Bar Codes for the purposes of Automatic Identification and Data Capture (AIDC)

Transcription

1 Bar Codes standard (for the purposes of AIDC) Requirement for a Fundamental Information Standard Programme Prog. Director Owner Authors AIDC Document Record ID Key Mark Ferrar Status Third Draft NHS CFH Version 0.3 Neil Lawrence John Jenkins Version Date Bar Codes for the purposes of Automatic Identification and Data Capture (AIDC) Requirement for a Fundamental Standard

2 Glossary of Terms: List any new terms created in this document or any short forms (abbreviations, acronyms). Term Acronym Definition AIDC AIDC Automatic Identification and Data Capture EAN EAN The name of the information standards before they were re-branded as GS1 GTIN GTIN Global Traded Item Number GLN GLN Global Location Number GSRN GSRN Global Service Relationship Number NHS INFORMATION STANDARDS BOARD SUBMISSION Page 2 of 45

3 Table of Contents Bar Codes Requirement for a Fundamental Information Standard Table of Contents... 3 Preface Standard Demographics Purpose and Scope Business Justification Development and Implementation APPENDIX A APPENDIX B APPENDIX C APPENDIX D APPENDIX E APPENDIX F APPENDIX H APPENDIX I APPENDIX J NHS INFORMATION STANDARDS BOARD SUBMISSION Page 3 of 45

4 NHS INFORMATION STANDARDS BOARD Bar Codes - Requirement for a Fundamental Information Standard Preface For the purposes of introduction and explanation, the Developers have introduced this Preface to help the Reviewers and ISB members understand the nature of this document and the one that will follow it, namely the RFID Requirement for a Fundamental Information Standard. We recognise that this departs from the normal standard template for a Fundamental Requirement document. This document describes the requirement for Bar Codes as a Fundamental Information Standard as will the following one but for RFID: both of them further define the two types of Data Carrier standards to be deployed by the NHS, the Framework Standard for which just having been agreed by ISB. For purposes of understanding what is by nature a technical and complex subject, we feel it may be helpful to envision Bar Codes and RFID (Radio Frequency IDentification) tags as simply two ways by which data can be carried (or symbolised) that is, two types of Data Carrier. Essentially, whilst they have differing characteristics which offer the User advantages and disadvantages dependent upon the application deployed, they are serving the same purpose and thus much of the content of each submissions will be common. Notwithstanding, the Developers have tried to ensure that this submission makes as much specific reference to Bar Codes as possible, as will the RFID submission for RFID so as to highlight the differences between these two types of Data Carrier. 1. Standard Demographics 1.1. Name of Standard Bar Codes standard for the purposes of Automatic Identification and Data Capture (AIDC). The GS1 Standards, and specifically the Bar Codes Data standard, is a foundational enabler of AIDC Sponsors Dr Helen Lovell Early Action Team Department of Health Richmond House Whitehall London 1.3. Developers Dr Mark Ferrar NHS Connecting for Health 2 nd Floor Princes Exchange Aire Street Leeds West Yorkshire LS1 4HY NHS INFORMATION STANDARDS BOARD SUBMISSION Page 4 of 45

5 Developed in conjunction with GS1 UK Staple Court 11 Staple Inn Buildings London WC1V 7QH GS1 UK is a Membership Organisation of GS1, a global, not-for-profit, membership organisation dedicated to the development and support of supply chain standards Commercial Issues The GS1 Standards are owned by GS1, a global, not-for-profit membership organisation whose mission is to develop and support information standards for the improvement of efficiency and effectiveness of members supply chains. GS1 consists of 108 Member Organisations representing 150 countries globally. The GS1 Standards, in use for the past 30 years, are used in multiple sectors worldwide and support in excess of 6 billion business transactions every day. The UK Member Organisation of GS1 is GS1 UK. The company prefixes (prefix of the identifiers) procured by NHS CFH under the GS1 UK / NHS CFH Agreement form the root of all the identification numbers to be deployed by the NHS. The Agreement gives licence of use of the GS1 Standards, including the Bar Codes, to NHS organisations. No other GS1 UK licences are required for Bar Code deployment in the NHS. Licences are renewable annually. The Bar Codes standard is totally complementary, and inextricably linked, to the Organisational Numbers standard, which is subject to a separate ISB submission. As a membership organisation, GS1 UK s future price increases need to be agreed by the GS1 UK Supervisory Board, who have a fiduciary duty to represent the interests of the members. There are terms in the contract with NHS CFH that restrict price increases on various elements of the arrangement to no greater than RPI + 1%. There is also a termination option. No organisation can have IPR on numbers and GS1 is no exception. GS1 s rights only extend to numbers that are claimed to be GS1 numbers. (For the sake of completeness the same applies to alphabetic codes and alphanumeric codes.) As soon as a number is put into a bar code carrier that is not recognised by GS1, it ceases to be a GS1 number and the user can do whatever he or she wants: the application is then beyond GS1 jurisdiction. Obviously there are risks in doing this because uniqueness is no longer guaranteed: anyone could put any data in these non-standard carriers. It follows that if a user puts non-gs1 data into a GS1 bar code carrier then they are pretending the data is standard GS1 data and thus infringing GS1 rights. We are sure the NHS recognise the crucial importance of working with official GS1 numbers and abiding by the rules. To do otherwise would risk mistakes in identifying items, locations or people that could have very serious consequences. The NHS should stress to their trading partners that conformance is (literally) vital. If the Supplier wishes to use GS1 standards (or if the NHS requires the supplier to use GS1 standards) then the supplier will need to join the GS1 community, if it is not already a member. The standard joining fees current at the time will apply. Use of GS1 standard Bar Codes in healthcare has been adopted by many authorities and regulatory bodies around the world. These are summarised in Appendix C. In terms of the size of the organisation, the widespread use of the standards and the extent and range of the supporting services available to users, GS1 and the GS1 Standards have no equivalence globally. GS1 has control of the GS1 Standards, elements of which are recognised by ISO Customer Need The case for the adoption of Bar Codes within the NHS is overwhelming. For example: NHS INFORMATION STANDARDS BOARD SUBMISSION Page 5 of 45

