Submission to the Minster for Health and Children
Public Consultation on Proposed Health Information Bill
The Minister is proposing new legislation on the collection, use, sharing, storage, disclosure and transfer of personal health information as well as ensuring that the privacy of such information is appropriately respected
SUBMISSION BY GS1 [Global Standards 1(Ireland)) Limited]
(formerly EAN Ireland)
INTRODUCTION TO GS1
GS1 is a not for profit and neutral worldwide body comprising 109 Member Organisations (MO), dedicated to improving efficiency in the supply chain across the world by the adoption of Global Standards[1] for commerce. More than 5 billion daily transactions (bar code scans/electronic messages) are carried out by 1.3 million companies in over 150 countries using the GS1Standards.
Globally, GS1 has been at the forefront in supporting the development of efficient and cost effective solutions for traceability for both food distribution and healthcare. Many Healthcare Authorities, Healthcare Regulators, Healthcare Providers and companies providing supplies and services to the Healthcare Sector around the world have already adopted the GS1 Standards for identification purposes – patients, staff, products and services– both in medical device and pharmaceutical sectors. (c.f. Appendix 1 for more details.)
GS1 Ireland (the local GS1 MO office) was established in 1980 and has around 3,000 members in the Fast Moving Consumer Goods, Healthcare and other sectors. Our Board is representative of leading local and international companies including a wide cross-section of healthcare stakeholders who use GS1 Standards in their supply chains and for other mission critical operations.
GS1 Response:
GS1 Ireland welcomes the proposed Health Information Bill.
(a) We support the proposal to have unique identifiers for patients and health care providers which, when implemented along with an electronic health record and other technologies, will make a huge contribution in terms of the accuracy and security of diagnosis, treatment selection and the care delivery process. The result will be a vast improvement in the quality, efficiency and safety of individual treatment episodes coupled with considerable extra clinical benefits including the ability to automatically capture data for patient records and comparative analysis on patient outcomes versus treatment choices.
(b) The discussion document reflects careful consideration of key issues to be addressed if the transformational changes required are to be supported by patients and the other stakeholders involved. If digital records are to be shared between the various professional providers in the course of a patient’s treatment journey, then the privacy and security of these records must be fully secured.
In summary, GS1 believes that the adoption of GS1 Standards can assist in the realisation of the main objectives of the Health Information Bill, which are: -
· to establish a legislative framework to enable information –in whatever form- to be used to best effect to enhance medical care and patient safety throughout the health system;
· to facilitate the greater use of information technologies for better delivery of patient services; and
· to underpin an effective information governance structure for the health system generally
How can GS1 Standards help?
GS1 has over 30 years experience and knowledge of managing unique number banks and establishing the most widely used global standards by supply chain stakeholders in some 24 sectors including healthcare.
The GS1 Standards (see Appendix 2) today provide for:-
(a) Unique numbers for the identification of the following: -
· Patients and their individual treatment episodes;
· Healthcare providers (clinicians, nurses, pharmacists etc.);
· Products (medicines, medical implants, surgical instruments); and
· Services (medical procedures, lab tests etc.);
(b) Bar code and RFID standards for automatic identification and capture of patient, provider, product and other data (e.g. batch information and expiry data) using scanning technologies;
(c) Standards for secure exchange of information stored in distributed databases between trusted parties based on their particular rights of access - (EPCglobal Network);
(d) Secure e-Messaging standards for the communication of supply chain commercial and critical information;
(e) Using the Global Data Synchronisation Network GDSN, the exchange of product information for a wide variety of database applications i.e., supply chain, classification and clinical purposes;
Traceability standards have been developed in order to provide a basis for validating the effectiveness of solutions in the food and healthcare environment. Effective traceability reduces risk through certainty of identification of people, products, services and places and ensures tracking and tracing processes are operated in a timely manner.
Examples of Healthcare Solutions using GS1 Unique Numbers and Standards
(1) National Centre for Hereditary Coagulation Disorders (NCHCD)
The solution, approved and funded by the Department of Health and Children, was developed in response to the Lindsay Tribunal on the harm caused to Irish haemophilia patients due to the well documented failure to track and trace infected blood products.
