To trace or not to trace: that is not the question.
For obvious reasons, traceability in the healthcare industry is no longer an option; It is a must--governed by regulation. For instance, the Blood Safety and Quality regulation No.50-made under Section 2(2) of the European Communities Act 1972 and transposed into two EU directives and UK law-requires that hospital transfusion laboratories maintain the data needed to ensure full traceability of blood and blood components for a period of no less than 30 years. However, while regulators are quick to demand that medical supplies, hospital beds and, no less importantly, patients be traced throughout the healthcare system, they only dictate the kind of information that needs to be collected and traced, not necessarily the particular traceability systems that should be used to achieve this goal.
The question is, therefore, no longer whether to trace or not, but which traceability solution one should apply. A Chief Information Officer's task of selecting a traceability solution that best answers his or her organization's particular needs is not an easy one. A large number of options are available and, to complicate matters further, their effectiveness in addressing different traceability challenges varies greatly. At the heart of each traceability solution is a data capture technology. It is usually the case that no single technology can address all requirements perfectly. This article will outline the various healthcare applications that call for the deployment of traceability solutions. It will also review the key data capture technology selection criteria, while introducing a unique and innovative approach to implementing traceability-solutions that offers distinct advantages compared with traditional methods.
Health industry traceability applications
Asset Tracking: All healthcare facilities have one thing in common--valuable assets, such as hospital beds, medical equipment, wheelchairs, scanning devices and many others. Losing track of any of these will cost a medical facility anywhere from hundreds to millions of pounds. According to the American JCAHO (Joint Commission on Accreditation of Healthcare Organizations), the primary reason for emergency department diversion is lack of critical care, medical and surgical beds. A traceability solution could drastically reduce the chances of this happening, while improving healthcare service efficiency and driving down costs. RFID (Radio Frequency Identification), for instance, has successfully been used in many industries to track high-value assets, and is, therefore, also on the shortlist of healthcare facilities looking to implement traceability solutions. However, this technology and its performance are sensitive to such elements as metals, water and electromagnetic frequency, all of which are in abundance in typical hospital environments. The technology may also raise concern over interference with medical facilities' existing systems.
Legislation and industry changes are placing increasing pressure on the implementation of pharmaceutical traceability. For example, the FDA has recommended item-level tagging of drugs that have a high likelihood of being counterfeited, and is calling for all drugs at pallet, case and item level to be tagged as well. The World Health Organization states that 5-8% of all pharmaceuticals are counterfeit and that far greater counterfeiting rates, reaching as high as 40%, are prevalent in a number of countries. These figures translate into more than $46 billion of losses per year for the pharmaceutical industry, not to mention the introduction of potential hazards to patients' health.
Pharmaceutical manufacturers stand to gain significant benefits from the implementation of traceability solutions throughout their supply chains. Item-level traceability will provide them not only with global visibility and control, and the ability to quickly recall life-threatening medications, but also with sizeable paybacks resulting from far faster stock counting, better supply chain management, and theft and counterfeiting deterrence.
Patient safety and error prevention
Effective traceability solutions can dramatically increase patient safety, and even operating efficiency, simply by keeping tabs on a patient's location and authenticating that they be prescribed the right medication dosages or directed to the right medical procedures. For example, the FDA has cleared technology that can be used to match patients with surgical procedures, specific medical staff members, and urine or blood samples. This technology, which maybe implemented by tagging patients with disposable wristbands (assuming privacy issues don't get in the way) and affixing printed labels or electronic chips to medications, syringes and other medical gear, can even be used to detect and document erroneous medical procedures to ensure legal and regulatory compliance, and to prevent future recurrence of potentially life-threatening errors.
How to choose the right traceability solution? THAT is the question!
It can be seen, therefore, that traceability is a vital component of the medical industry. The problem comes when deciding which of the vast array of options--which include active and passive RFID tracking solutions, barcode, Data Matrix and proprietary visual tag-based traceability solutions--to choose. Without official regulatory direction and qualified professional guidance, how does one go about making the right choice? The first step to answering this question lies in identifying the most important selection criteria, a range of which is listed below in Table I.
Line of sight: When line of sight with the items that need be tracked cannot be guaranteed, RFID is most likely the solution one should consider. However, RFID does have its limitations in the liquid, metal and sensitive equipment-rich hospital environment, and line of sight can often be achieved with alternative solutions, such as imaging-based AIDC (Automatic Identification and Data Capture) systems, through intelligent deployment and minor modification of medical facilities' operational sequences.
