the Trust on a consignment basis and
• Increased training quality as procedures and product only the elements that are utilised or not returned to the
requirements planned in advance. supplier are invoiced. This produces a manually-intensive
checking exercise at each point in the lifecycle of the kit.
Procurement benefits Before delivery, the supplier checks that all components are
• Increased notice for kits – opportunity to schedule present in the kit. The variety of kit complexity can mean that
procedures requiring same kit in sequence this is anything from a ten minute to a two hour process.
• All products to be part of a contract negotiation process, This checking is then repeated by the Trust on receipt of the
thereby ensuring best price kit from the supplier, as the absence of any component can
• Reduced supplier costs reflected in reduction of prices mean a cancelled operation. The checking is carried out again
to the Trust. after the surgical procedure, to ascertain which components
have been used and to record them manually for the creation
Supplier benefits of a purchase order that will match the supplier’s invoice. One
• Reduced consignment stock more check takes place on the return of any kit components
• Reduced need to manage stock levels to the Supplier as a final reconciliation.
• Reduced write-off of expired consignment stocks
• Increased information for forward demand planning.

2009/2010 GS1 Healthcare Reference Book 29

Integrating information flows in orthopaedics
at Leeds Teaching Hospitals NHS Trust

PowerGate allows the Trust to create a shopping list for each

What is a module? kit so orders can be generated by simple drag-and-drop-
An inventory code with a bill style requisitioning.
of materials below. e.g 5421
Each module has a build/lot These requisitions are then matched with Oracle Purchasing,
number. E.g 5421/6
where they produce purchase orders which are then
Each item in the build has transmitted via GHX’s e-trading exchange and routed via
product and lot number.
GHX to the supplier.
Johnson & Johnson are
committed world-wide to
The outcome of implementing these technologies is that:-
implementing GS1 standards
and these will form the basis 1. Orthopaedic kits become their own receipts, while
of future RFID projects within issues and returns are recorded in the inventory solution
Leeds. The timescales for the without the need for manual intervention
J&J adoption of GS1 standards
will vary by J&J business unit. 2. Consumed components create receipts against the
purchase order which then act as a complete three-way
Orthopaedic kits or modules, which contain hip and match control for invoicing
knee joints in a variety of sizes, are commonly utilised
by the Trust. 3. Clinical staff are able to check the contents of a kit
instantly, without the need for manual counts at each
step in the administrative and clinical process
Radio Frequency IDentification (RFID) is potentially a perfect 4. The Trust can meet legislative prompt payment
remedy to all of these manual checks. Leeds Teaching requirements for invoices which otherwise would be
Hospitals, in conjunction with GS1, Depuy, Sybase and GHX, delayed, due to the reconciliations required
have piloted a test case of RFID-tagging a kit to simplify 5. Supplier stock-to-cash cycle is improved.
ad-hoc checking, receipting, issuing and final return of
orthopaedic kits. The technology is scalable and the concept has been
proven but we now need a full pilot to prove the concept
The solution has been built around Sybase’s RFID Anywhere within the wider healthcare orthopaedic arena.
software. The advantage of this three-tier solution is
that it translates inputs from a variety of sources into an Early demand capture
homogenous message type which is then filtered for This area is in the next phase of development at Leeds.
relevance. Filtered messages may then pass onto the business The patient is assessed several weeks before the procedure
layer. This approach means that a number of input sources takes place (normally 6 weeks). At this point the surgeon,
can easily sit alongside each other and should the initial RFID given demographic characteristics and procedure type, can
tags / readers change then the effects are insulated from predict with a degree of accuracy the product requirement
the rest of the solution. The variety of built-in adaptors to (through a lookup template). The early demand information
communicate to ERP systems also means that the business should help suppliers to optimise production, resulting in
layer is easily portable should their corporate solution(s) improved service efficiency and performance. The forward
change and the solution can again be easily ported to other demand could also help the trust to ensure that any kits
organisations with entirely different ERP solutions. required are used for sequential procedures and so reduce
rental costs.
Leeds Teaching Hospitals integrated the solution into GHX’s
PowerGate inventory management system, which is in turn The first phase of the implementation has been successful
deeply integrated with Oracle Applications Purchasing, the and Leeds now automatically updates patient records
Trust’s corporate ERP system. and joint registry information in the theatre environment
through scanning equipment.

30 2009/2010 GS1 Healthcare Reference Book

 Integrating information flows in orthopaedics
at Leeds Teaching Hospitals NHS Trust

New process flow

Patient ID Procedure takes place Patient leaves theatre

The day prior
to surgery Patient arrives in entered onto
PAS Time of theatre entry, knife- Surgical outcome recorded, Once a new
patient orthopaedic centre
(isoft Galaxy) to-skin and people present patient recorded out-of- patient ID is
records are
recorded on CIS theatre entered the
sent from PAS
to CIS Type of All consumables used are scanning is
procedure, scanned in theatre into completed for
Patient All products potentially arrival time Unused products not the previous
PowerGate and allocated
history and to be used are issued to and ‘into- scanned and returned to procedure
to the procedure code for
demographics theatre department’ stock
costing and to the patient
recorded time ID for the NJR

Note
PowerGate Locally known as CHOCSTOCK – is the stock
Output from PAS to CIS and PowerGate
control and forecasting system
Knife-to-skin time
CIS Clinical Information system
Closure time
PAS Patient Administration System (isoft Galaxy)
Out-of-department time

Possible future process flow

The day prior Procedure takes place Patient leaves theatre
to surgery
Patient arrives in
patient Time of theatre entry, knife Surgical outcome recorded,
orthopaedic centre Patient ID
records are to skin and people present patient recorded out-of-
entered onto recorded on CIS theatre
sent from PAS
PAS Once a new
to CIS
(isoft Galaxy) patient ID is
Patient entered the
history and Type of All consumables used are scanning is
demographics procedure, scanned into the Galaxy completed for
recorded All products potentially arrival time Unused products not the previous
‘equipment module’ –
to be used are issued to and ‘into- scanned and returned to procedure
Information implants used recorded
theatre department stock
shared with and consumable usage
‘time updated to PowerGate
suppliers for
production
planning

Output from PAS to CIS and PowerGate

Knife-to-skin time
Closure time
Out-of-department time
NJR data
Implants and consumables used

Managing the transition

Step 1 – Agree Step 2 – Training Step 3 - Procedures Step 4 – Stakeholder Step 5 – System
stock levels All staff taken to see To ensure the new engagement transition
Clinical and supplies staff the barcode recording system is as efficient as All stakeholders engaged After 6 months the
agree practical minimum system working in other possible and benefits in stock level review order history is on the
stock levels, reorder departments (cardiology) are maximised, the proc- and the importance/ system and the ordering
levels and consignment and at other trusts. esses are recorded and benefits of recording all function is transferred
levels monitored products used commu- to predictive order-
nicated. Cross-functional ing – significant service
group set up to review improvement.
quarterly and agree new
product lines

Author

Graham Medwell is the Business manager for the Leeds as working on health event linkage for the local health authority.
Teaching Hospitals NHS Trust, with sixteen years experience in He is a member of the GS1 UK HUG and the NHS National
developing purchasing systems within the public sector as well e-Enablement Programme.

2009/2010 GS1 Healthcare Reference Book 31

Japan

RFID and barcode based management of surgical

instruments in a theatre sterile supply unit

Abstract

To effectively use surgical instruments Kanto Medical Centre NTT EC in

Tokyo has introduced automatic identification and data capture (AIDC)
technologies in the Theatre sterile supply unit. Both two-dimensional
Article by Dr. Chikayuki Ochiai
barcode (DataMatrix, 3~5mm square in size) and RFID tag are used for
verification of surgical instruments and their containers, respectively.
Although statistically meaningful data has not yet been drawn,
effectiveness of AIDC technologies has already been well recognized
among the staff in the operating room (OR) because accuracy and
fluency of the sterile and supply unit (SSU) after the introduction of AIDC
technologies are apparently improving.

Introduction if a surgical procedure is the same, common surgical

Kanto Medical Centre NTT EC (Nippon Telegraph and instruments and materials should be used regardless of
Telephone East Corporation) is located in the south of surgeons. Standardisation of surgical procedure is essential
Tokyo. It was remodelled at the end of 2000 as a 606-bed not only for simplifying workflow in the Sterile Supply Unit
general hospital fully, equipped with modern information (SSU) but also for saving cost in the OR. Outsourcing is very
communication technologies (ICT) including an electronic effective as proven in all aspects of hospital management.
medical record (EMR) system. Barcode scanning for Freeing surgical nurses from such tasks as cleaning
verification of patient identity via a wrist band was also operating rooms and washing surgical instruments enables
introduced in 2008. The hospital treats 2,300 outpatients them to play their own roles in their original field.
daily and more than 15,000 admissions annually. Surgical
case volume is reaching 6,000 a year. Where outsourcing of tasks has taken place, outsourced staff,
who work in the SSU, are often not familiar with the tasks.
In order to overcome a shortage of operating rooms Declining efficiency in the SSU due to outsourcing might
caused by unexpected increase of surgery, we have started affect the entire efficacy of the OR. Process improvements in
to implement AIDC technologies in the Theatre sterile the following areas in the SSU were mandatory:
supply unit. We report here how we utilise radio frequency • Simplification of tasks
identification (RFID) and barcode for maximising the • Standardisation of workflow
operating room facility (OR). • Improvement of safety and reliability
• Traceability of instruments (Frequency of use,
Process improvement in the sterilisation, repair, storage, event history etc.)
Sterile Surgical Unit (SSU) • Reduction of sets
Standardisation of surgical procedure and outsourcing of
non-specific tasks of medical staff are essential issues for Workflow of the SSU forms a loop composed of retrieve, sort,
increasing efficiency of the OR. In the past, most surgeons washing/decontamination, assembly, sterilisation, supply
used to require their own surgical instruments and materials and storage. These processes, instruments going back and
for performing surgery in their own way. Today, however, forth between OR and SSU, are very suitable situations

32 2009/2010 GS1 Healthcare Reference Book

 RFID and barcode based management of surgical instruments
in a theatre sterile supply unit

Figure 1
for applying AIDC technologies; data capture can provide
information as follows: Data
• When the surgery started and ended Matrix
• When and by whom instruments were retrieved and
washed
• Which instruments are in each container
• How often instruments are being used
• When and which instruments have been repaired
• When, how and by whom the container were set,
sterilized and stored
• Which patient the instruments were used upon (AIDS,
Creutzfeldt-Jakob disease, etc)
UDI for Metal
instruments
Not only simplification of the task but also recording of event
history will become possible with using barcodes and RFID. Scanner

Introducing Unique Device Direct part marking to each instrument was carried out on
Identification and Traceability its flat mirror–like surface by laser printing in cooperation
As a unique device identification (UDI) for metal instruments with Mizuho Ika Kogyo Co. Ltd. Durability of barcode
we have employed DataMatrix, two-dimensional bar code, printing to rust and friction had already been proven
3~5mm square in size, according to the guideline of JAMEI through five-year tests. Reversed reading was chosen for
(Japan Association of Medical Equipment Industries). increased legibility of barcodes.