This solution is a perfect example of the successful introduction of the GS1 Standards. Unique identifiers for patients, providers and products coupled with bar coding and an electronic patient record give real time visibility of all patient treatment episodes. The results have been dramatic in terms of patient safety, secure data exchange and patient satisfaction (100% per surveys). Each patient is uniquely identified by a GSRN (Global Service Relationship Number). Bar code scanning is used extensively to capture the unique identifiers and critical other data in real time. Manual recording and retention of paper records are no longer required, except for home treatment purposes. For the patient’s home or work, the use of mobile technology for the automatic data capture of treatment episodes has been fully tested. Homecare treatment accounts for more than 60% of the medication used for this patient group
The system provides for 100% product recall thanks to the GS1 unique identifier and serialisation of each patient pack within the barcode and the visibility of each storage location identified by a GS1 unique identifier. There has also been a marked improvement in the efficiency of clinical management procedures since the solution was rolled out.
The Haemophilia Electronic Patient Record also meets the aims of a national population health registry:
· 100% capture of cases (100% ascertainment)
· Prevents case duplication
· Can provide real time visibility of patient status including clinical data from home treatment episodes.
For more details see Appendix 3
(2) “Bar Coding for Success” – The Department of Health in the UK
In February 2007, the Department of Health issued their policy document “Bar Coding for Success” which promoted the strategy to adopt the GS1 standards as the information standard for the NHS in England. The policy is being rolled out now with NHS Connecting for Health working closely with GS1 UK to assist NHS hospital Trusts implement the standards. 125 hospitals in England have already signed up for the standards.
The NHS in England is also introducing the GSRN for unique patient ID as part of its Connecting for Health Initiative.
GSRN Example - Newborn Screening Programme
Background: The newborn screening programme routinely offers blood spot teats, “heel prick test”, for all babies within the first few days of birth. The filter paper is sent to a laboratory for testing within to identify illnesses or conditions that would benefit from early treatment. One problem has been tracing babies through the system to ensure that they have been tested. Until recently this has only been possible by using names and other personal identifiers because the NHS number was typically not available at the age when screening was carried out (6-14 days). Since the introduction of the NHS Numbers For Babies in October 2002 it is possible to for tracing to be based on the NHS number because babies are now given their unique identifier after birth.
The Objective: is to make sure that the screening laboratory receives the blood spot filter paper test card with the NHS Number represented as a barcode as well as in a human readable format, it also contains basic birth and demographic details on a label.
Specifically, the aim is to enable all maternity units to provide the mother with the NHS number before discharge from the maternity unit.
The labels provide enormous benefits , midwives do not have to handwrite all the basic birth and demographic details, thus saving time and reducing errors on both the writing and reading stages.
The use of bar-coded labels enables the NHS numbers to be used as a unique identifier within the screening process and also to track babies throughout the system. Being able to correctly identify and track the progress of babies is fundamental to reducing the risk of babies going untested or not being tested in a timely fashion. The NHS number is contained within the GS1 Standard GSRN., The GS1 data standards and bar code symbol were adopted by the NHS to optimize the solution.
For more details see Appendix 4
GS1 Ireland’s Proposal
Unique Healthcare Identifier
Having regard to the requirements described in Appendix 2 of the Health Information discussion paper, GS1 Ireland proposes that
1. The GSRN (Global Service Relationship Number) be adopted as the unique patient identifier for the entire healthcare service
2. All healthcare professionals should be identified by a GLN (Global Location Number).
The reasons for using the GSRN as the unique patient identifier are: -
Global Uniqueness
Numbers assigned using the GS1 Standards and structures are globally unique by virtue of how the GS1 Standards are deployed in over 150 countries world wide. There is no possibility of the same number being allocated to a different patient.
Non significant
The number itself is non-significant and contains no data about the patient. It is merely used as a unique index or key access data on a database for example an Electronic Health Record. Access to the data is restricted by secure healthcare practices for IT solutions.