6 In medicines management, the use of robotic dispensing systems has been shown to reduce dispensing errors significantly (from 2.7% to 0.9% at the Charing Cross Hospital in London) which in turn will reduce the number of medication errors. In management of vaccines inclusion of a batch number and expiry date within a bar code placed on vaccine products linked to patient records has been shown in Canadian pilots to significantly reduce immunisation errors, increase provider s confidence in the record accuracy from 76% to 92%, and provided a time saving of an average 11 seconds per immunisation. Using Bar Codes to manage stock control, as in Leeds, bureaucracy is reduced and the supply chain becomes much more efficient, enabling staff and other resources to be redeployed elsewhere. More generally, the development of traceability through using Bar Codes (e.g. Data Matrix) will enhance the fight against counterfeits. Figures released by ScanTrack, suppliers of a widely used surgical instrument management system (reference Surgical Instrument Tracking adopter project), suggest the benefits related to the implementation of its system where bar coding is used to uniquely identify the instrument trays as well as the instruments themselves (Data Matrix bar code), are: 20-30% reduction in instrument repair and replacement costs; 50% reduction in the incidence of missing or incorrect instruments; 30-60% reduction in the training time of new staff; Financial Impact of cancelled procedures (14 procedures per month) due to non-availability of equipment, patient, instrumentation or theatre ( avg.) = 390,600 p.a. 50% reduction in asset dependent procedures valued at 195,000 p.a. 40% reduction in new instrument purchases 15% p.a. increase in theatre utilisation 20% p.a. reduction in consumables purchases Note that these figures are clearly dependent upon the size of the instrument sterilisation process and the number of the instruments involved but they do serve to illustrate the potential to be gained by the NHS of bar coding systems. Note too that the costs of implementing such a system would be considerable (several hundred thousand pounds). Further benefits have been identified in the following areas: Prevention in medicines administration error, currently estimated to result in 10,000 deaths per annum in the NHS. The potential to automate the recording of therapeutic interventions and equipment into electronic patient records. The release of clinical resources as a by-product of process efficiency gains. Some of the benefits that other industry sectors have derived from the implementation of Bar Codes include: Improved inventory management. Reduced supply chain shrinkage. Reduction in inventory capital. Improved service quality. Improved customer service. Improved recall procedures. See Appendix F for further AIDC examples and the resultant benefits. Standards for Data Carriers, Bar Codes and RFID, are central to effective AIDC implementation and both will be required by the NHS dependent upon the nature of the application to be deployed. In short, both types of Data Carrier have differing characteristics and as such offer different advantages and disadvantages. Bar codes, for example, require line of sight, near proximity scanning not touching, but reading within two or three inches of the bar code (light pen readers) or larger distances, up to a few tens of metres, with laser or camera focussed readers. They are relatively low cost (light pen readers particularly so), durable (depending on the material upon which they are applied and the type of bar code used) and can offer human-readability for content back-up purposes. Examples of use may include identification of inhospital packaged medicines (EAN 13) or marking of surgical instruments for tracking purposes (Data Matrix). NHS INFORMATION STANDARDS BOARD SUBMISSION Page 6 of 45