Figure 2: Theatre sterile supply unit in Kanto Medical Center NTT EC

RFID reader RFID reader

for retrieve Office High pressure for supply
PC
steam sterilization

EV EV

Retrieve Sterilization Supply

Assortment
Washing Washer disinfector RFID reader
for sterilization

Decontamination Assembly

EOG sterilization

RFID reader Bar code RFID reader Shelf

for assembly reader
Containder carrier Table

2009/2010 GS1 Healthcare Reference Book 33

RFID and barcode based management of surgical instruments
in a theatre sterile supply unit

Instruments are grouped together into a set by surgical • Two at the exit of high pressure steam sterilizer
procedure and housed in a container. For identifying the
container an RFID tag was applied to it.

In Kanto Medical Center NTT EC the OR is located on the

third floor and the SSU on the B2 floor. Both floors are
connected with two elevators (EV) specific for surgical
instruments. Automated guided vehicles carry used
instruments in their containers to the entrance of the SSU.
RFID
RFID tags antenna

RFID tag
Multiple containers are put into the sterilizer with the
tagged face directed left. When sterilisation is completed
and the containers are pulled out from the opposite
side, tags are simultaneously recognised by the antenna
at the exit. Data relating to sterilisation are recorded,
namely which sterilizer was used, when sterilisation
started and ended, completeness of process, name of
RFID antenna the set and method of sterilisation.
• One at the exit of the SSU
Finally containers are sent to the OR via EV for storage.
After here, used instruments proceed along the arrows The RFID antenna set here collects date of supply and
shown in figure 2. name of the set.

A total of five RFID antennas are in place in the SSU:

• One at the entrance of the SSU
Retrieval of multiple containers is simultaneously verified
while they are passing in front of the antenna. Name
of the set, which department used it and when it was
retrieved are automatically recorded. scanner

• One on the table for assembly

Following the process of washing/decontamination via

RFID
antenna washer disinfector instruments are sent for assembly, where
a barcode reader is installed to support tasks of assembly.
Staff are requested to hold each instrument over the barcode
reader before grouping it together into a set. A green light
on the display indicates the instrument belongs correctly to
RFID tag
that set. If a red lights appears this indicates the instrument
is in the wrong set. Staff not familiar with assembly, while
After housing a set in the container the tag on it is read holding the instrument over the bar code reader, can refer
to record name of the set and time when assembly was to the name of the instrument and its photograph displayed
accomplished. on screen. The display also shows the number of individual

34 2009/2010 GS1 Healthcare Reference Book

 RFID and barcode based management of surgical instruments
in a theatre sterile supply unit

instruments that comprise the set. During this process if Conclusion

an instrument that needs to be repaired is found, it can be We have not yet obtained enough data. However, every staff
replaced with a new one. member in the SSU believes that workflow of assembly has
become simple and accurate.

At present, we have accomplished barcode printing on

approximately 6,800 instruments. In 141 out of 208 sets an
RFID tag has been installed on their containers. Printing
on 8,000 instruments is the goal. Recently, printing on
both sides of the instrument has been started to make
barcode reading more convenient. Direct part marking to
each instrument, however, is too costly for end users to do
themselves. To increase the utilization of AIDC technology
in OR and SSU, globally standardized UDI, such as GS1
DataMatrix barcode, should be marked on every product
by the manufacturer. If such an identification system
for instruments is built, in the near future, all sorting and
We started the introduction of barcode and RFID in April distribution of surgical instruments and sets could be
2008. Management error of surgical instruments relating done automatically and more accurately using a robotic
to the SSU occurred in 108 out of 5,712 surgical cases distributor, avoiding human error and saving manpower.
(1.89%) from April 2007 to March 2008. 58 errors were in Similar problems occur in the field of medication
assembly (53.7%), 13 in retrieve (12.0%), 13 in washing/ administration.
decontamination (12.0%), 10 in supply (9.3%) and 4 in
storage (3.7%), with the remainder in other areas. Among If AIDC technologies are applied to everything used, spent
the 58 assembly errors one third of them was due to poor and wasted in the hospital, we will be able to track forward
inspection and one fifth of them due to lack of devices. and trace back every care and every event for each patient
During the first four months from April to July 2008, we as a link to records, composed of 5W1H, along the time line
experienced 31 errors among 1,913 cases (1.62%). However, from his/her admission to discharge. It should ultimately
only three errors occurred among 2,729 surgical cases assure patient safety and enable cost management in the
(0.11%) from August 2008 to January 2009. Regular use field of health care.
of barcode and RFID possibly decreased the errors during
these six months.

Reference

MIZUHO IKAKOGYO CO., LTD, 30-13, Hongo 3-Chome, Bunkyo-Ku, Tokyo, 113-0033, JAPAN, http://www.mizuho.co.jp

Author

Dr. Chikayuki Ochiai, M.D., D.M.Sc is the Chief Executive of neurosurgery in Dokkyo University School of Medicine, as head
Kanto Medical Center NTT, Tokyo. After graduating from the of neurosurgery in JR Tokyo General Hospital, and as head of
University of Tokyo, Faculty of Medicine in 1971 he majored in Neurosurgery in Kanto Teishin Hospital (present Kanto Medical
neurosurgery. Before being promoted to his current position in Center NTT EC). He experienced more than two thousand
2002, he held various posts including a professor of neurosurgery surgical cases in his career as a neurological surgeon.
in the University of Tokyo Hospital, as assistant professor of

2009/2010 GS1 Healthcare Reference Book 35

U.S.A.

BPOC/eMAR spotlight
on performance improvement

Abstract

The implementation of an electronic medication administration record

(eMAR) and utilization barcode point of care technology (BPOC) in the
medication administration process can dramatically improve patient
Article by Noel Hodges
safety and prevent the wrong medication from being administered to
a patient. While the realization of this technology in our health-system
has prevented countless medication errors, we continue to experience
errors that should be prevented by using BPOC. This article outlines
how we have trended medication errors and developed performance
improvement activities to improve patient safety following the
implementation of BPOC.

Implementing eMAR at HCA organization wanted to create a more complete electronic

In early 2002, the Hospital Corporation of America (HCA) documentation system without compromising the function-
began a pilot to implement an electronic medication admin- ality of the existing paper MAR. Today our eMAR is being used
istration record (eMAR) and to utilize barcode point of care to display the patient’s current active medication list; and a
technology (BPOC) for medication administration in approxi- bar-coded, unit-of-use medication is scanned prior to admin-
mately 171 of their acute care hospitals in the United States. istration to the patient (BPOC).

In 2003, HCA started this initiative in their Richmond Market, HCA’s longstanding relationship with Medical Information
consisting of six acute care hospitals supporting 1620 operat- Technology, Inc. (MediTech), their hospital information
ing beds in Richmond, Virginia (USA). A major reason for system, made implementing their eMAR and BPOC system
implementing eMAR was to enable the healthcare provider extremely easy. The system integration allowed nursing and
to administer medications with confirmation of the Five pharmacy to communicate in real time and improve patient
Rights of medication administration: right patient, right dose, safety. The systems also provided data and information that
right route, right time, and right medication. Secondarily, the was never captured before, including medication errors.

Figure1: 2006 Medication Events by Event Code

0 200 400 600 800 1000 1200 1400 1600

Dose omission
Improper dose
Wrong medication
Wrong time
Wrong duration
Wrong strenght/concentration
Wrong patient

36 2009/2010 GS1 Healthcare Reference Book

 BPOC/eMAR spotlight
on performance improvement

Figure 2: HCA’s Patient Safety Goals

• Establish patient safety and a visible commitment

to “putting patient first” philosophy
• Move from blaming people to improving
processes
• Improve use of technology to prevent and
detect error
• Use data to identify and measure improvements

Post eMAR Implementation: Reporting and

Monitoring of Medication Events
To improve patient safety utilizing eMAR and BPOC within the
hospital environment, medication errors must be identified,
reported, reviewed and properly categorized. Only after each
of these steps has taken place, can the data be analyzed and
used to develop a performance improvement process. The
purpose of this project was to provide hospitals a standard
taxonomy that could be used in classifying the specific cause
of each medication error reported. This standardization would
assemble data that could trend specific error causes within a
In 2007, medication event data began to be reviewed health system and present opportunities for improving the
from our 2006 data in aggregate from each of our facilities. medication use process.
Notability, we were still experiencing “wrong patient” and
“wrong medication” events (Figure 1). It was our original Within our health-system, the medication error reporting
hope that by using eMAR and BPOC, which required every tool in MediTech was modified to include a standard
patient and every dose to be scanned, that wrong patient taxonomy for documenting the specific cause of each
and wrong medication errors would become never-events. medication error. This taxonomy focused on event
codes, such as wrong patient or wrong medication, it
Within our health-system, our average patient scan rate then further classified errors by a general cause such as
was 96.58% and our average medication scan rate was communication or staff competency. The final stratification
96.10%. Based on 11,862, 865 doses administered in was identifying the specific cause, like illegible handwriting
2006, approximately 462,000 doses were given outside or or miscalculation of dose. Our taxonomy was adapted
bypassed our system checks. These startling discoveries from The National Coordinating Council for Medication
lead us back to HCA’s original patient safety goals (Figure2). Error Reporting and Prevention (NCC MERP)1 and modified
We needed to use the data that was collected to improve to include specific cause codes relative to BPOC such as
our medication administration process and enhance our “medication barcode will not scan”, “patient armband will
technology to make it easy to do the right thing and harder not scan”, “wrong medication packaged or bar-coded”…etc.
to do the wrong thing. These specially created cause codes gave us the ability to
track and trend medication errors related to our bed-side
Medication doses given without using BPOC demonstrated technology.
a gap in our process that resulted in a greater opportunity
for a potential error. In addition, we also experience A multidisciplinary team of pharmacy directors, risk
medication events when the system was used as designed managers, and quality management staff reviewed the
or partially used. We recognized our focus must be on
tracking and trending both of these variations. 1 http://www.nccmerp.org/pdf/taxo2001-07-31.pdf