Sharing Information
As the number is globally unique there is the possibility of sharing patient data between different applications at different sites without disclosing the patient’s identification. It can facilitate the sharing of data between Public and Private Healthcare Institutions without using the patient’s PPS number.
It would provide an appropriate solution for patients who don’t have PPS numbers, for example tourists.
Given the fact that every European citizen has the right to treatment in the country of their choice the GSRN would ensure uniqueness of identification not only locally but on a Community wide basis.
As with the NHS, the GS1 GSRN could be adopted as an EU wide identifier, given that each Member State has a GS1 office capable of providing support to their respective healthcare authorities.
Registry for Unique Patient and Provider Identification
GS1 would be happy to assist with the software solution for a registry of patient and provider identification which would be managed and controlled by a Body within the Healthcare System. The registry could be used to assign numbers to new born babies as well as all other citizens for the accurate identification of their treatment throughout the entire healthcare service.
Unique Identification of Healthcare Professionals
The recent report of the Commission on Patient Safety and Quality Assurance calls for a Group to collaborate on the scope, design and implementation of a credentialing system on a universal basis R6.20,
The assignment of a unique identifier (GLN) to each provider of healthcare services (doctor, nurse, pharmacist etc.) would provide certainty of identification for such a system.
Furthermore, R6.21 suggests that the Group should pro-actively participate in an EU-wide credentialing system, GS1 in Europe can provide the necessary globally unique numbering system for this purpose.
As previously stated GS1 Ireland proposes the adoption of the GLN for the purposes of accurate tracking and tracing of all healthcare professionals, the availability of a unique provider identification would assist in the management of an accurate credentialing system.
Appendix 1
GS1 Global Adoption
Healthcare
Regulations and policies by national and regional authorities
Region / Scope / Authority / Citation / Date / Summary of Requirement /USA / Pharmaceuticals / US Food and Drug Administration / 21CFR Parts 201, 606, 610 / 2/4/2004 / Requires a linear bar code on most prescription drugs and certain over-the-counter drugs commonly used in hospitals and dispensed under order. NDC must be coded in GS1 or HIBCC.
Although not stated as a requirement, FDA has indicated a recommendation for RFID.
Brazil / Pharmaceuticals / ANVISA (National Health Surveillance Agency) / Resolution 802 / 10/8/1998 / Ministry of Healthrequires all medicines to have GS1-13 on their packages, and the GTIN must be informed in the application form for registering the medicine.
Brazil / Pharmaceuticals / ANVISA (National Health Surveillance Agency) / Resolution 320 / 11/22/2002 / Lot number and expiry date of each pharmaceutical product delivered to the retailers must be informed in the invoice
Chile / Pharmaceuticals / Public System and the Healthcare Minister / Working on a pilot program to build a proof of concept and benefits of the use of bar codes.
México / Pharmaceuticals / Instituto Mexico del Seguro Social (IMSS)
CANIFARMA / March, 1994 / Requires a linear bar code (for all pharmaceuticals and medical devices) that dispatch and/or sale products to the IMSS and the CANMIFARMA.
México / Medical Devices / Instituto Mexico del Seguro Social (IMSS)
CANIFARMA / March, 1994 / Requires a linear bar code (for all pharmaceuticals and medical devices) that dispatch and/or sale products to the IMSS and the CANMIFARMA.
Belgium / Pharmaceuticals / Royal Decree / Bar code, sequential code per sales unit, only reimbursed pharmac. products
Croatia / Pharmaceuticals / Ministry of Health / Regulation for GS1 coding on pharmaceutical products, however there is no reg / All pharmaceutical companies in Croatia barcode their products using GS1-13.
Former Republic of Macedonia / Pharmaceuticals / Pursuant to the Article 48 of the Law on medicines, auxiliary medicinal remedies and medical accessories (" Official Gazette of the Republic of Macedonia", No.21 May 8th, 1998), all the pharmaceutical and medical products in the Republic of Macedonia must have the bar code GS1 13. All the pharmaceutical producers are members of GS1 Macedonia and they obligatory use the EAN-13 bar code.
Former Republic of Macedonia / Medical Devices / (See Pharmaceuticals)