7 On the other hand, RFID can offer at-distance readability (say up to 3 metres dependent on type of RFID tag used), do not require line of sight, and can store data in a proactive sense. These characteristics offer definite benefits in certain applications such as on patient wristbands where the patient can be identified without necessarily disturbing him/her, or for asset movement tracking - beds moving between departments, for example. However, reading an RFID tag may present difficulties where certain metals or liquids are in close proximity, do not offer human-readability and, compared to bar codes, they are relatively expensive. The Developers envisage that the large majority of user applications in the short to medium term will require bar code implementations as opposed to RFID, as the latter technology is emerging and currently carries certain additional risks and costs dependent upon the application deployed. However, these downsides will inevitably reduce as the technology advances and production costs decrease, at which point bar code or RFID adoption will become, to a large extent, interchangeable. In fact, we can envisage certain Trusts/Users adopting bar codes as the data carrier and others RFID for the same application. The type of Data Carrier Bar code and/or RFID tag to be used in any single application will be identified in the relevant Operational Instantiation. Two of the early adopter projects Surgical Instrument Tracking and In-house Manufactured/Repackaged Medicines - will require bar codes (Data Matrix and EAN 13 respectively). POLICY GUIDANCE Coding for Success: Simple technology for safer patient care was published on 16 February 2007, and recommends that the GS1 System of standards is adopted by all NHS organisations wishing to use auto-identification. A summary document of Coding for Success is attached in a document entitled COI-Coding for_success.pdf. 2 Purpose and Scope 2.1 Standard Overview The effective implementation of AIDC requires the use of information standards for the unique identification of the care chain entities involved in the process and information carriers e.g. bar codes, which can be read / scanned for automatic data capture purposes. This ISB submission is driven by the requirement to ratify these Bar Codes to enable AIDC. A central component of the AIDC standards is the identification numbering system to ensure both global uniqueness of each instance of identification and the flexibility of use across a variety of applications e.g. locations, products, people (patients and staff), assets. This identification numbering system is symbolised via the use of the Bar Codes. The GS1 Standards include a range of Bar Codes each supporting different information carrying and physical characteristics to be used in accordance with the application of use. Examples include EAN 13, GS1-128, GS1 DataBar and Data Matrix, the usage of which will be in accordance with the application deployed and defined in the related operational standard. An important point to note is that the GS1 system enables the same identification numbers to be carried in bar codes and RFID tags. The enables the two carriers to co-exist and allows a migration from one to the other over a period of time. The Bar Codes standard consists of a variety of different symbologies which will be applied as fits the needs of the applications to be deployed (as Operational Instantiations). Those likely to be required by the NHS are described in Appendix A. 2.2 Purpose The over-riding purpose for Bar Codes as a fundamental standard for the NHS are their role as a foundational enabler of AIDC. The intention is that operational standards will be developed to provide more detailed guidance on specific applications of auto-identification and how the Bar Codes will be deployed for each one. Examples of use of the GS1 Standard Bar Codes include but are not limited to: NHS INFORMATION STANDARDS BOARD SUBMISSION Page 7 of 45

8 Manufactured products repackaged products, products manufactured in the pharmacy or laboratory, using EAN 13 for product identification. Vaccines for traceability applications, perhaps using a Data Matrix bar code including product code, serial number, batch number and expiry date. Surgical instruments for traceability purposes as part of the sterilisation process through decontamination centres, using a Data Matrix bar code. Locations for the identification of Trusts, hospitals, departments, Loan Stores, identified in an GS1-128 bar code, for example. 2.3 Scope Operational Information Standards supported by this Fundamental Standard There are many potential applications for the use of Bar Codes in the NHS which will require different types to be adopted. Accordingly, there is a wide range of operational standards that will be developed, and prioritisation here is required. Some applications will only bring significant benefits when the wider National Programme for IT (NHS CFH) programme is at a later stage (e.g. when all trusts have full electronic patient records). Early priorities are likely to include: Decontamination super-centres using the Data Matrix bar code on the instrument or instrument tray. Hospital manufactured medicines using the EAN 13 to identify the product. Vaccine tracking using Data Matrix containing the tracking data Back office functions such as stock control & supply chain efficiencies using Data Matrix codes to identify the product as well as batch number and expiry date Improve product recall procedures using Data Matrix tracking data including product code, serial number, batch number and expiry date. It is worth noting here that certain bar codes (e.g. EAN 13) support both machine readable and human readable data content which is an important characteristic in the context of risk reduction and with it improvement in patient safety. For information, and to further clarify the advantages of RFID tags over Bar codes in certain environments, we envisage tags will be used in the patient identification programme (imbedded in the patients wristband) as in certain cases, where for example the patient s wrist is under the sheets of a bed, line of sight may not be possible when reading the tag. This will be an early application for adoption What will the proposed standard be used for? Bar Codes will be used in many AIDC applications in the NHS, the majority of which are yet to be identified. Examples of early adopter applications for Bar Codes are: Surgical instrument tracking based on the Data Matrix bar code where tracking data including product code, serial number, batch number and expiry date are requirements; The identification of in-house manufactured or repackaged medicines, using an EAN 13 to identify the product code. Others to be fully described and scoped could include: Identification and tracking of vaccines based on Data Matrix bar code carrying product code, serial number, expiry date and batch number as the dataset; Identification and tracking of laboratory test results based on Data Matrix bar code carrying product code, serial number, expiry date and batch number as the dataset. See Appendix F for a full description of case study examples of the use of Bar Codes Who is the subject? NHS INFORMATION STANDARDS BOARD SUBMISSION Page 8 of 45