2009/2010 GS1 Healthcare Reference Book 37

BPOC/eMAR spotlight
on performance improvement

Figure 3

Communicate between clinicians

Communication between clinicia

Equip programmed/setup wrong
Pharmacy central order entry
Miscalculation of dose/rate

Chart check per hosp policy

Competency/not trained
ACK incorrect/omitted

Illegible handwriting
Duties not performed
Order interpretation
EvCode
Order entry error

P&P not followed

Prescribing error
Dispensing error

Order execution
Order missed

Inattention

Other
Improper dose 185 115 47 15 19 21 20 17 18 19 17 17 16 18 14 9 8 8 10

Wrong dose form 31 14 3 9 2 2 2 3 1 1 1 2 2 4 1 2 1

Wrong strenght/
50 27 7 19 7 3 3 4 2 2 3 3 2 1 2 3 2
concentration
Grand total 266 156 57 43 28 26 25 24 21 21 21 21 20 19 16 15 12 12 11

specific causes assigned to each general cause. Once the list reporting and categorizing medication errors. This team
was finalized, staff education was done to ensure the coded also provided leadership for medication error reduction
of errors was consistent in each facility. A recommended and process change, monitor data integrity, interpret data
team of pharmacy, nursing, risk and quality professionals with trending analysis, and identify systems breakdown. This
within each facility was charged with reviewing each error group focused on performance improvement activities that
and applying the correct error cause codes. This process was could be implemented in our hospitals to prevent future
done weekly in many of our facilities to ensure medication medication errors.
events were analyzed in a timely manor.
Post eMAR Implementation: Performance
Error tracking based on specific cause codes was provided Improvement Activities
to each facility on a monthly basis while trends throughout By analyzing our medication event data and through direct
the health system were reviewed and performance observation of the medication administration process we
improvement processes were implemented. By using this have identified several key areas for performance improve-
taxonomy medication errors can be tracked and trended ment: only medications with viable barcodes reach the
within each institution and provide a system-wide approach patient, all medication should be scanned before administra-
to establishing safe medication practices in all facilities. For tion, and scanning all pills required for a complete dose.
example in Figure 3, we found the most common cause or a
patient to receive the wrong dose of medication (improper It was imperative as part of the pharmacy process to ensure
dose, wrong form, or wrong strength / concentration) was each unit-dose or unit-of-use medication reach the patient
due to pharmacist order entry errors. But we also found with a viable bar-code. During the drug procurement
mathematical calculations, physician prescribing and process, our pharmacies tried to source only bar-coded
communications also contributed to these types of errors. medications. This strategy was supported by our contracting
department in selecting pharmaceutical manufactures
At a corporate level, a small team of pharmacy, quality that bar-coded their products. Our purchasing process
and nursing professionals then developed training tools required the scanning every medication received in our
and system changes to assist individuals at each facility on pharmacies. For those medications without bar-codes or

38 2009/2010 GS1 Healthcare Reference Book

 BPOC/eMAR spotlight
on performance improvement

those medications where the bar-codes would not scan, package was scanned twice to complete the administration
pharmacy would quarantine those products until a bar-code of this order. In both of these cases where only part of the
could be applied. dose was scanned, patient safety checks are bypassed.

During direct observation many medications were either These and other “short-cuts” or “work-a-rounds” start with the
not scanned or scanned after the medication administration pharmacy ensuring proper, viable bar-codes. This important
process. Several factors contributed to these work-a- rounds, quality assurance process begins in the pharmacy and must
but on of the most common reasons given by nursing staff be done for every medication procured and ultimately
was the reliability of the medication bar-codes. If an individual dispensed for patient administration.
medication package failed to scan correctly, the nurse was
required to wait for the pharmacy to resolve the issue or Conclusion
replace the package. We found some nurses would save an In conclusion BPOC is one of the most important
empty package they knew would scan as a back-up and technologies we can use in our hospitals to improve patient
therefore not having to wait for pharmacy to resolve the error. safety. Bar-code technology is used in virtually every industry
and for multiple applications. Health-care must implement
Many of our medications require multiple tablets to equal the and maximize the patient safety benefits from BPOC.
prescribed dosage. For example, an order for acetaminophen
650mg required two 325mg tablets. We experienced
incidents where only one table was scanned or the same

Author

Noel Hodges is a licensed pharmacist in the Commonwealth provides continuous monitoring of bedside scanning
of Virginia. As the Director of Pharmacy Services for HCA compliance and patient safety. He was also responsible for
Central Atlantic Supply Chain, he is responsible for facility developing a centralized bar-code packing operation for
supply chain pharmacy operations and to identify and his health-system. He has authored multiple articles and
execute continuous improvement opportunities. Hodges presented posters at American Society of Health-System
completed his pharmacy degree at Purdue University and Pharmacists meetings and The National Patient Safety
his Master of Business Administration from Strayer University. Foundation on the topic of eMAR and BPOC. He has spoken
Hodges led the pharmacy implementation of Electronic locally, nationally and inter-nationally on bed-side scanning
Medication Administration Records (eMAR) and Bed-side system, drug packaging, and BPOC.
Point of Care (BPOC) for the HCA Richmond Division, and

2009/2010 GS1 Healthcare Reference Book 39

Australia

eCommerce within the hospital

pharmaceutical supply chain lays foundation
for improved patient safety

Abstract

The Monash Pharmacy project, a phased project with participants

representing healthcare manufacturers and wholesalers, hospital
pharmacy and tertiary education institutions, aimed to set the standards
for eCommerce and supply chain management in the healthcare and
pharmaceutical industries in Australia. Phase One, completed in mid-
2004, demonstrated that the GS1 System could deliver benefits when
implemented within the hospital pharmaceutical supply chain. This
phase incorporated the use of EANCOM-format electronic purchase
orders, purchase order acknowledgements and dispatch advice messages
between suppliers and the hospital pharmacy of a major Australian Article by Nigel Allsop,
hospital. Phase Two commenced in mid-2005 and involved broader Ged Halstead, Anthony Keyes
implementation of the processes used during the first phase to additional and Ian Larmour
suppliers as well as to all hospitals in the Southern Health network. In
addition, the scope was expanded to include a data synchronisation pilot
via the National Product Catalogue (NPC). Phase Three commenced in
mid-2008 and will broaden the project scope further.

Background and large enterprises: Clifford Hallam Pharmaceuticals,

The supply of pharmaceuticals and other goods to Hospital Supplies of Australia and Orion Laboratories as well
Australian hospitals is complex due to the mix of state, as key stakeholders including Health Purchasing Victoria
federal and private interests as well as a plethora of (an independent statutory authority for the procurement of
regulatory requirements. Yet while other Australian industry services, equipment and goods for Victorian public hospitals
sectors, such as retail, have gained irrefutable benefits and other health agencies), National Supply Chain Reform
through the use of electronic commerce, the supply of Task Force (NSCRTF), Pharmhos Software and the project
healthcare products has remained predominantly paper- managers, EAN Australia (now GS1 Australia).
based with manual processing.
The GS1 System
In 2003, seeing an opportunity to introduce greater At the heart of an effective electronic commerce system is
efficiency in their supply chain, a group of proactive and a global way to identify trade items and logistic units: the
leading health sector companies banded together to GS1 System of global standards. To gain unilateral support
participate in a project to demonstrate the use of electronic across the Australian pharmaceutical/healthcare sector for
commerce in a tightly defined but manageable project, the ‘one standard’ identification system, the Monash Pharmacy
Monash Pharmacy Project. The pharmacy department of Project team needed to illustrate the benefits to all
a major Melbourne hospital, the Monash Medical Centre, industry suppliers.
chose to work with suppliers, representing small, medium

40 2009/2010 GS1 Healthcare Reference Book

 eCommerce within the hospital pharmaceutical supply
chain lays foundation for improved patient safety

The premise of the GS1 System is that by introducing or created using the GS1 company prefix of the issuing
standards to key aspects of supply chain identification and GS1 member company, to identify physical, functional and
communication, organisations can more easily implement legal entities during electronic messaging exchanges. GS1
best-practice processes because all trading partners will identifiers provide trading partners with an accurate and
understand the standards used and not request proprietary abbreviated means of referencing entities, trade items, and
solutions. Everyone speaks the same language when logistics units in their databases.
standards are used. This project used GS1 Standards for
identification, electronic messaging, bar coding and data GS1 EANCOM provides a standardised and predictable
synchronisation. structure for electronic business messages, enabling
business partners to communicate business data rapidly,
The GS1 System identifies trade items using Global Trade efficiently and accurately, irrespective of their internal
Item Numbers (GTINs). These are internationally unique, hardware or software. As a subset of the UN/EDIFACT
non-significant numbers assigned by GS1 members (who standard (United Nations Electronic Data Interchange for
are product brand owners) using their GS1 company prefix. Administration, Commerce and Transport), GS1 EANCOM
Each different variant of an item and packaging level is provides for the collection of the message elements
identified by a different GTIN. needed by business applications and required by the syntax
(mandatory elements). GS1 EANCOM also incorporates the
Logistics units are identified using Serial Shipping Container GS1 standards for the identification of trade items, logistics
Codes (SSCCs). These globally unique identifiers are issued units and trading partners which allows for the integration of
by the creator of the logistics unit, using their GS1 company the physical flow of goods with related information sent by
prefix. Global Location Numbers (GLNs) are issued by GS1 electronic means.

