March / April 2009
To realize barcoding’s promise, all stakeholders in the point of care must work together to ensure sufficient interoperability and coexistence among products and systems.
Barcode technology has long been hailed as an effective tool in the struggle to improve patient safety. The risks and advantages offered by barcodes have been well known for a decade or more (Leape et al., 1995; Brennan et al., 1991; Low & Belcher, 2002). The concept of barcodes goes back to 1948, and the first scanner was installed in a Cincinnati Kroger grocery store in 1972 (Reynolds, n.d.).
In spite of the fact that the needs are well understood and the technology mature, barcode technology adoption in hospitals has yet to meet the expectation of many in the industry. According to an American Society of Health-System Pharmacists (ASHP) national survey on the adoption and use of pharmacy informatics, by the end of 2007 only 24.1% of hospitals were using barcode medication administration (BCMA) systems (Pedersen & Gumpper, 2008). Future adoption forecasted by the study was mixed. While 31% of respondents expect to adopt BCMA in 1 to 3 years, 23.3% have no plans for such a purchase. The HIMSS Leadership Survey for 2008 also reports adoption intentions. The HIMSS survey reports on two barcode point-of-care (BPOC) applications: closed loop medication management and barcode technology adoption. Among the most important applications over the next 2 years, closed loop medication management ranked fifth out of eight, with 30% reporting adoption plans in 2008. In 2007, this application did not make the “most important” list. Barcode adoption was surveyed as a component of technology adoption, again over the next 2 years. Barcode adoption came in last out of nine technologies. For 2008, 35% expected to adopt over the next 2 years. Last year’s survey reported that 74% plan to buy. This data tells us first that intentions always exceed actual adoption. The data are also indicative of continued interest in applying the benefits of barcode technology to medication administration and other applications in healthcare.
Barriers to Adoption
Given the documented patient safety need and potential benefits of barcodes, why is adoption so slow? Four barriers to BPOC adoption have held back barcode adoption. Broad adoption is dependent on:
- Overcoming a common causality dilemma.
- Mastering the highly complex workflows that are the target for some high-profile BPOC applications.
- Recognizing and accommodating the suitability of barcoding for specific applications or tasks.
- Overcoming the absence of interoperability and coexistence of barcode technology across applications.
A structural barrier to BPOC adoption is the “chicken or egg” problem (Wikipedia). Vendors have little incentive to shoulder the cost of adopting barcodes if customers have no scanners with which to read them. Likewise, providers have no reason to buy scanners when there are no barcodes to be read. This causality dilemma is most problematic with applications where barcodes span multiple entities from manufacturers, to distribution and finally end user/buyers. In such situations it is difficult for all the parties to agree on details such as what data is to be encoded and how. Justifying adoption costs is difficult for any individual link in the chain, because it is not known when or if others will adopt.
The FDA has lent its weight to overcoming the barcode causality dilemma with two mandates (FDA, 2006). The FDA issued a rule mandating barcodes on drugs in 2004 with an update in 2006. Also in 2006, the FDA published a rule specifying barcode requirements for blood products. The FDA is presently evaluating the definition of a UDI (unique device identification) for medical devices (FDA, 2009). Most likely barcoding, as well as other technologies, will be adopted to support the UDI application.
External to the healthcare industry, the supply chain industry has adopted numerous UDI product labeling standards, many based on the GS1 standards (www.gs1.org). Based on the data reported in the ASHP survey above, these requirements have yet to create a tipping point that will spur more rapid adoption of BPOC. Such a poor response from the market suggests that factors beyond causality are hindering the adoption of barcode technology.
Barcodes have been widely adopted in hospitals for certain applications for many years. Many of these applications, like barcode medication administration systems (BCMA) for pills, shots, and drops, entail complex and variable workflows. Awareness of nursing workflow complexity is low among many. “A sure way to anger a nurse is to suggest that grocery stores, with their barcodes and scanners, have more automation that hospitals,” says Ann Farrell, BSN, RN, principal, Farrell Associates. “If grocery stores were really like hospitals,” she reports, “they would buy Doritos by the bag, but have to repackage and label individual chips, and then track every chip — who bought it, who ate it, and whether they ate it in an appropriate quantity and with only complementary foods and according to dynamically calculated nutritional needs.”