9 Subjects will be patients or other persons who come into contact with the NHS (e.g. bar coding the NHS Number), clinicians, medicines, devices, instruments, vaccines, locations (e.g. trusts, hospitals, departments, loan stores) assets, services and processes Who will use it? As previously stated, the Developers envisage that, for the medium term at least, the majority of NHS users of AIDC will wish to deploy bar codes (as opposed to RFID) and therefore the list of bar code end users will be wide ranging. For example: NHS Trust and regional decontamination centres NHS Trust pharmaceutical manufacturing and re-packaging services Hospital pharmacies GP practices LSP deployed systems for medication management NHS Screening Programmes Dispensing robots Practicing clinicians Other users are identified in the case studies in Appendix F How will it be used in routine existing working practices? The use of bar codes in the NHS are likely to change routine working practices but generally in a beneficial way. For example, by scanning bar codes on products (goods receipting or ward stock management) product data can be collected automatically thus removing the current routine practice of a manual counting process. We would anticipate that in the majority of instances process changes enabled by bar codes will make tasks simpler and more efficient as well as safer. The extent and manner of the changes will be dependent upon the nature of the application deployed but will generally involve the use of scanning equipment to read the bar codes or of printing technology to print them. For example: by scanning the patients wristband (reference the NPSA s Right patient right care and the associated Safer Practice Notice) and the medication about to be administered, any confusion regarding right patient (identified by the number in the wristband) or right product (as symbolised by the number in the in the bar code) can be avoided by automatic reference to the electronic care record. A more complex example would be that for Surgical Instrument Tracking (one of the adopter projects). By bar coding each surgical instrument with a unique number (with the Data Matrix bar code) and associating the instruments with the instrument tray, itself uniquely marked, the use of the instruments can be associated with an operating procedure event (which can also be given a unique number) and indeed the patient (identified via the wristband), with this information all recorded (automatically) within the patient s health care record. Clearly the automation of this complex process will include a lot of bar code scanning but remove many of the manual processes (and inaccuracies) routinely associated with surgical instrument management. Changes to routine working practices will be identified in the relevant Operational Instantiation Where will it be used? Potentially throughout the NHS, into Primary Care and the Community. Further detail is outlined in the case studies in Appendix F. Note that the draft NPfIT document Bar-coding the NHS Number to support the delivery of the NHS Care Record Service promotes the use of the GS1 Standards (see document version 01 Issue Date 16/03/04) as the data structure for the NHS Number and symbolised by an appropriate Bar Code. 2.4 Out of Scope NHS INFORMATION STANDARDS BOARD SUBMISSION Page 9 of 45

10 Recognised as out of scope is the symbolisation of the following codes: The ISBT code for blood units (which can safely continue to use its established AIDC standard) The SNOMED code as implemented in the dm+d, (although there is an intention to map the GS1 Standard product identifier (Global Traded Item Number or GTIN) into the dm+d, as a complementary data element to the SNOMED code) Codes adopted as part of the HL7 standards implementations Applications where there is a fundamental regulated need not to use the GS1 standard Codes allocated by organisations external to the NHS that already use AIDC technology. It is believed that incompatibility issues will not arise as these applications are likely to be operated in a way that stands-alone and subject to their own operational procedures. Note, however, that bar code readers can usually be dual-programmable to manage a multiple bar code standard environment e.g. the ISBT code for blood units and GS1 standards for laboratory test results. These out of scope applications, and others not using GS1 standard Bar Codes, require regular review and discussion; they should be logged and their development monitored. If, over time, it is apparent that they should migrate to GS1 Bar Codes, then migration issues will be identified in the related Operational Instantiation and the log updated accordingly. 2.5 Performance Characteristics The key performance indicators which will be built into the early adopter projects are: 1. Increase patient safety 2. Reduce cost 3. Improvement on staff job role (increasing time with patients) 4. Provision of project staff support within the early adopter organisation 5. Time required for early results to be delivered 6. Cost/benefit of the early adopter projects 7. Opportunity for AIDC growth within the early adopter organisation, including rolling in BAU. Feedback on how these will be managed will be included in each adopter project substantiation. The measurement processes for the above will be dependent upon the application deployed and its environmental characteristics but are likely to be built around before case and after case measurement. For example, one of the key benefits of the In-house Pharma Manufacturing / Re-Packaging project is the enablement (via reading the EAN 13 code) of downstream robotics at the pharmacy for inventory management where the time saved (and accuracy) in the stock put-away process can be readily measured. There are many case study examples of the benefits of inventory management by robotics and these can be applied to in-house or repackaged products to further substantiate the business case. 3 Business Justification 3.1 Strategic Fit Criteria under which the proposed information standard is submitted The Bar Codes standard is part of the delivery of an agreed national programme of work undertaken by NPfIT involving the use of AIDC. This is confirmed by the Technology Statement included as Appendix C and Sponsor Statement in Appendix J Business justification Fits under the given strategic fit criteria When is the NHS required to adhere to the proposed information by? We recommend that as soon as this Requirement submission is ratified by ISB, the use of bar codes to GS1 standards is mandated for all new bar code applications that are in the scope of this submission. The related Operational Instantiation will define the timescales for adoption. NHS INFORMATION STANDARDS BOARD SUBMISSION Page 10 of 45

11 A DSCN will be raised to mandate the use of GS1 standard Bar Codes when this submission is confirmed as a Fundamental Standard. Timescales for this are expected to be March Review of Central Returns (ROCR) Submission Plan We do not consider that adoption of the standard for bar coding imposes any additional burden on NHS Organisations, insofar as the adoption of Auto ID technologies remains with individual organisations. In any event, even if bar coding in an area related to the production of statistical analysis, the adoption of Auto ID should enable a decrease in burden in terms of data collection, not the reverse. 3.2 Relationship to the National Programme for IT (NPfIT) This submission is fully supported by the National Programme for IT. A statement of such support is included in Appendix C. 3.3 Operational Fit Concept of Operation The GS1 system comprises of three distinct components: Unique identifiers, formed by the Company Prefixes procured by NHS CFH Standard bar codes (or radio frequency tags carrying GS1 identifiers), the Bar Codes for automatic data capture Messaging standards for electronic data interchange (EDI) and Data Synchronisation between trading partners The purchase of the Identification Numbers by NHS CFH gives license of use of the other components of the GS1 Standards e.g. bar codes, to NHS users. Their fitness of purpose will be confirmed by way of the early adopter projects. These components are further discussed in Appendix G Identification and bar coding GS1 Unique Identifiers The unique numbers will be used to uniquely identify products, assets, locations, service relationships and logistics units. Each user/organisation is assigned one or more unique company prefix(es) which will become the root of identifiers they can apply. The method of allocation (of the prefixes) will be agreed by GS1 UK and NHS CFH under the terms of the procurement Agreement between the two parties. The construct of the identifier (and there are several types of identifier within the GS1 standards) can and will vary according to its application. For example, NHS locations will be identified by the use of the Global Location Number (GLN) ; NHS manufactured products and services by the GTIN (Global Trade Item Number); and patients or staff by the GSRN (Global Service Relationship Number). An Identifier should have no meaning but used simply as a key to computer held files storing the required application data. Each company prefix number as issued by GS1 UK will be unique. Implementation rules governing the use of the standard in healthcare require that identifiers are never reallocated or reused, ensuring their uniqueness in perpetuity. NHS use of company prefixes is subject to a separate ISB submission referred to as Organisational Numbers standard for AIDC. Note: full meanings and descriptions of GS1 identifiers are included within the GS1 General Specifications Bar coding NHS INFORMATION STANDARDS BOARD SUBMISSION Page 11 of 45