2009/2010 GS1 Healthcare Reference Book 41

eCommerce within the hospital pharmaceutical supply
chain lays foundation for improved patient safety

Phase 1 Myers Squibb, Hospira Australia, Novartis Australia, Orion

Phase 1 of the Monash Pharmacy Project, completed in mid- Laboratories and Pfizer Australia), two wholesalers (CH2
2004, was a demonstration of electronic messaging using and Symbion Hospital Services) and the Southern Health
the GS1 System in the hospital pharmaceutical supply chain. Pharmacy Department, operating from five hospitals,
participated in Phase 2. Others involved included Monash
During Phase 1, the ability to send or receive (as appropriate) University, Health Purchasing Victoria, and GS1 Australia.
standards-compliant purchase orders, purchase order
acknowledgements, and receive despatch advices was Three areas of implementation of the GS1 System were
put in place by both the Southern Health pharmacy and identified for the Phase 2 project scope. These related to the
suppliers. SSCCs were placed on the logistics units being project objectives outlined above and were driven by the
supplied to the pharmacy and a project was undertaken learnings from the Phase 1 demonstration:
to study the process and requirements for bar coding • Identification and bar coding of trade items
pharmaceutical items. • Electronic messaging (using GS1 EANCOM) and
improving order fulfilment accuracy
Phase 1 successfully proved the application of the GS1 • A pilot of data sychronisation via the National Product
System of identification, bar coding and electronic Catalogue (aligning with the objectives of National
messaging in the areas of hospital pharmaceutical ordering, E-Health Transition Authority or NeHTA1)
picking, packing, despatch and receipt of goods.
For data synchronisation between trading partners the
The outcomes of Phase 1 established that improved trading project piloted GS1net, the Australasian data pool service for
efficiencies and cost savings could be achieved by the the synchronisation of item, price and industry specific data
healthcare industry through the use of electronic messaging between buyers and suppliers. This simultaneously provides
and improved supply chain processes underpinned by the all trading partners with accurate and consistent item data.
use of the GS1 System. Compliant with the Global Data Synchronisation Network
(GDSN), GS1net minimises data errors by eliminating human
The immediate benefits included a reduction in stock receipt intervention and the need to maintain multiple catalogues.
time at the hospital pharmacy of 25 per cent, improved
accuracy in order fulfilment accuracy of about 50 per cent, The NPC is hosted on GS1net, allowing for supply chain and
and an embracing of the new processes and technologies healthcare industry specific data to be exchanged.
by staff. In addition, a number of key issues were identified
which needed further investigation, including: Participant organisations selected their scope from the three
• The allocation of GS1 Global Trade Item Numbers (GTINs) project options, in line with their organisation’s business
and bar coding at a higher level goals, objectives and short-term capabilities. As the project
• Packaging (inner and shipper/carton level) proceeded and participants understood the benefits of their
• Future requirements for batch/expiry date tracking chosen project implementations, some began to introduce
• The need for broader adoption of supply chain standards aspects of this with other trading partners outside of those
• The need for data quality to be maintained continuously originally selected.
through master data synchronisation
Quantitative Key Performance Indicators (KPIs) were defined
Primarily, the first phase of the project provided the for each of the possible sub-projects. In addition to these,
incentive and confidence to undertake Phase 2. structured interviews were conducted with key project par-
ticipants to ensure anecdotal, qualitative data was captured.
Phase 2
Phase 2 of the project furthered the Phase 1 concept, by Key outcomes from Phase 2 of the project included:
broadening both the project team and the implementation • Scanning Serial Shipping Container Codes (SSCCs) and
scope, whilst focussing on ease of implementation and matching these with the electronic Despatch Advice
further roll out of the standards. Seven pharmaceutical
manufacturers (Abbott Australasia, Baxter Healthcare, Bristol
1 NEHTA was established by Australian Health Ministers to develop national
eHealth standards and infrastructure requirements.

42 2009/2010 GS1 Healthcare Reference Book

 eCommerce within the hospital pharmaceutical supply
chain lays foundation for improved patient safety

resulted in a quantitative reduction of 60 to 92 per cent Looking forward

in time taken to receive stock into the Southern Health The Monash Pharmacy project is an excellent example of in-
pharmacy system dustry collaboration driving supply chain reform. What started
• The Southern Health purchasing staff recognised as a small demonstration project, involving four trading
that the benefits are increasing as more companies partners, has grown to include representation from more than
implement standards-based electronic messaging a dozen organisations throughout the healthcare industry.
• Implementation of the project electronic messaging
methodology beyond the current project team – to Moving forward, the objective is to use the project to
other customers and suppliers – was undertaken by a further refine and improve supply chain efficiency within
number of participating organisations the industry. The next phase will look to broaden the scope
• Varying degrees of data discrepancy were reported as of customer participation across Victoria to develop a more
part of the GS1net pilot. This involved comparison of comprehensive scope of activity for supply chain reform. This
Baxter NPC to Southern Health Pharmacy system data: could be used as input for the next Victorian pharmaceutical
trade item description and label name (100 per cent tender, which will also focus on supply chain performance.
discrepancy), brand (92 per cent), Baxter internal code The Monash project would then be an avenue to work with
(29 per cent), selling unit of measure (73 per cent) and proactive partners to implement these supply chain reform
classification (15 per cent) highlighting the need for activities and demonstrate the value that an efficient supply
data synchronisation via the NPC in healthcare. This chain can bring to all stakeholders. This collaboration between
pilot was the first instance in which healthcare data was stakeholders will also encompass opportunities for the Victo-
exchanged on GS1net, a GDSN-compliant platform rian implementation of the National Product Catalogue.
• Anecdotal reports from the project team indicated that
working in a collaborative environment mean imple- It is important to remember that all of the foundations
mentation timeframes for electronic messaging could be being laid throughout the Monash Pharmacy Project are
reduced from 2–3 months to 2–3 weeks due to sharing of the foundations for the ultimate healthcare goal – improved
learnings – a significant saving of time and money patient safety.
• A number of project learnings were documented for
sharing with the broader industry

AuthorS

Nigel Allsop is Manager, Strategic Procurement, Health Service Institute of Australia and in 2008 the Customer Support
Purchasing Victoria. Nigel brings over 17 years experience to HPV team won the Baxter Global Supply Chain Award. Anthony is
covering such diverse areas as supplier management, strategic a licensed customs broker and holds a number of business
procurement, inventory management, E-procurement and qualifications.
process improvement across commodities and services. Nigel has Ian Larmour has been a Director of Pharmacy, at a number of
achieved qualifications in Masters of Business, Bachelor of Arts major hospitals, since 1981. Currently he holds the position of
with Honors in Business Studies, after successfully completing a Director of Pharmacy for the Southern Health group of hospitals
trade apprenticeship as an Electrician. in Melbourne. Ian is a member of the Melbourne Teaching
Ged Halstead is the Chief Information Officer for CH2. Hospital Drug Usage Group (now called Victorian Therapeutic
See page 18. Advisory Group) and was Chairman from 1993 until 1995. Since
Anthony Keyes is Customer Support Manager, Australia and 2000, Ian has been a member of the Victorian Ministry of Health
New Zealand, Baxter Healthcare. Anthony has over 30 years Poisons Advisory Committee. Over the years Ian has been
experience in the healthcare industry. Anthony started with involved in a variety of other organisations in a diverse range of
Baxter in 1978 and has been managing Baxter’s national roles and has published many articles on a wide range of topics,
Customer Service and Homecare divisions in Australia since 2004 most notably a prospective study of Hospital Admissions due to
and New Zealand since 2006. Anthony was awarded the 2006 Drug Reactions (AJHP, 1991, 21, 90-95).
National Customer Service Manager of the Year by the Customer

2009/2010 GS1 Healthcare Reference Book 43

Switzerland

SmartLog: a Swiss drug traceability pilot

Abstract

SmartLog, a Swiss drug traceability pilot supported by Refdata, allowed

all participating organisations to gain a better understanding of the
benefits of an extensive use of GS1 Standards for their daily operations.
Article by Laurent Médioni and
The pilot also highlighted the need for good practices in the delivery
Christian Hay
process, especially between suppliers and hospitals. During 3 months,
almost 39,000 retail packs have been serialised and traced in more than
7,000 events. Cross checks by Swissmedic on about 3.000 data sets
demonstrated the consistency of collected data.

Environment platform for various aspects of the pilot. Smartlog appears to

Pharma market observers in Switzerland considered 2 years be an additional “proof of concept” for the domestic market,
ago trends and projects based on product serialisation, illustrating that similar choices are made in surrounding
RFID and optical data carrier, pedigree and authentication. countries for the next years.
They noticed that these subjects were totally unknown in
the Swiss domestic market. Representatives of wholesalers Narcotic control in Switzerland
and regulators had preliminary talks about the benefit they Narcotic control has been reengineered in Switzerland in
could gather by running a pilot on the field with controlled the early 1990. The purpose was to replace paper work by
drugs as narcotics. Two assets facilitate such a project: firstly electronic data management, which allows increased efficiency
trade of narcotics is monitored by law with a very efficient both in human resources and in sparing public spending. After
system for nearly 15 years; secondly Swiss healthcare an in-depth study, the Swiss narcotic control office launched
disposes since 2001 of a foundation (Refdata) which regulatory changes to mandate the use of GS1 keys to run
objective is to facilitate processes by use of GS1 standards narcotic control. GS1 keys were chosen as they were not
for product and party identification. specific to narcotic control, and thus reduce costs of database
maintenance. Pharmaceuticals are identified in Switzerland
The discussion has been brought to the Refdata board, with a GS1-GTIN since 1984; the Swiss pharma branch
which decided to support the pilot which was then named association (which was leading GS1 use on the marketplace at
“Smartlog”. Refdata’s board defined the scope of the pilot, that time, and replaced since 2001 by the Refdata foundation)
delegated the operations to a team which had to deliver was planning to introduce GS1 identification for Healthcare
reports at the end of the pilot. A major role has been played actors countrywide – a project which suited narcotic control
by both e-mediat Ltd and GS1 Switzerland. E-mediat Ltd office’s needs. Narcotic substances have been listed and
is a subsidiary of Galenica, a major player in the Swiss allocated a GS1 identification key by the narcotic control office.
Healthcare, providing services as data management to the 1994 all the conditions to deploy electronic data collection and
Healthcare industry. E-mediat runs since 2001 on behalf processing were given.
of Refdata the reference databases with GS1 identification
keys for pharmaceuticals and for Healthcare parties. The Broadly, narcotic for medical use are controlled and involve
databases are used for narcotic control, statistics, logistics 50 suppliers, over 1,300 retail pharmacies, 800 hospitals
and health invoicing; their use for eHealth and other areas and 35,000 medical and veterinary doctors. The number of
is encouraged by Refdata. GS1 Switzerland provided its deliveries to be declared to the authority is about
support by involving its user community as a validation 350,000 per annum.

