GS1 Company Prefix Governance

Transcription

1 GS1 Company Prefix Governance Executive Summary GS1 sets standards, using unique numbers or identifiers, for global use which makes the reliable identification of products, items and assets possible. The Department of Health Information Standards Board has adopted GS1 identifiers and bar codes as the standard to be used within NHS Trusts in England for a wide variety of applications including the tracking and identifying of; surgical, medical devices and records as well as the patients and staff themselves. This document has been compiled to provide guidance for NHS Trusts on how they manage the creation and maintenance of GS1 identifiers. All GS1 Identifiers start with a unique sequence of numbers, known as a GS1 Company Prefix and referred to here as a Prefix. GS1 UK will allocate unique Prefixes to each Trust. The use of the Prefix ensures that identifiers allocated by a Trust will be unique and traceable back to the source. It is essential that each Trust maintains control over who is entitled to use Prefixes to create GS1 identifiers within the Trust to ensure that there is no duplication. Any duplication could cause errors in patient records, inadequate medical device maintenance or even cause patients to receive the wrong medication. The control of GS1 identifiers can become complicated where Trusts merge or demerge and there are guidance notes included on how to approach this issue. This report recommends that each Trust nominates one individual who will be responsible for the management of Prefixes within their Trust. This individual will then decide on the best option for managing Prefixes of which GS1 UK has outlined three approaches Trusts may wish to consider: Managed departmentally Managed centrally by each Hospital Managed centrally by each Trust Once identifiers have been created for items and assets a record of these must be kept. Trusts may wish to consider using services provided by GS1 UK to manage asset information as it is not recommended that this data is kept locally on a PC or desktop.

2 1. Introduction GS1 UK Background GS1 sets standards, using unique numbers or identifiers, for global use which makes the reliable identification of products, items and assets possible. GS1 UK is one of 111 GS1 member organisations across 150 countries, and operates in multiple sectors and industries. The GS1 system enables items such as products, pallets and even patients to be uniquely identified. Today, GS1 standards are used by millions of companies in many different sectors including healthcare, food services, manufacturing and retail. Everything that we do, essentially, stems from a simple number. In the healthcare sector, by attributing a unique number or identifier, an item can be accurately identified in the supply chain, increasing patient safety and removing waste and errors from your processes. These GS1 identifiers remain the same regardless of whether they are carried in bar codes, RFID tags or electronic messages. In this way GS1 standards enable you to identify, capture, and share information on pharmaceuticals, medical devices, assets and returnable equipment automatically. 2. Context The Department of Health Information Standards Board has adopted GS1 identifiers and bar codes as the chosen standard to be used within NHS Trusts in England. (See ) The expectation is that these standards will be used for a wide variety of applications including: tracking surgical and medical devices identifying other assets medical records pharmacy inventory management bar coding of physical locations identification of patients and staff How does unique identification work? Any product, item or asset that you want to track or trace needs to be uniquely identified. The GS1 identifiers come in a variety of formats but the most important terms and identifiers you will need to be familiar with are as follows: A Global Trade Item Number or GTIN - used to identify products such as a drug or implant A Global Individual Asset Identifier or GIAI - used to identify assets such as surgical A Global Location Number or GLN - used to identify locations such as a hospital theatre or ward These different types of unique identifiers are then visually represented in bar code images that will appear on the items. All GS1 Identifiers, whether they are GTINs or GIAIs, start with a unique sequence of numbers known as a GS1 Company Prefix, referred to in this document as a Prefix. GS1 will allocate a Prefix to Trusts ensuring that each one is unique. The Trust can then generate its own GS1 identifiers based on its Prefix secure in the knowledge that these identifiers will be unique. There are different ways in which you can chose to manage your Prefix(s) depending on how your organisation is structured and operates its processes. This has been outlined in more detail in section 4 of this document. GS1 Company Prefix Governance 24 June 2014 Page 2 of 6

3 3. The Issue As GS1 standards become fully integrated across hospitals and Trusts it is critical that their integrity is not compromised and those managing GS1 standards have a full understanding of their role and responsibility. It is essential that each Trust maintains control over who is entitled to and responsible for the creation of GS1 identifiers to ensure that there is no duplication. Any duplication could cause errors in patient records, inadequate medical device maintenance or even cause patients to receive the wrong medication. This guidance document has been created to help address the following issues: 1. Correctly managing your Prefixes and Identifiers to ensure consistency and accuracy 2. How to manage GS1 Standards in the case of mergers and demergers 4. Recommendations 4.1 Managing your Prefixes 1. It is recommended that responsibility for managing all GS1 standards and related activity is given to one person within each Trust. In particular the person responsible needs to: Understand the GS1 System of Standards. There is a variety of GS1 UK training courses available ranging from online seminars to customised workshops. Please see the GS1 UK web site at or contact the GS1 Service Team on freephone for more information. Implement processes to control the creation of GS1 Identifiers to prevent duplication and to ensure conformance with GS1 guidelines. Maintain a central master list of Prefixes which have been allocated to the Trust by GS1 UK and record for each key information such as: - To which hospital or department within the Trust the Prefix has been allocated - Which types of GS1 identifier the Prefix has been used for Ensure that anyone then subsequently given the responsibility of creating GS1 identifiers within the Trust has been properly trained and is operating robust processes. Inform GS1 UK who within the Trust is authorised to request additional Prefixes or to return unused Prefixes. GS1 UK will only authorise actions from known individuals Ensure that those involved in creating and using GS1 identifiers understand the GS1 Standards and implementation guidelines as they apply to healthcare and as they are updated from time to time. 4.2 Options for Managing Prefixes Control over the creation of GS1 identifiers can be achieved through a centralised process or through a number of distributed processes. GS1 does not recommend one approach over another since it is recognised that the most appropriate form of control will vary with a Trust s size, management structure and IT capability. This section outlines various options and their strengths and cautions. Trusts may find that a combination of Trust, hospital and departmental systems is most appropriate. Option Strengths Considerations 4b.1. Prefixes allocated to and managed by selected departments Simple to administer Clear distributed responsibility for creation of GS1 identifiers No central systems required Relies on a variety of departmental processes to avoid duplication of identifiers; this may make it more difficult to ensure that processes are robust. No automated Trust or hospital log of all the identifiers that have been created GS1 Company Prefix Governance 24 June 2014 Page 3 of 6