12 The GS1 Standards consist of a number of different forms of Bar Code each with different levels of functionality. For example, the EAN 13 (commonly seen on OTC pharmaceutical products and patient packs delivered to hospital pharmacies) simply carry the item s product number (typically 13 digits). On the other hand, certain applications will require additional data elements to be scanned and automatically captured and these will require the use of more functionally rich bar codes. For example, the surgical instrument tracking application will need not only product code recorded but a unique serial number (identifying each single instance of an instrument) and use, say, the Data Matrix code etched into the instrument to do this. Other applications will require batch number and expiry date perhaps requiring the use of different bar codes. The type of GS1 standard bar code to be deployed will be specified as part of the Operational Instantiation standard for the application. The purchase of the Identification Numbers by NHS CFH gives license of use of the other components of the GS1 Standards e.g. bar codes, to NHS users. Their fitness of purpose will be confirmed by way of the early adopter projects. NHS use of bar codes is subject to this ISB submission referred to as the Bar Codes standard for AIDC. Note: full meanings and descriptions of GS1 bar codes are included within the GS1 General Specifications. 3.4 Impact and Implications Implications to stakeholders Implications to stakeholders will be many and diverse dependent upon the application deployed although they will only apply when numbers have been allocated within the NHS and Bar Codes adopted to carry them. The key implication will be the positive impact of Bar Codes on patient safety (see 4.7). Further implications will range from change of working practices (as scanning is introduced), and the reduction of paperwork to improved traceability and inventory management systems. As already acknowledged in this submission, whilst there are many bar code applications currently in use in the NHS they are relatively small in number when compared to the potential use. Whilst the total number is unknown, the Developers believe that they are limited to certain common applications used by NHS Trusts such as ward-based inventory management systems, identification of the patient s record card and surgical instrument tray marking. As the majority will not currently be based on GS1 standard bar codes, the implications to stakeholders are likely to be changes to routine working practices if and when these applications migrate to GS1 bar codes. This may be necessary in order to maintain the systems quality. Any implications, such as re-training and use of different scanning equipment, will be identified in the related Operational Instantiation. Non GS1 bar code systems should be identified and logged in order that their development can be tracked. There are many benefits related to the use of bar codes and some of these have already been described in Section 1.5. Further benefits are included in Appendix F Analysis of replacement of existing standards The standard is not replacing any existing standard but will make choice more obvious. Regardless, replacement will not apply for bar codes not allocated by the NHS. Currently there is no recommended standard for bar codes in place in the NHS - where bar code applications have been deployed, either proprietary standards have been adopted or GS1 standard bar codes are already in use. Whilst it is very difficult (or effectively impossible) to confirm the actual number of bar code applications deployed in the NHS, they are relatively low in number when compared to the potential. Notwithstanding, in some applications such as ward-based inventory management, identification of patient record cards and surgical instrument tray marking the use of bar codes is relatively high and it is in these applications where replacement and migration to GS1 standards will be a key consideration for the related Operational NHS INFORMATION STANDARDS BOARD SUBMISSION Page 12 of 45