44 2009/2010 GS1 Healthcare Reference Book

 SmartLog: a Swiss drug traceability pilot

The role of the federal narcotic control office consists Refdata has contracted with e-mediat Ltd for the operative
(among else) in collecting the declarations and providing activities, consisting in maintaining and developing the
appropriate information to the local authorities so that they reference databases with GS1 identification keys for the
can proceed in on-site controls where and when necessary. Swiss market.
The power of the narcotic control system is to deliver within
30 days a country-wide picture of all transactions involving Project participants
narcotics for medical use, and therefore concentrate Lead of the pilot is delegated by Refdata to a
on observations revealing peaks and other suspicious pluridisciplinary team grouping representatives of
movements. wholesale, manufacturers, pharmacists and GS1 Switzerland.
E-mediat, a service provider which is managing databases
By disposing of that IT infrastructure (which can be accessed for the healthcare market in Switzerland, has been
through the web: http://www.abeko.swissmedic.ch/) and designated to manage the project and develop the
by building on GS1 identification keys used for several necessary IT infrastructure. Pilot participants were invited to
other purposes on the marketplace, narcotic control monitor the project from its conception to its delivery in a
is managed in the most cost-efficient possible way, by few joint meetings.
providing accuracy and full coverage to the federal and local
authorities. It is further estimated that the user community Technical concept
saves considerable workforces because of the integrated By tracking and tracing individual drug packs, the project
processes with non-specific identification keys. corresponds to the US-Pedigree model; full traceability is
provided by documenting each “event” during the journey
Refdata foundation of each pack, from the manufacturer’s premises (or its
Refdata foundation (www.refdata.ch) has been launched representative), to the dispensing to the patient.
in 2001 to group efforts and to maintain directions
taken by a previous organisation. Its objective consists in The project was planned for a limited time frame: 3
securing identification of pharmaceuticals and healthcare months. As a consequence it was not foreseen that each
providers across the country, with GS1 keys. Nearly all project participant integrates the new processes into its
the Swiss healthcare industry is represented in Refdata’s operational IT environment; a separate “in vitro” framework
board: Associations of Pharmaceutical, Medical Devices has been developed by e-mediat Ltd, which allowed some
manufacturers and wholesalers; for the care givers, the simplifications (i.e. only one “event” database; central serial
associations of medical doctors, pharmacists, droguists number allocation).
and hospitals; for the insurance side, the association of
illness insurers and the pool of federal insurances (accident, The set of operations was therefore built on a web-
disability, etc.). Swissmedic and the Federal Office for Public application with a safe level of protection and access. Each
Health participate as observers. project participant accessed the web-application with its
own data and had visibility to the previous and the next step

2009/2010 GS1 Healthcare Reference Book 45

SmartLog: a Swiss drug traceability pilot

in the supply chain. Only Swissmedic benefit of full overview The pilot was limited to 3 months: compliance in
through the supply chain, so that comparison with the usual maintaining separate, additional processes on a relatively
monitoring system became possible. large scale was a challenge; it was not necessary for the
pilot to request longer efforts from the participants.
At the end of the project, participants are informed about 38,825 retail packs have been serialised and traced in
aggregated data, whilst Swissmedic receives all details to 7,221 events. Because the small number of participating
assess the results towards the usual monitoring system. pharmacies, only 281 retail packs made their journey
within project participants. Manufacturer (pre-wholesalers)
Project participants delivered 23,504 retail packs to project participants, mostly
and selected project products wholesalers. Cross checks made by Swissmedic on about
Four Pharma Manufacturer (Janssen-Cilag, Mundipharma, 3,000 data sets, based on the narcotic control processes in
Novartis Pharma [pre-wholesaler: Voigt], Pfizer [pre- place, and demonstrated consistency of the collected data
wholesaler: Alloga]) joined the pilot by selecting one pack within Smartlog. The reduced number of discrepancies
size of one of their controlled products. All the wholesalers (~1%) concerned recipient identification in
participated with a small number of retail pharmacies.
The project did not address hospitals: the supply chain Smartlog’s records and was due to the non-integration of
to hospitals in Switzerland is very simple because they the processes and to human errors in selecting the recipient
are usually supplied directly from manufacturers or their of a delivery.
representatives.
Project outcome
Participant feed-back has been very positive in general.
Without surprise, wholesalers declared that optical marking
is not appropriate to track and trace at the speed they have
to work in preparing deliveries. Retail pharmacies expressed
their interest in disposing of a better instrument for their
stock management, including the management of recalls.

Smartlog raised questions about ownership, access to and

sharing sales data. During the pilot, participants had only
access to their direct supply chain data (one step before,
one step after). This met requirements on data ownership.
As an instrument to fight against counterfeiting, individual
product tracing needs the development of intelligent tools
to automatically discover unwished entrants in the supply
chain as well integrity disruptions. The intelligent tools will
alert concerned parties with appropriate information each
Before being sent on the market, the selected retail packs time suspicion of counterfeiting is captured.
were stickled with a linear barcode and a Datamatrix. The
two data carriers included a GS1 data structure, the linear Because of its simplified organisation Smartlog did
GS1-128 including only the GTIN and the serial number of not include the “intelligent tools”, which in return were
that retail pack, whilst the Datamatrix included GTIN, lot, recognised by project participants as a key to meet the
expiry date and serial number. With the double bar-coding, objective of fighting counterfeiting, whilst respecting
project participants wanted to secure that any retailer ownership of sales data.
could participate to the pilot without needing to purchase
a new scanner. Smartlog’s outcome is published in two reports: a technical
report, explaining the project from its origins to its
achievement, and a strategic report presenting learnings
and statements as a message to the community.

46 2009/2010 GS1 Healthcare Reference Book

 SmartLog: a Swiss drug traceability pilot

Example of product flow for Swissmedic

SGTIN
event

GLN

GLN Prescribing MD

Patient (anonym)

Conclusions and vision For GS1 Switzerland’s user community, Smartlog helped
From a series of articles in the specialised press across understand the need to develop good practices in the
the country to the adoption of the final reports, through delivery processes, especially between suppliers and
the running of the pilot, numerous actors in the Swiss hospitals. A working group has been set up immediately
healthcare have developed a better understanding of after Smartlog to address this subject.
the benefits of an extensive use of GS1 standards for their
daily operations. The reports, which are publicly available We expect the federal authorities to dispose of a good
(www.gs1health.net/smartlog), list statements and lessons information base in the case of any sudden incident
which help stakeholders in preparing future activities. This involving the trade of counterfeited drugs, through the
includes hospitals, even if these were not part of the pilot (in usual supply chain.
Switzerland hospitals are currently mainly supplied by the
manufacturers or their local representative; the supply chain
is therefore the most direct possible and excludes practically
any counterfeiter to supply its pharmaceuticals to hospitals).

Authors

Laurent Médioni is currently canton’s pharmacist in Fribourg. He Christian Hay works currently for GS1 Switzerland and
was previously head of the Swiss narcotic control office and led GS1 Global Office. Educated as a lawyer, he worked for the
the reengineering of narcotic control in the early 1990. He started pharmaceutical branch since mid of 1980s in various positions.
his career as a hospital pharmacist in a regional hospital before He was involved since the early stages in GS1 standard
joining his first position as canton’s pharmacist in Neuchâtel. deployment in the Swiss healthcare.
Beside narcotic control, canton’s pharmacists are in charge of
surveying retail and hospital pharmacies and to maintain plans
for public health, as in the case of pandemics.

2009/2010 GS1 Healthcare Reference Book 47

Canada

Transforming the Canadian healthcare

supply chain: creating the future roadmap
for success

Abstract

This article describes the efforts that are underway to create a

standardized healthcare supply chain in Canada, affecting change and
eliminating obstacles that have prevented full adoption in the past.
Article by Herb Martin
Recent developments will accelerate the creation of one of the most
modern supply chain systems in the world, with the full involvement
of the government, healthcare provider (i.e. hospital), supplier, group
purchasing organizations (GPO), and service provider communities.

Introduction standards in healthcare institutions and retail pharmacy

Looking back, there is little doubt that 2008 will be in order to improve patient safety, cost efficiency and staff
considered a major turning point for the Canadian productivity, ultimately ensuring that Canada’s healthcare
healthcare supply chain. Two organizations with similar trading partners are able to fully operate in an increasingly
goals and aspirations – standardized supply chain, state e-driven global supply chain reality.
of the art electronic commerce environment and cost
reduction – amalgamated into a single organization with a The Board views the pharmacy supply chain from the point
common objective: patient safety. CareNET, an association of manufacturing to the point when the pharmacist receives
of healthcare facilities and suppliers across Canada, signed payment for prescriptions, including the insurance claims
an agreement to amalgamate with GS1 Canada. Equally as process. Traceability has been positioned as the foundational
important, various provincial governments provided funding supply chain element to drive efficiencies and safety.
and leadership to expedite the movement to a supply chain
that utilized GS1 global standards. These events will enable Projects to enable complete supply chain traceability
Canada to create a sustainable model for the future – a include the identification of Canadian requirements in
model that will achieve the supply chain goals that the pharmaceutical product identification (such as information
entire industry has strived to attain for so many years. A imbedded within a bar code), the population of a national
15-month initiative, the Canadian Healthcare Supply Chain pharmaceutical product registry, as well as the GS1
Standards Project, will develop the necessary standards Canada Certificate of Authority Service, which enables the
and provide implementation guidelines and tools to drive secure, electronic procurement and tracking of controlled
consistency and interoperability across the sector. substance (narcotics) orders.