Price: The price of a healthcare traceability solution typically comprises two elements:
* the reader--a one-time investment per reading location;
* tags--this cost element depends on the type of tags, on the number of assets to be tracked and on whether tags need be reusable or not. One must determine in advance whether the application is to use a defined bank of assets or if new tags need to be constantly produced. RFID tag prices, for instance, are in constant decline, especially when large quantities are involved (as is the case with passive tags, which cost a number of cents to a few tens of cents each). However, these will always be more expensive than, say, barcode or Data Matrix codes printed on plain paper.
Dirty, liquid-rich and extremely low temperature environments: Dirt or liquids may affect labels affixed to the items being traced. Some of the information on printed barcode labels, for instance, can be obscured and liquid or condensation can cause reflection, effectively masking visual information. RFID will generally prove less effective under such circumstances, as it suffers from sensitivity to liquids and dirt (if liquid containers, such as beverages, liquid detergents or oils need to be tracked, RFID limitations could prove to be extreme) and its performance is severely impeded by extremely low temperatures. Data Matrix labels, by contrast, should prove to be an excellent alternative in environments of this type, owing to their superior error correction capabilities.
Metals and electrical noise: Environments that are rich in metals can adversely affect RFID performance. The technology tends to suffer from severe performance degradation in all frequencies in the presence of metals, whereas visual codes are completely impervious to metal-rich environments. Electrical noise emitted by medical devices or cellular phones can also drastically reduce reading performance in RFID applications, with some frequencies potentially overlapping the RFID frequency range.
Motion: A number of healthcare traceability applications may necessitate that multiple assets be read in motion. RFID has no practical limitation in this respect, and motion can sometimes even improve its performance. Alternatively, using visual codes, such as barcode or Data Matrix will require the utilization of optical capture devices capable of performing proper imaging of objects in motion (CCD cameras with global shutters, for example). Such devices are, typically, more expensive than non-visual code-based alternatives.
Error handling: Solutions utilizing printed Data Matrix labels offer superior error correction in comparison with other traceability implementations. The Reed-Solomon algorithm, combined with a high degree of data redundancy (at times more than 50%), makes Data Matrix a very robust and error-immune technology, compared with RFID and barcode-based solutions, which employ CRCs (Cyclic Redundancy Checks) to detect, but not correct errors.
Quantity limitations and reading rate: RFID is limited in the number of assets it can read simultaneously (typically between ten assets and several tens of assets, depending on configuration). To handle an even larger number of assets, a greater number of more complex RFID readers with multiple antennae must be used. No such limit exists for visual code-based solutions. RFID decoding rates also depend on the number of assets, whereas decoding time for multiple visual codes tends to be constant, is typically faster (about twice as fast) and can even be enhanced further through additional CPUs.
Keep it future proof
Seeing as the selection criteria presented above constitute a mere part of the equation, choosing the right traceability solution can prove to be a genuine nightmare for the CIO, especially when chasing moving targets, such as the people and assets that need be traced in healthcare environments. When reviewing potential solution candidates with the above criteria in mind, it is also important to look forward. Traceabilitysolutions and, specifically, data capture technologies are constantly improving, with new ones being introduced at an ever increasing rate. The overriding consideration should, therefore, be to ensure that the system chosen is largely capture technology agnostic, so that it can best serve increasingly complex healthcare traceability needs.
The solution should be of sufficiently open design, allowing data capture technologies to be combined and, in extreme situations, even switched and replaced in their entirety. The ideal solution will enable healthcare CIOs to remain virtually obsolescence-proof, and to ensure maximum protection of earlier technology investments and minimal operational disruption, should new technologies need be integrated. Play it safe. Implement an open traceability solution with the best possible technology available today to address the particular problem at hand, while leaving your future options wide open.
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Table I: A comparison of automatic identification and data capture technologies. Handheld Passive Active Optical, Scanners RFID RFID Imaging-Based Data Capture Simultaneous multiple * * * asset capture No line-of-sight * * required Negligible tag cost * * Tag capture from afar * * Immune to RF/EM * * interference Unaffected by presence * * * of metals/liquids
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|Date:||Jan 1, 2008|
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