13 Instantiations. These will identify any migration or replacement issues arising. If for any reason migration is not possible, the non-gs1 applications log (as described in above) will need updating. Where there is a requirement to use a mix of bar code standards - GS1 or non GS1 - in any one single application e.g. blood transfusion units where the blood bag uses one standard (ISBT-128) whereas the lab orders and samples system uses a GS1 standard (e.g. Data Matrix or EAN 13), the bar code reader involved in the scanning process will need to be programmed according to the type of bar code read. In some instances, this may require separate scanning equipment but usually the scanner will support the ability to be automatically multi-programmable. 3.5 Known Standards Existing standards with a related purpose and scope There are currently eight internationally recognised auto-identification standards referenced by the International Organisation for Standardisation (ISO). They are: HIBC (or Code 39) - Interleaved 2 of Code PDF MaxiCode - Data Matrix - QR Code - as well as GS1 standards - These standards comprise a combination of symbologies only (i.e. the printed entity that allows machines to read the coded data it represents) and symbologies plus coding schemes (i.e. those that define both the printed entity and the format of the code that is represented by it). Note: Data Matrix bar codes, which we anticipate will have increasing use in the NHS, are part of the GS1 Standards. The non-gs1 Bar Codes may currently be in use in the NHS and, if applicable, may migrate to GS1 standard Bar Codes over time, GS1 standard Bar Codes being the preferred standard. This proposal does not restrict the use of non-gs1 standards to the NHS suppliers community although again GS1 standard Bar Codes will be recommended to suppliers when trading with the NHS (see also the PaSA Letter of Support in Appendix I) Assessment to include or eliminate In the commodities market the GS1 suite of standards hold a strong global presence: 1.3 million global organisational members with in excess of 6 billion transactions per day in 129 countries. The bar code standard employed by the retail sector and familiar to everyone in the UK through electronic point of sale (EPOS) systems is GS1 based. Within healthcare research by the NHS Purchasing and Supplies Agency (NHS PASA) has identified the following: 80% of pharmaceutical suppliers use or plan to use auto identification technology in their operation. Of these, 92% use the EAN 13 standard from the GS1 suite. 51% of non pharmaceutical suppliers, both healthcare and non-healthcare related, use or plan to use auto identification technology. Of these 74% use the GS1 suite, primarily EAN 13 with smaller use of GS The PASA analysis concluded that the GS1 Standards have no global equivalence and recommends its adoption for all products from all suppliers. For more detail of the NHS PASA s Position Statement on Automatic Identification for products sold to and used by the English NHS, version 0.6, dated 5 October 2004, see Appendix E. NHS INFORMATION STANDARDS BOARD SUBMISSION Page 13 of 45

14 3.6 Interdependencies Bar Codes Requirement for a Fundamental Information Standard Existing or planned standards The draft NPfIT proposal Bar coding the NHS Number (see draft Version 01, dated 16/03/04) proposes the use of the GS1 standards. Whilst it is not yet a full NHS Standard, when approval has been successful, this application will become an interdependency on GS1 Standards becoming a fundamental standard. The Organisation Numbers standard, which is symbiotic with this Bar Codes submission, has achieved acceptance at the Requirement stage. Draft and Full submissions are planned for the next few months Projects, programmes or organisations This work has interdependencies with: National Strategic Tracing Service (NSTS) Health Record and Communication Practice Standards for Team Based Care (ISB, 7 December 2004) Date Display for clinical systems within NHS in England The NHS Numbers for Babies (NN4B) service is part of NSTS. 3.7 Consultation and Support The Department of Health policy document Coding for Success, published in February 2007, described the GS1 standards for bar coding as the way forward for AIDC adoption in the NHS. NHS PASA recommend that all supplies to the English NHS should have a product code symbolised by a bar code following the GS1 standard format, and recommends that all manufacturers of medicinal products and medical devices adopt this approach Right patient right blood a SPN (safer practice notice) recommending both high and low tech solutions to making blood sampling and transfusions safer (November 2006) Safer patient identifiers to be used on identity bands a standard for the NHS in England currently being developed to draft standard by the NPSA for the Information Standards Board (Spring 2007). 4 Development and Implementation 4.1 Standard Lifecycle Requirement stage for this Fundamental standard is submission to ISB in December 2007 in conjunction with the Data Carriers Framework standard submission in the same timescales. Additionally these submissions will be supported by a Fundamental standard submission for RFID data carriers in the same timescales. Strategy and timescales for Draft and Full submissions are yet to be defined. Deployment of the Bar Codes in the field will be defined by Operational Instantiation standards for each application which will describe in detail how a specific Bar code(s) is used including the data set supported. These will be developed on an as required basis it is currently planned that the early ones will cover Surgical Instrument tracking, Pharmaceutical Product Manufacturing/Re-packaging and Patient Identification, to be submitted to the ISB process in the first half of Provisional Testing Approach As discussed above, the project has identified three early adopter applications (Surgical Instrument tracking, Pharmaceutical Product Manufacturing/Re-packaging and Patient Identification) which will form the basis of trials to confirm the Bar Codes standard are fit for purpose. The result of these trials will help to determine the benefits and their delivery, priorities for delivery, associated standards in the NHS and will begin to assimilate a community of best practice with regards wider service deployment. The testing philosophy will be to keep the first projects compact and focused in order to take initial learning experiences through to the second phase projects which will be broader in application of use. See also Appendix H. NHS INFORMATION STANDARDS BOARD SUBMISSION Page 14 of 45