In a parallel initiative, GS1 Canada also has made significant Background

inroads in the pharmacy sector, among both retail pharma- In the late 1990s, a group of industry leaders – including
cies and pharmacy sites within the hospital community. The healthcare institutions, suppliers and GPOs – formed a
GS1 Canada Healthcare Pharmacy Sector Board is comprised Canadian version of Efficient Healthcare Consumer Response
of 18 senior executives. The Board identifies projects that (EHCR). This committee proceeded as a healthcare sector-
support the adoption of a common system of supply chain driven initiative with a mandate to significantly reduce

48 2009/2010 GS1 Healthcare Reference Book

healthcare supply chain costs. Ten years later, the committee been experienced by others, including grocery and retail. The
no longer exists and many of the recommendations that vision of tracking and tracing all healthcare products – from
were not fulfilled still remain as valid now as they did then. the point of manufacture to the point of use (patient bedside
Why did this happen? The most often-quoted reason is scanning) – would result in an efficient and safe supply chain.
that all of the past efforts were made by volunteers who
devoted as much of their time as their full-time employment At the close of 2008, CareNET members voted and the
would allow, but it simply wasn’t enough. As well, funding agreement was signed to amalgamate with GS1 Canada.
and strategic priorities pushed supply chain projects to
the back-burner. However, as we progress, supply chain Another 2008 milestone occurred when GS1 Canada,
perception is shifting from simply moving boxes to becoming with CareNET’s strong endorsement, received approval
the key enabler of patient safety, traceability, sustainability, for its application for funding from the Ontario Ministry of
interoperability and cost containment. Looking back at the Finance’s OntarioBuys program to promote supply chain
events of history has provided the motivation to ensure that efficiencies for its broader public sector (hospitals, schools,
this situation does not reoccur. universities, etc.). The application outlined the first three
phases of an ambitious program to define and implement
CareNET represents over 450 hospitals across Canada, more a standards-based structure for the healthcare supply
than 95 suppliers and distributors, and the two national chain. OntarioBuys agreed in principle to fund up to 70%
GPOs (HealthPRO Procurement Services Inc. and Medbuy of the proposal entitled the Canadian Healthcare Supply
Corporation). Since 1990, CareNET has been instrumental Chain Standards Project, subject to GS1 Canada receiving
in promoting the advancement of electronic commerce commitment for the remaining 30% from other provincial
(e-commerce) in the healthcare sector, along with the jurisdictions and corporate enterprises. OntarioBuys
e-commerce standards for electronic trading, with a goal of added the stipulation on partial funding to ensure that all
reducing supply chain costs. of Canada was behind this new approach to healthcare.
By implementing an aggressive outreach campaign, GS1
Since 2007, GS1 Canada has been moving forward with Canada has received approval for over half of the remaining
its plan to integrate GS1 standards into the Canadian 30% from the provincial governments of British Columbia,
healthcare system. GS1 Canada’s goal is to introduce to the New Brunswick, Nova Scotia and Alberta, as well as a
healthcare sector the same efficiencies that have already number of corporate contributions.

2009/2010 GS1 Healthcare Reference Book 49

Transforming the Canadian healthcare supply chain:
creating the future roadmap for success

The New Direction between the two boards. The pharmacy board is also
All of the necessary building blocks are in place to create the supported by a Pharmacy Standards Work Group.
groundwork for future success. Already, we are beginning to
see the results of these efforts, including: The proper structure for future success is now in place.
CareNET brings the membership of devoted providers,
• The former CareNET Board of Directors (10 hospitals, 10 suppliers, GPOs and service providers to the table.
suppliers) remains in place as the CareNET Healthcare GS1 Canada brings an association with many years of
Sector Board in GS1 Canada, with the mandate to set the experience in e-commerce and supply chain standards.
future direction for healthcare in Canada More importantly, the onerous demands on volunteers to
continue the momentum will be supplemented with the
• A majority of board members have also agreed to partici- experience of GS1 Canada staff.
pate on a newly-formed CareNET Healthcare Standards
Council to approve the future direction for healthcare What Are We Trying to Achieve?
standards development and implementation timelines Our ultimate goal is to achieve a standardized, efficient
healthcare supply chain. This very simplistic statement,
• A Healthcare Technical Standards Working Group although it defines the objective, requires a great deal of
has been formed to create the standards for future advance planning and work.
e-commerce in healthcare. This group of more than 30
individuals from across Canada, comprised of hospitals, Clearly, the initial benefits are obvious. By implementing
suppliers, distributors, GPOs, network gateways (Value- a standards-based supply chain, using technologies that
Added Networks) and service providers, will prepare the are designed with a global perspective, reduced costs will
recommendations for future standards and forward them accrue to both the provider and supplier community. This
to the CareNET Healthcare Standards Council for approval. cost effectiveness will enable additional funding to be
directed to patient care.
The GS1 Canada Healthcare Pharmacy Sector Board will
have a representative on the CareNET Healthcare Sector Moreover, using global standards – such as Global Trade
Board, and vice versa, to ensure the transfer of knowledge Item Numbers (GTINs) and Global Location Numbers

CareNET Hospital Member Growth

500

450

400

350

300

250

200

150

100

50

0
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

50 2009/2010 GS1 Healthcare Reference Book

 Transforming the Canadian healthcare supply chain:
creating the future roadmap for success

(GLNs) for product and location identification, respectively To properly develop the systems of the future, Canadian
– throughout the supply chain will enable track and trace healthcare must define the basic requirements for the
systems and automated product recall systems. Industry- exchange of electronic business documents. These basic
adopted attributes and the exchange of clean data between requirements will include global data requirements such
trading partners will ultimately become entrenched in as GTINs and GLNs to facilitate the tracking of products
healthcare systems and drive efficiencies. throughout the supply chain. Just as the retail and grocery
sectors have successfully demonstrated for many years,
The final achievement will be enhanced patient safety. Future guidelines for basic bar coding of all medical products
systems will track a product throughout the entire supply entering the healthcare supply chain will be implemented
chain, from point of manufacture to point of use at the and enforced. As Radio Frequency Identification (RFID)
patient’s bedside, ensuring that the right patient receives the becomes a widely used technology in healthcare, the
right dose of the right medication at the right time. standards will be implemented and available for all members.

Canada is not unique in moving forward with this plan for With all trading partners moving forward with a common
the future. This strategy is directly linked to the global GS1 set of global standards, products that arrive from within and
Healthcare initiative. Although we track the efforts of other outside Canada can move through the supply chain with
countries, we are confident that we shall soon have in place confidence, and can be tracked to determine both their
a sustainable model for others to follow. origin and their final destination.

The Global Perspective Conclusions

For the past 20 years, Canadian healthcare has been As of Spring 2009, we are now well on our way to creating
advancing its electronic transaction processing infrastructure, a foundation for future success. The critical components of
as more hospitals and suppliers upgrade and enhance their this foundation are:
back-office systems to provide the functionality required by • Start-up funding
their trading partners. Although there have traditionally been • Strong government support
shortcomings in the information exchange, for the most part, • Commitment from all stakeholders in the healthcare
the advancement of electronic commerce has served the industry, across the entire country
healthcare industry well. • Combined efforts of a strong healthcare association and
GS1 Canada
We are now at a stage when we must assess the current • The creation of a sustainable model for the future.
environment and establish an industry roadmap for the
future that incorporates both the experience that has
been gained over the past years and the requirements for
future technological changes and demand to operate a
sustainable, efficient and safe healthcare system.

Author

Herb Martin, in his role as the CareNET Manager, is responsible will identify projects that will support the adoption of a common
for the administrative tasks associated with the day-to-day system of global supply chain standards in healthcare institutions.
operations of CareNET. CareNET is Canada’s healthcare sector CareNET’s goal is to improve patient safety, cost efficiency and
strategy to standardize the healthcare supply chain. Through its staff productivity, and ultimately ensure Canada’s healthcare
amalgamation with GS1 Canada, CareNET represents over 450 trading partners are able to fully operate in an increasingly
Canadian healthcare providers and 95 leading suppliers. CareNET e-driven global supply chain (www.carenet.ca).

2009/2010 GS1 Healthcare Reference Book 51

Germany

Return on investment of standardised bar

coding at Herz-Zentrum Bad Krozingen

Abstract

At the Herz-Zentrum Bad Krozingen, cost unit billing according to

Diagnosis-Related Group (DRG) guidelines used to be time consuming and
prone to error. The hospital has investigated the impact of the introduction
Article by Holger Klein
of standardised bar coding: in addition to saving a significant 78% in
documenting consumed materials, it has also shown that efficient, accurate
DRG calculation is only possible when data is automatically entered by
scanning the bar code. A cost-benefit analysis showed that the initial
investment already paid for itself in the first year.

Background On the other hand, the cost unit accounting data is supplied
The Herz-Zentrum in Bad Krozingen is a hospital specializing to the Institut für das Entgeltsystem im Krankenhaus (InEK)
in the treatment of cardiovascular diseases. It has GmbH for review, as required by law.
departments for cardiology, angiology and cardiovascular
surgery. The Herz-Zentrum has a total of 256 beds. Table 2: Sample data supplied to InEK GmbH (sample data)

Cost Cost
The project was initiated in response to the time-consuming Releasing In-hospital centre type Purchase
cost unit billing by Diagnosis-Related Groups (DRG IK location code group group price (€)

calculation): When the project started in 2006, some 65% of IK No Inventory No 7 1 1,456.53

medical requirements were entered to “cost units”, namely IK No Inventory No 7 3 247.59

patients, and the manual processes required much effort. IK No Inventory No 7 4a 29.07
IK No Inventory No 7 5 1,926.00

On the one hand, the hospital uses cost unit accounting as IK No Inventory No 7 6a 189.35

an instrument for efficiency controlling. IK No Inventory No 7 6b 7,157.42

IK No Inventory No 7 7 253.92
IK No Inventory No 7 8 239.18

Table 1: Excerpt from cost unit accounting per DRG case (sample data)

Booking Amount Voucher Booking Cost Cost centre

date KoA Description Quantity BzGr (€) number Voucher date BP text centre description
Medical and
Outgoing
12.10.2007 660400 nursing 2 st 30.09 10585 30.09.2007 9 92232 Electrophysiology
invoice
consumables
Electro-
Outgoing
12.10.2007 661003 cardiogram 1 st 32.13 10585 30.09.2007 9 92232 Electrophysiology
invoice
requirements
Intracardiac Outgoing
12.10.2007 661350 10 st 7,095.20 10585 30.09.2007 9 92232 Electrophysiology
catheters invoice
Outgoing Intracardiac
12.10.2007 661342 Stents, coated 2 st 1,926.00 4234 30.09.2007 9 92019
invoice catheters

52 2009/2010 GS1 Healthcare Reference Book

 Return on investment of standardised bar coding
at Herz-Zentrum Bad Krozingen

Preparation for the Herz-Zentrum Bad Figure 1: GS1 master data in the hospital
Krozingen project
The project was approved by the hospital management in
February 2005 and has been in production since September
2007. The relatively long project duration was necessary so that
suppliers could have the opportunity to identify their products
with GS1 barcodes in accordance with the requirements.