The complexity of nursing workflows is frequently underestimated by product developers and those who buy and implement workflow automation systems. Farrell noted recent studies to back up this contention. The Joint Commission issued Sentinel Event Alert 42 (2008), titled “Safely Implementing Health Information and Converging Technologies.” The alert noted that, “of the 176,409 medication error records for 2006, approximately 25 percent involved some aspect of computer technology as at least one cause of the error. Most of the harmful technology-related errors involved mislabeled barcodes on medications (5 percent), information management systems (2 percent), and unclear or confusing computer screen displays (1.5 percent).”
Another study mentioned by Farrell is, Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions, published by the National Research Council in January 2009 (Stead & Lin). The report, based partially on site visits to eight U.S. medical centers that are leaders in the field of health care IT, notes that
medical workflows are often complex and non-transparent and are characterized by many interruptions, inadequately defined roles and responsibilities, poorly kept and managed schedules, and little documentation of steps, expectations, and outcomes. Many of the systems criticized by the committee that produced the report made extensive use of barcode technology.
The committee moved beyond product design to criticize how these systems are purchased and implemented. The report noted that while many healthcare institutions spend considerable money on IT, implementation is done in a way that makes even small changes hard to introduce.
Koppel et al. (2008) published a landmark paper on BCMA, documenting workarounds, their frequency, and correlating them to causes and threats to patient safety. A total of 15 workarounds were identified along with 31 different causes. According to Farrell, the paper offers product developers and prospective buyers the best description yet of pitfalls and problems to avoid. Vendors have underestimated the challenges of capturing and automating workflow, as have most hospitals. According to Igor Nesterenko, Alaris product manager at Cardinal Health, “Most early adopter hospitals try to figure out workflow after purchasing a system, as they go through implementation.” Nesterenko reports that experienced buyers figure workflow out in advance.
Many conclusions can be drawn from these reports, but the inescapable fact is that some applications utilizing BPOC have not met their promise. Over time, better product designs and implementation methodologies will evolve.
Like any other tool, barcode technology has both strengths and weaknesses. In spite of this, it seems that the technology has been adopted in an almost indiscriminate manner. A review of the market suggests that BPOC is more suited for some applications than others.
Barcode technology has been in use in hospitals for many years. Common barcode applications are focused solutions to problems on the departmental level, rather than at an enterprise scale. These established applications targeted simple workflows with limited variability. The clinical lab and pathology departments frequently use barcodes to track specimens and convey configuration data to analyzers in a machine-readable format. Barcodes are frequently included in the HIS order-entry system’s printed orders. Many of these barcodes are then used within various departments for workflows of modest complexity.
More recently, barcodes have been adopted for point-of-care diagnostic testing (POCT). According to Dan Molloy, systems solution marketing manager for Abbott Point of Care, “In 1998 when Abbott launched the Precision Exceed Pro hospital glucometer, about 10% of hospitals were using barcodes.” Regulations require documenting the person completing the point-of-care test and the patient. “Hospitals that did not implement barcoding suffered significantly greater misidentification error rates compared with hospitals using barcodes.”
The POCT workflow is straightforward and does not vary. For example, the Abbott system pushes patient demographics into the Precision POCT device, where it is confirmed by reading a patient’s barcode. “Our system has just three things that need to be captured: patient, operator, and test cartridge,” says Molloy. He reports that hospitals using barcodes and HL7 admission, discharge, and transfer (ADT) feeds have achieved positive identification rates of 99.9%. Clearly BPOC can be a potent workflow automation tool.
Closed loop medication administration systems for smart pumps is another area where barcode technology has been the default automatic identification technology. Development on these systems started almost 10 years ago. Like BCMA for pills, shots, and drops, workflows associated with administering infused therapies are very complex. Unlike BCMA, smart pump medication administration requires considerable systems integration and implementation of computerized provider order entry (CPOE) and other advanced electronic medical record subsystems. Consequently, the adoption of smart pump medication administration systems is waiting for the market to “catch up” with broader healthcare IT applications before it can move forward.
The current state of smart pump market is that most hospitals have adopted infusion pumps with drug error recovery systems (DERS). Many of these pumps are network enabled, and include barcode technology for nurse and patient identification for DERS reporting, known generally as continuous quality improvement (CQI) reporting. The value of CQI data is greatly enhanced when it is associated with a particular clinician and patient. In spite of the increased value, fewer than a handful of hospitals in the U.S. are known to capture patient- and user-identified CQI data (E. Sparnon, personal communication, June 2008).
Several issues have hampered the use of barcodes with smart pumps. “It’s hard to take a workflow, integrate new technology, and cut steps in workflow.” said Nesterenko. Current smart pump systems offer no direct benefit to the nurse for capturing caregiver and patient ID for more meaningful CQI data.