15 4.3 Implementation Plans Bar Codes Requirement for a Fundamental Information Standard The Department of Health implementation plan described in Coding for Success describes the following timetable for 2007: March GS1 UK and NHS CFH central support available (completed) May 2007 demonstrator projects announced and begin (projects identified and application guidelines (to support the Operational Instantiation standards) See also Appendix H. 4.4 Governance Issues Guidelines concerning the issue of identifiers are under the control of the NHS CFH. Information governance arrangements will be relevant at the application level as Bar Coding projects are deployed these will be described in the related Operational Instantiation and governance procedures put in place accordingly. The GS1 Standards are owned and governed by GS1. GS1 is a global not-for-profit membership organisation governed by its members with a management board (elected by the members to act on their behalf) composed of key leaders and drivers from multi-nationals, retailers, manufacturers and GS1 Member Organisations. As a result, the GS1 management board has a global, multi-sectoral constituency. GSMP, the Global Standards Management Process, is the change control process used by GS1 to ensure new standards and amendments to existing standards can be introduced in a controlled manner to meet users requirements. HUG, the Healthcare User Group, consists of the major global medical device and pharmaceutical manufacturers have exclusively endorsed the GS1 Standards as being the standards for the healthcare sector globally. The work of the HUG is facilitated by GS1 and forms the authoritative input to the GSMP for requirements for the healthcare sector. The Department of Health is working closely with HUG. There are a number of risks and issues associated with use of the standards but all of these are very small when compared to the potential benefits. General examples of risk include: Inability to accurately read a bar code Invalid, incomplete or inaccurate data contained within the bar code Failure of the correct process being undertaken in the bar code application Incorrect data being carried within the bar code Additionally there will be risks specific to the application itself and these will of course vary according to its nature and extent. The risks for each use case of the standards - and their mitigation - will be described in the related Operational Instantiation. 4.5 Migration Issues There are many examples of the use of bar coding in the NHS, typically based on non GS1 bar code standards. However, the number of applications involved are relatively small, usage being largely confined to applications commonly adopted in various Trusts. Examples of these are ward-based inventory management, identification of patient record cards and the marking of surgical instrument trays. Clearly there will be opportunities for the migration of these to GS1 bar codes and issues will inevitably result. However it will be important in these instances to examine the potential benefits of migration (the cost versus benefit case) and the decision to migrate or not taken accordingly. Examples of the criteria for such an examination include: Will the quality of the bar coding application be enhanced and if so by what value? Will migration improve patient safety? What would be the cost of migration in terms of, for example, the necessary re-training of staff, provision of new equipment and changes to the application system? These and others related to the application will be considered in the related Operational Instantiation. NHS INFORMATION STANDARDS BOARD SUBMISSION Page 15 of 45

16 Notwithstanding, as the majority of potential bar coding projects in the NHS are currently not bar code enabled it follows that for these applications the majority - migration issues will not arise.. See also section An important point to note is that the GS1 system enables the same identification numbers to be carried in bar codes and RFID tags. The enables the two carriers to co-exist and allows a migration from one to the other over a period of time. 4.6 Costs and Funding There are various elements of costs associated with the deployment of any application of bar coding. For example: Application development cost of the end-to-end system in which bar coding is used (NB bar codes are an enabler of solutions and not solutions in themselves); Costs of printing / applying the bar codes on packaging or similar materials; Bar code scanning / reading equipment and related software; User training and user related documentation Migration costs (if applicable) We should make the point that the costs of the bar coding equipment needed are relatively low a scanner for example can be purchased for as little as and a printer (if required) for little more. Bar code production is typically low cost although more complex bar codes such as Data Matrix will be higher. The real cost of a bar coding application will be in the end to end system itself and this will depend on its nature, functionality and complexity. We anticipate the bulk purchasing power of the NHS can reduce related equipment and software costs significantly. Note: there are no incremental licensing costs associated with the use of the GS1 standard Bar Codes these have been covered in the Fundamental Requirement submission for Organisational Numbers, already agreed by ISB Operational deployment costs It is very difficult, if not impossible, to identify in this submission any rule of thumb levels of cost for deployment of a particular application. These will be variable according to the needs of each application and dependent upon the nature of the application, the users involved, the equipment (e.g. scanners & printers) required and the process and application integration work required. Costs at this level of granularity will be estimated in each related Operational Instantiation. However, for guidance and by way of example, implementation costs for the bar coding of in-house manufactured medicines as collected from a recent survey conducted by the NHS National Auto-ID Pharmacy Production Board (published early November 2007) suggested: Software - 1,500 to 15,000 Hardware - 4,000 to 25,000 Personnel time to 1,000 Experiences gained through the early adopter projects, one of which will be the above referenced application, will provide important feedback to better quantify levels of cost per each type of application deployed. This will provide further evidence of costs for the draft and full submissions of this ISB submission. As a general point, it may well be in some circumstances that the cost to benefit case cannot be made and alternative approaches to enabling the application may be applicable Funding Funding for the current year has been secured within directorates of Technology Office within NHS CFH. NHS INFORMATION STANDARDS BOARD SUBMISSION Page 16 of 45