A prerequisite for using scanners is that a product’s master

data be available and incorporated in the inventory
management system. The first task was therefore to enter
the GS1 item numbers of the suppliers. The challenge for
the hospital was less in making IT adjustments, since the
materials management system it uses is GS1-compatible,
than in universally identifying products with barcodes.
Before and after
An initial classification and stocktaking of the relevant items Three basic process steps were identified before scanners
in March 2005 showed that a large number of suppliers were introduced:
had not identified their products with barcodes. In those • documentation in the functional departments
cases where suppliers had identified their articles with • entering materials in accounting
barcodes, the challenge was to analyse the various barcode • controlling upstream allocation of special products to
systems and impose a single standard, namely GS1. Non- patients.
GS1 barcodes meant an extra step was needed to enter the
batches and serial numbers that are necessary for sending Because the manual system was so prone to errors, time
invoices to consignment warehouses and to comply with was also spent on harmonising the entry of activities and
statutory documentation requirements. materials.

Figure 2: Schematic process flow before

In order to conduct the project at all, the hospital decided
scanners were introduced
on a stopgap solution: sufficient time would be dedicated to
making IT adjustments so that this latter system could also Documentation Controlling
Data entry in
be handled. in functional material
accounting
departments allocation

At the same time, with the support of GS1 Germany, the

hospital asked the suppliers that still did not have any Consumed materials were not entered directly by the
barcodes and those that had not worked with GS1 to identify functional departments, but subsequently entered
their products according to uniform GS1 standards. Suppliers’ manually by the accounting department. In the functional
reactions were largely positive and in some cases products department, labels were cut out from the consumed
were even relabelled specifically for the hospital. products or the patient labels often included by the
manufacturer, were stuck on and passed on to the
As a result, two facts became clear: First, that hospitals can accounting department by internal post.
get things moving and, second, that manufacturers have
become more aware of the benefits of GS1 standards. Also after scanner systems were introduced, the initial
documentation on consumed materials remained the
By summer 2006, the majority of products had GS1 barcodes responsibility of the functional departments. However this is
and after consultation with the specialised departments, the now done by scanning the GS1 barcodes on the consumed
project could start. After the scanners were purchased, a test products. Materials are allocated directly to the patients
run was conducted, and after a successful run, the actual through the IT system. Data entered in this way is thus
project was implemented in two catheter laboratories. available in fully electronic form for all further processes,

2009/2010 GS1 Healthcare Reference Book 53

Return on investment of standardised bar coding
at Herz-Zentrum Bad Krozingen

so that the accounting department is spared the time-

consuming and error-prone entry of consumed articles and
manual allocation to the patient when controlling.

Figure 3: Manual documentation of consumed articles in

functional departments

Information had to be manually entered and allotted to the

individual patients which, depending on how many there
were, took several days per monthly report.

After implementing the automated process in the functional

departments, the accounting department was spared
the entire entry procedure when it comes to controlling
and allocating special products to patients in the catheter
laboratories in question. Both tasks could be eliminated.

Table 4: Before and after comparison: data entry in the

accounting department

Average time Number of Total time

There is no more need for patient stickers or cutting out spent per processes spent
process p.a. p.a.
labels. Instead, one simple and quick scanning procedure
Before 00:01:25 1,260 29:45:00
enters GS1 numbers, batches, serial numbers and in some
After 00:00:00 1,260 00:00:00
cases expiry date, or any other relevant data for subsequent
Time saved 00:01:25 29:45:00
procedures.

For the functional departments in the hospital to document

Table 5: Before and after comparison: Materials allocation
consumed articles, the use of bar codes resulted in work
in the control system
time savings of 78%.
Average time
Table 3: Before and after comparison: documentation in Number of Total time
spent per
processes p.a. spent p.a.
functional departments process
Before 00:07:48 2 15:36:00
Average time Number of Total time
After 00:00:00 2 00:00:00
spent per processes spent
process p.a. p.a. Time saved 00:07:48 15:36:00
Before 00:03:10 1,260 66:30:00
After 00:00:42 1,260 14:42:00
The entire process flow was not only inefficient but also
Time saved 00:02:28 51:48:00
associated with a high error rate, since labels could go missing
or product packaging could be forgotten and not passed on
Before, the accounting department used to receive as anticipated. There was also the risk that materials could be
documentation or a brightly coloured bunch of cut-out allocated to and documented for the wrong patient.
labels, with a delay, via internal post from the functional
departments. As a result of this automated process, a basis has been created
for forwarding accurate data to InEK for payment of hospital
services.

54 2009/2010 GS1 Healthcare Reference Book

 Return on investment of standardised bar coding
at Herz-Zentrum Bad Krozingen

Payment by InEK GmbH for hospital services is therefore also previous six to seven hours. The available data is reliable
incorporated in the overall analysis: and the hardware can be used flexibly for a wide range of
processes.
Table 6: Payment based on DRG calculation

Number of cases Total revenue p.a. The data scanned in by the functional departments is
p.a. (€2.03 per case) available to other departments for downstream process steps.
Before 0 €0.00 Transparency is increased since every area works with the
After 942 €1,912.26 same information. Additionally, it is now possible to simplify
Revenues €1,912.26 medical documentation, since the scanned product data,
including batch numbers, can be transferred into medical
An analysis of the documentation process as a whole gives documentation. This not only reduces the time spent on
the following result: entering data but also avoids potential sources of error that
can result from data that is classified or entered incorrectly.
Table 7: Time saved in the Herz-Zentrum Bad Krozingen

Process Time saved p.a. With the transparency that is created, products can also
Documentation in the functional departments 51:48:00 be traced within the organisation, since consumption and
Entry by the accounting department 29:45:00 movement of goods can be documented automatically. In
Controlling the allocation of materials 15:36:00 the event of recalls, the products in question can be located
Total 96:39:00 and returned quickly and systematically. Not only does the
use of automatic data entry systems make sense for products
where documentation is mandatory, but in the long term all
Greater transparency, safety and quality medical goods are likely to factor in such considerations for
In addition to the cost savings, there are also qualitative the sake of increased efficiency and patient safety.
benefits of scanner systems and uniform standards, such as
greater data transparency, safety and quality. In the hospital, the project encountered extremely positive
reactions, resulting in the gradual inclusion of other
Since the continuous entry of consumed material provides operational areas. With the support of management and staff
up-do-date figures of the articles in stock, the entire in the various departments, it will not be long before the
ordering process can be automated. When stock falls below hospital sees this project become part of daily practice.
a predefined amount, an order is automatically triggered.
This does away with stock planning, leading to yet another Since parallel processes lead to unnecessary expenditure of
enormous saving of time. If required, the purchasing time and the benefits speak for themselves, the hospital’s
department can also monitor stocks in real time. message to its suppliers is unmistakable: products need to
be identified with GS1 barcodes across all packaging sizes,
The Herz-Zentrum Bad Krozingen has established that enabling universal use from production to patient.
stocktaking takes only around 1.5 hours instead of the

Author

Holger Klein is Head of Inventory Management and Logistics at career at Herz-Zentrum Bad Krozingen within the procurement-
Herz-Zentrum Bad Krozingen in Germany, a health service centre and materials-management-department. Mr. Klein has extensive
specialised in cardiology, heart surgery, vascular surgery and experience within the healthcare sector and has been leading
angiology. Having finished his apprenticeship in international various standardisation projects. He was responsible for
business successfully, Mr. Klein studied business management optimising logistic processes in Bad Krozingen, including the roll-
at VWA (business college) in Freiburg. Afterwards he started his out of a scanner-based ERP system.

2009/2010 GS1 Healthcare Reference Book 55

Spain

Efficiency models in the Andalusian

Health Service supply chain

Abstract

The Andalusian Health Service (SAS) is setting as their strategic objective

the integration of the available logistics resources under a common
operating model to enable their effective and efficient coordination. One of
Article by Jesus Gavira
the initiatives adopted by SAS includes the definition and establishment of
coding and symbol requirements by means of GS1 standards for products
purchased by the Andalusian Health Service. The aim of this initiative is
to promote the effective use of automatic product identification systems
within the supply chain of health centres, in order to maximise the reliability
of identification of the product and of its characteristics during use and
during the management of its logistics movements.

Background focus which is based on each Primary Health Care Hospital

The Servicio Andaluz de Salud / Andalusian Health Service or District being equipped with a budget, a logistics system
(SAS) is an autonomous body affiliated to the Ministry and the decision-making capacity to manage it, has been
of Health of the Autonomous Regional Government of replaced by a systemic and integration-centred focus; a
Andalusia. Its aim is to provide public health services to the collective corporate vision based on the intensive use of
citizens of Andalusia. information and communication technologies (ICT).

Serving an area of 87,268 km2 and a resident population of over The inefficiencies resulting from a “multicentric” focus,
8 million inhabitants, the Andalusian Health Service provides which requires the provision of logistics resources in each
its primary and specialised health care via 1,491 primary care institution without taking into account the possibility of
centres, 29 hospitals and 8 blood transfusion centres. sharing organisational facilities or systems, and which is
the dominant model in public health systems and in some
It is equipped with 83,132 health care professionals (2007 private health networks, can and must come to an end
data) and a budget of 8,751,387,000 Euros (2008 data) for the by means of establishing integrated networks of logistics
purposes of providing these services. resources.

These figures give a clear idea of the magnitude of the At the beginning of this transformation process, the
challenge of equipping this organisation with a corporate Andalusian Health Service is setting as their strategic
logistics solution that meets the supply chain requirements objective the integration of the available logistics resources
of all its preventive care, medical assistance and health under a common operating model to enable their effective
promotion systems and services. and efficient coordination.