4 Option Strengths Considerations 4b.2. Prefixes allocated to and managed centrally by each hospital Fits within existing hospital management structure Strong formal control of the identifier creation process Provides a hospital wide log of identifiers Requires creation of a centralised system for each hospital Relies on departments using the centralised system 4b.3. Prefixes allocated to and managed centrally by a Trust Fits within Trust management structure Very strong control of identifier creation process Trust wide log of identifiers Only requires a single Prefix per Trust Requires creation of a centralised system for the Trust Relies on hospitals and departments using the centralised system 4b.1. Prefixes allocated to and managed by selected departments Departments are given a block of GS1 identifier numbers that they can use as they require. This block could be a Prefix allocated directly by GS1 UK or could be a subset of a Prefix initially given to a Trust or Hospital as the master Prefix. The department must create a system for ensuring that the identifiers are created correctly with no duplication. This approach enables the creation of GS1 identifiers to be fully delegated to the departments that require them. If the Prefix block is allocated directly by GS1 UK then this ensures that the blocks are allocated correctly with no overlap and therefore minimises the likelihood that duplicate identifiers might be created. 4b.2. Prefixes allocated to and managed centrally by each hospital The hospital takes central control over all the Prefixes that can be used within the hospital to create GS1 identifiers. Departments needing a new GS1 identifier request one from a central hospital computer system. A manual system, although theoretically possible, is very unlikely to be able to respond quickly enough and would be prone to manual errors. This approach gives strong control over the creation of identifiers but unless the central system is fully integrated into departmental systems may lead to rekeying of the identifier into the local system which in turn will lead to errors. It has the disadvantage that each hospital needs to create its own central system. 4b.3. Prefixes allocated to and managed centrally by a Trust This approach is very similar to section 4b.2 but has the benefit that only one central system is required. However it may be more difficult to integrate the central system into each hospital's local systems and therefore be more likely to give rise to rekeying and associated errors. 4.3 Merging and de-merging When a hospital is merged into or demerged from a Trust it is essential that ownership of the licences to Prefixes and responsibility for managing them is made very clear. Prefixes must not be shared between Trusts. Responsibility for Prefixes that have been used to create GS1 identifiers must be negotiated and agreed. Only the Trust responsible for a Prefix may use it to create new identifiers. However existing identifiers can continue to be used by any Trust or hospital since the GS1 system ensures that these identifiers are unique and will not clash with identifiers in other hospitals. The responsibility for Prefixes should be documented in relevant contract documents and any changes should be notified to GS1 UK. For example suppose a Trust decides to use Prefix to create asset identifiers for all the medical devices in all the hospitals in the Trust. If one of the hospitals leaves the Trust that hospital will no longer be able to use the Prefix for any new medical devices it acquires. However their assets can continue to be identified by the existing asset identifiers since the GS1 system ensures that these identifiers are unique and will not clash with other identifiers in other hospitals. The hospital will, of course, need to use another Prefix for any new assets that it acquires. GS1 Company Prefix Governance 24 June 2014 Page 4 of 6

5 5. Managing your data The system that creates an identifier must record the details of when it was created, any relevant attributes and who it was created for. This information must be protected and backed up to ensure that the information is not deleted or changed; storing it locally on a PC is not recommended. Trusts may wish to use the GS1 UK My Numberbank and/or the TrueSource data pool to record their GTIN and GLN information. Alternative arrangements are required for recording other GS1 identifiers. 6. Appendix Example of Prefix Allocation Record Uptown Hospital Trust Prefix controller: Mr Clark The Prefix controller is responsible for maintaining the following record of what Prefixes are being used by whom and for what purpose. No Prefixes may be created or returned without confirmation from the Prefix controller. The following allocation of Prefixes is suitable for a hospital that does not have a centralised computer system for creating GS1 identifiers. Prefix Hospital GS1 Identifier Prefix GTIN Pharmacy Mr Cross Dept Name Purpose Location of list of identifiers Bar coding pharmacy products GIAI Medical Physics Mr Green Identification of medical devices e.g. pumps Prefix GTIN Mr Smith GIAI Mr Smith GLN Estates Mr Jones Identification of physical locations hospital wide + Trust wide GSRN HR Mrs Black Identification of staff Trust wide +Trust wide GDTI Medical records Miss Brown Bar code/rfid of medical records and forms Prefix Uptown GTIN Mr Blue Uptown GIAI Mr Blue Uptown GLN Estates Mr White Identification of physical locations hospital wide Prefix Uptown GTIN Pharmacy Mr Taylor Bar coding pharmacy products GS1 Company Prefix Governance 24 June 2014 Page 5 of 6

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