17 4.7 Safety Bar Codes Requirement for a Fundamental Information Standard Funding for development work will be secured through internal development project approval processes. Funding for future years will be subject to discussion and negotiation within and between NHS CFH and the NHS. The single most significant business driver for the adoption of bar coding in the NHS is the benefit to patient safety. The following has been extracted from the recently published Department of Health policy document Coding for Success:- (i) Reducing and where possible eliminating errors in the matching of patients with their care is central to improving patient safety in the NHS. Auto-identification and data capture (AIDC) technology can help achieve this goal. (ii) The National Patient Safety Agency (NPSA) in its study Right patient right care described three types of mis-matching error: A patient is given the wrong treatment as a result of a failure to match him or her correctly with samples, specimens or X-rays (e.g. Mrs Johns blood sample is confused with Mrs Jones, leading to incorrect diagnosis and treatment of both patients); A patient is given the wrong treatment as a result of the failure of communication between staff, or staff not performing checking procedures correctly (e.g. wrong kidney removed ); and A patient is given treatment intended for another patient as a result of failure to identify him or her correctly (e.g. Mr U Patel receives the medication for Mr V Patel). (iii) There are no accurate figures on the frequency or cost of such mismatching errors, but they form a significant part of the whole range of errors in healthcare. It has been calculated that: In the UK about 10% of inpatient episodes result in errors of some kind, of which about half are preventable; and Of 8 million admissions to hospital in England each year, about 850,000 result in patient safety incidents which cost the NHS about 2 billion in extra hospital days. Note that bar coding is an enabler of an application and not a solution in itself it needs to be deployed within the application which is responsible for delivering the solution. Whilst bar coding can generally be relied upon, clearly there are risks associated with the application s deployment which will usually include end to end audit trails. These will only be as reliable as the accuracy of the data presented to them permits (garbage in, garbage out). Excluding the risks of the related application (out of scope of this submission), risks introduced by the use of bar codes could include: Failure to accurately read a bar code; Lack of quality of printing the bar code leading to read inaccuracies; Loss or corruption of data during the read / scanning process Loss or failure of equipment related to the bar coding process The related Operational Instantiation will identify bar coding risks for the application and describe procedures to mitigate against them. 4.8 Maintenance The Global Standards Management Process, or GSMP, is the pre-eminent worldwide collaborative forum where GS1 standards are built and maintained. Since it was created in 2002, the GSMP has been the engine that powers the entire GS1 System of standards. It is an open and transparent process made possible by the participation of companies who wish to improve the efficiency of supply chains. The GSMP brings together users from all industries and from everywhere in the world to identify needs for standards, gather business requirements, document best practices, obtain consensus on solutions, and then develop and implement the resulting supply chain standards. NHS INFORMATION STANDARDS BOARD SUBMISSION Page 17 of 45

18 In the event of a change to an existing standard, GSMP will identify a suitable timeframe for the user community to migrate to the revised standard. Such changes can impact a mass of users but typically do not cause disruption. The NHS CFH has procured membership to the GS1 organisation. As a consequence the NHS CFH is entitled to attend the GS1 HUG (Healthcare User Group) to ensure that the development of the standards are fit for purpose for the NHS CFH. The GS1 global HUG is established as a voluntary global group of GS1 members and invited supply chain participants, and all its business shall be conducted within the framework established by GS1 for such groups. HUG is the authoritative input to GSMP on healthcare matters. The DoH/NHS has a significant representation in HUG notably: Rachel Hodson-Gibbons (PaSA) as Co-Chair Helen Lovell (DoH) Neil Lawrence (CfH) Judie Finesilver (PaSA) Chris Ranger (NPSA) It is envisaged that if an individual moved out of DoH/NHS then their position would be filled by a replacement representative from an appropriate NHS department. 4.9 Conformance The early adopter projects, which are part of the draft phase of the ISB process, will inform conformance of the standard. The AIDC project manager will lead the early adopter phase and the key indicator of conformance is that items which are bar coded using the GS1 standard are correctly identified and the Bar Code correctly portrayed. The key success criteria will be the level of uptake of the numbers in the NHS Evaluation Successful evaluation of the criteria will depend on the listed key performance indicators. The Developers have added for each an example of how the use of bar codes benefit the criteria in order to help understanding: Increase patient safety by the ability to collect data by the automated scanning of the bar codes thus reducing the risk of human involvement and human error i.e. increasing the certainty of process; Reduce cost by reducing the time taken to undertake certain tasks, such as inventory receipting or medicine administration; Improvement on staff job role (increasing time with patients) exampled by the illustration immediately above where use of bar codes can benefit medicine administration thus saving nursing time; Additionally, the adopter projects will bring invaluable experience of use of bar codes at the project level not only to the users themselves but for those across the NHS. The following will also form part of the evaluation criteria: Provision of project staff support within the early adopter organisation Time required for early results to be delivered Cost/benefit of the early adopter projects Opportunity for bar coding growth within the early adopter organisation, including rolling in BAU. NHS INFORMATION STANDARDS BOARD SUBMISSION Page 18 of 45

19 APPENDIX A Bar Code Descriptions Introduction Bar codes help organisations to capture data automatically via scanners and readers. Automatic data capture is less error prone and faster than manual data capture with statistics indicating 1 error per 300 characters entered using a keyboard as opposed to 1 error per 1,000,000 for data entered through scanning of bar codes. A bar code language is referred to as a bar code symbology and is the structure used to construct patterns as per specifications. There are many bar code symbologies (languages) each with its own rules for character encodation, printing and decoding requirements, error checking etc. The GS1 System uses the following bar code symbologies which may be applicable to the NHS as defined by the Operational instantiations to be developed: 1 EAN/UPC symbology family (EAN 13, EAN-8, UPC-A and UPC-E) 2 ITF-14 3 GS Bar codes for very small items - DataBar (Formerly known as Reduced Space Symbology - Data Matrix Bar code symbology decision tree The following decision tree identifies which bar codes are most applicable to the application to be supported. NHS INFORMATION STANDARDS BOARD SUBMISSION Page 19 of 45

20 Yes Will the item be sold at the retail point of sale or stored in a robot No Is it a small item? Is extra information required? Yes No No Yes Is extra information No Is extra information required? Use EAN-13, ITF- 14, EAN-8, UCC/EAN-128, DataBar Use UCC/EAN- 128, DataBAr and composite Yes Is it a small item GTIN in EAN-13 Extra information in UCC/EAN-128 or composite NHS INFORMATION STANDARDS BOARD SUBMISSION Page 20 of 45