Unlike the use of barcode technology for point-of-care solutions in the clinical lab and pathology, perhaps BPOC is not the appropriate technology for other applications.
Interoperability and Coexistence
When any technology such as barcoding is utilized by multiple vendors in the same market, problems arise. This is especially true in markets where the common product strategy is to create proprietary end-to-end solutions. The point-of-care in hospitals is one such market, where a plethora of healthcare IT and medical device manufacturers are creating solutions targeted at the same end user: nurses.
Each vendor creates its solution with little or no thought to other vendors’ products that may be in use at the point-of-care. To reduce product development costs and shorten time to market, vendors frequently make use of commonly available technologies. The consequence of this approach forces hospitals to buy duplicate equipment and to struggle with getting their systems to support the most basic compatibilities such as a common barcode symbology. For example, consider a hospital that has installed Sensitron for vital signs capture, uses B. Braun smart pumps with built-in barcode readers, has IntelliDOT’s BCMA, and is adopting point-of-care testing devices from two different vendors. This customer will likely end up with 5 separate barcode scanners, one for each vendor’s system. While some of these scanners may be identical, others must be dedicated to their system.
It is little wonder that barcode adoption has lagged when hospitals must struggle with:
- the proliferation of barcode readers, and the resulting cost and confusion,
- usability problems due to variation among vendor’s workflows associated with barcode scanner use, and
- additional systems integration and management requirements to enable each system to read the same barcodes.
Nesterenko also noted that, “Hospitals want one handheld barcode reader that scans for all the various systems and applications.” Buyers are stymied however, because such a solution does not exist. As a consequence, barcode adoption for smart pumps frequently becomes an “enterprise decision” that spans multiple applications at the point of care. Hospitals hesitate to implement BPOC for one vendor without having considered the implications of the other BPOC applications destined to be implemented.
This situation is the result of the broad adoption of BPOC in the absence of coordination among vendors deploying systems utilizing barcodes at the point of care. This lack of coordination contrasts with other industries where consortiums or alliances of some kind normalize the adoption and implementation of technology across vendors. Examples in the information technology market include the Wi-Fi Alliance, Bluetooth Implementers Forum, and the ZigBee Alliance. Similar organizations exist in most other industries. These organizations start with industry standards, develop implementation guidelines, and provide test and certification to ensure cross-vendor interoperability and coexistence.
The adoption of BPOC will be hobbled until there is some means to minimize barcode reader duplication and normalize barcode workflows across all products at the point of care. To date, the only alliance of this type in healthcare is the Continua Health Alliance, founded mostly by companies from outside of healthcare.
Existing vehicles for this type of work include the Integrating the Healthcare Enterprise (IHE), and various entities sponsored through the Office of the National Coordinator (ONC) for health information technology. The IHE may offer hope as a suitable vehicle for resolving barcoding issues but has made little progress to date. Further, the IHE is challenged because the current structure of technical frameworks necessitates solving barcode problems across multiple workgroups. The ONC’s mission is the creation of a national health information network; the task of facilitating barcode adoption will take years to rise to the top of the ONC’s agenda.
Perhaps none of these organizations are well suited to the task at hand, given the long standing need and little progress in rationalizing barcode use in healthcare. While at an industry conference in 2008, one prominent industry leader noted that, “It’s a poor reflection on the healthcare industry that the federal government has to actively enter a market to drive standards and interoperability. You don’t see that in other industries like IT, telecommunications, or logistics.”
Summary and Conclusions
Like any other technology, barcode technology is not a panacea. There are a variety of other methods to establish identity, from the long established pick list on a medical device or computing device to passive RFID tags. Buyers must assess their workflow requirements before buying.
Rather than carefully assess workflow requirements in detail, many healthcare IT and medical device manufacturers accept BPOC as the “best” technology for capturing caregiver and patient identification. A careful assessment of workflow at the point of care is not a trivial task, yet the proliferation of adoption problems like the workarounds reported by Koppel et al. suggests that much more needs to be done.
The industry as a whole, both healthcare providers and vendors, should adopt formal methods for capturing workflow. Buyers need workflow data in order to evaluate potential solutions. Vendors need workflow data that directly translates into specifications, before systems will reliably automate workflows in customer sites.
Finally, all stakeholders in the point of care must work together to ensure sufficient interoperability and coexistence among various products and systems. Whether this is realized by existing organizations like the IHE, or is the result of new alliances or consortiums, the promise of BPOC will remain unrealized until interoperability and coexistence are achieved.
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