Transformation of purchasing Two central lines of analysis are distinguished under this
and logistics services approach: the first of these is to examine and assess the
The organisation of purchasing and logistics services has logistics resources available in the Andalusian Health
evolved significantly over the last decade. The “multicentric” Service. The second is to outline their integration strategy.

56 2009/2010 GS1 Healthcare Reference Book

 Efficiency models in the Andalusian
Health Service supply chain

The development of these initiatives takes two different

forms: firstly, the concept of the Corporate Logistics
System, defined as the collection of facilities, material and
professional resources and organisational means aimed
at meeting needs in this regard in the Centres. Secondly,
the Integral Logistics Management System – Spanish
initials: SIGLO®, set up as the group of IT applications used
for the management of the logistics procedures carried
out via the Corporate Logistics System, and which, in turn,
takes the form of two main lines of analysis, one of which
concerns goods, and the other dealing with issues regarding
information and business messaging. that match the specifications of the buyer, once the
corresponding validations have been carried out on
From this point on, the Andalusian Health Service is to the product and on the information provided on the
embark on the following courses of action: product. It is an essential step for becoming a supplier of
the registered product.
1. Establishing infrastructures to enable traceability • Validation of the coding structure and the symbols used.
and efficient logistics management. The validation of the logistics information provided
by the supplier is critical for the correct identification
The initiatives that come under this heading aim to process of goods in the logistics chain. The guarantee
introduce those basic elements of infrastructure into the of accuracy of the information provided via the product
supply chain on which a secure and efficient logistics catalogue and of basic quality of representation of the
management model will subsequently be built. The symbols on the containers and packaging of the goods
initiatives adopted by the Andalusian Health Service include supplied is essential for the establishment of efficient
the following notable examples: models of logistics management. To this end, the
• Definition and establishment of coding and symbol Andalusian Health Service has drawn up two courses of
requirements by means of GS1 standards for products action: the first aims to guarantee the consistency and
purchased by the Andalusian Health Service. validity of the logistics information provided; the second
The aim of this initiative is to promote the effective use aims to examine the technical adaptation of the symbols
of automatic product identification systems within the (bar codes) used by the suppliers on their containers
supply chain of health centres, in order to maximise and packaging and their consistency with the logistics
the reliability of identification of the product and of its information provided, both on the samples requested
characteristics during use and during the management and on the goods supplied to the Centres.
of its logistics movements. • Purchasing policy based on the prior approval of
The level of establishment achieved has greatly suppliers and products.
improved the outlook for this sector. A corporate purchasing policy must be drawn up and
• Alignment of files with suppliers. Product catalogue implemented, which, in addition to improving the
The product catalogue of the Andalusian Health Service efficiency of the Centres as purchasing agents, and
is supported by an IT platform which the suppliers of therefore the global position of the organisation in the
our organisation can access via the Internet Portal of market, will direct and encourage the supply companies
the Andalusian Health Service (www.juntadeandalucia. toward the points of interest of the corporate operations.
es/servicioandaluzdesalud) in order to provide This is the case with the identification of products using
information on the technical, identification and logistics GS1 standards or the conditions of transfer of the goods
characteristics of the products that they wish to market from the supplier to the buyer via Logistics Development
to our organisation’s centres. It is the channel for aligning Agreements and Logistics Specifications Forms as
the product catalogue required by the Andalusian elements incorporated into the supply contract, which
Health Service with those products available on the shall be dealt with later in the text.
market (with each of the companies that sell them) • Policy of maximum information for purchases.

2009/2010 GS1 Healthcare Reference Book 57

Efficiency models in the Andalusian
Health Service supply chain

Corporate policies which are based on the decentralisation

of the purchasing function, such as that developed by the
Andalusian Health Service, require the implementation of
strategies of maximisation of information for purchases,
especially with regard to the technical information
concerning the characteristics of the product and the
approval fees and actual purchase prices.

2. Normalisation and generalisation of requirements

in relation to logistics services for purchases. Logistics
Development Agreements. Logistics Specifications
Forms. Deposit Management Agreements. an internal examination of the organisation’s centres by
means of an information collection protocol supported by a
The need to include a number of clauses in a systematic corporate-wide IT application (Logistics Accreditation System).
and homogeneous form in supply contracts to govern the Completion of this process allows, among other objectives,
transfer process of goods from the supplier to the buyer, as the accreditation of conditions for the future establishment of
indicated above, has brought about the normalisation and the SIGLO® platform, referred to below.
systematic use of a number of logistics practices that due to
their nature must be the result of a consensus between the This accreditation process, in which all the Centres of the
parties involved. The nature of the supply chain requires this. Andalusian Health Service are involved, enables the actual
The Andalusian Health Service has developed and sought magnitudes and descriptive characteristics of the Corporate
a consensus with the main representative organisations of Logistics System to be determined.
its suppliers on the conditions that ought to govern these
practices, both in the case of storable goods (Logistics 4. Identification and normalisation of management
Development Agreements) and in the case of goods supplied processes and procedures.
under an assisted storage arrangement, such as surgical
implants (Storage Management Agreements). The prior and The second of the aspects addressed in the accreditation
specific knowledge of the logistics aspects that must be process focuses on the identification of the principal
implemented in order to fulfil the contract are essential for processes and procedures, in other words, those which form
the subsequent monitoring of their performance and for the part of the common nucleus of operations taking place in all
correction of any potential deviations. the Centres (entering into transactions, order management,
reception of goods, storage, etc.).
3. Identification and inventory of facilities, material and
professional resources and organisational means used Having identified these processes and indicated the units
for logistics purposes. Logistics Accreditation System. responsible for carrying them out, the next step is the nor-
Configuration of the Corporate Logistics System. malisation and standardisation of these procedures in order
to incorporate them into the collection of utilities that make
Addressing the “logistics issue” in an organisation of the size up the management system contained in the SIGLO® platform.
and complexity of the Andalusian Health Service requires In this way, a standardised group of procedures is established
several methods of approach. The analysis of the material which must incorporate all the users of the platform.
resources used for this purpose, which the initiatives described
in this section refer to, is essential as they represent a direct 5. Design of the SIGLO® platform.
source of costs in the system that must be managed.
For the management of the Corporate Logistics System,
Therefore, the examination and inventory of the facilities, understood as the material and tangible component of the
material and professional resources and organisational means logistics resources, as well as of the management processes
used for maintaining the logistics systems in the centres and procedures, this platform focuses its course of action
forms part of an internal accreditation process that requires in two directions: the management of goods and their

58 2009/2010 GS1 Healthcare Reference Book

 Efficiency models in the Andalusian
Health Service supply chain

traceability, and the management of business messaging prior verification of fulfilment of the former.
which, as an Electronic Data Interchange (EDI), drives and The generalisation of this strategy shall entail a far-reaching
intervenes in the supply chain. transformation of both the management of goods and
the management of messages that drive their movement
• Management of goods. Traceability. through the supply chain, thereby resulting in considerable
The procedures incorporated into the functional improvements in the efficiency of the internal processes
design of this platform have been based on the full and a considerable reduction in the costs of management
implementation of the GS1 identification standard, of goods.
thereby completing the course of action described in
the preceding paragraphs. 6. Improving the efficiency of the logistics system:
This set of initiatives aims to improve the control and redesign strategies.
logistics management of the goods moving through the
supply chain, as well as their traceability. As has already been emphasised, the SIGLO® management
The automation of the process of receiving orders and platform must enable all its users to operate under the same
their validation, the elimination of errors and incidents operation model, given that its management procedures
during processing, the accurate knowledge of the are shared.
levels of stocks in storage, the correct preparation and
management of orders for restocking and distribution, This condition enables us to understand the Corporate
and the monitoring of consumption, among other Logistics System as a network in which each node (Centre),
factors, are benefits that are hoped to be obtained in which until now has functioned in an autonomous and
each of the Centres following the implementation of this unconnected manner, is integrated into a coordinated and
system, thereby considerably improving the efficiency interactive structure. This evolution is only possible with the
of certain processes that currently involve a significant establishment of a common “intelligence”, a logical system
administrative workload. In addition, we must consider which harmonises and coordinates the operation
the possibility of integrating resources so as to favour of all its nodes.
their shared use, given that the management tools and
the organisational bases are shared. We shall address this Irrespective of the direct improvements in the internal
matter in the final section. efficiency of each node that this entails, this measure enables
• Management of business messaging (EDI) us to establish a new analysis and redesign approach for the
The automation of the goods identification process Corporate Logistics System. We must not forget that a logistics
by means of the systematic use of bar codes must system currently exists for each Centre within this network.
be completed with the establishment of a standard
protocol of communication of business messages A significant reservoir of improvement initiatives therefore
between the agents involved in the logistics chain. exists for the global efficiency of the logistics system, which
The Andalusian Health Service has, as an initial step, must explore the standardisation and the shared use of
integrated the following into the functional structure logistics resources on the basis of an efficient
of the SIGLO® platform: use of the order messages distribution system.
(ORDER), delivery note (DESADV), confirmation of
reception (RECADV) and invoice (INVOIC), so that close We shall devote our attention to
monitoring can be established for each step as of the this issue in the future.

Authors

Jesus Gavira is Deputy Director of Purchasing and Logistics in Medicine and Surgery by the University of Seville, graduated
of the Andalusian Health Service. He is also a member of the in Public Health and health Administration by the Andalusian
Committee of the Sector Health of GS1 Spain and coordinates School of Public Health, and has a Master in Economy of the
the activities of the Technical Commission of Purchases and Health and Sanitary Management by the Central Universities and
Logistics of the National Health System. Mr. Gavira holds a degree Pompeu Fabra of Barcelona.

2009/2010 GS1 Healthcare Reference Book 59

60 2009/2010 GS1 Healthcare Reference Book
A publication of:

GS1 Global Office

Blue Tower, Avenue Louise 326, b10
BE 1050 Brussels, Belgium
T +32 (0)2 788 7800
F +32 (0)2 788 7899
www.gs1.org/healthcare
Publisher: Ulrike Kreysa, Director Healthcare, [email protected]
Editor: Jan Denecker, Marketing Manager, [email protected]

Date: May 2009

GS1 AISBL
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Avenue Louise, 326, b10
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T +32 (0)2 788 78 00
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