Five Laboratory Trends To Watch

Looking for ways to make the laboratory more efficient and effective? Take note of five evolving trends that are shaping how labs identify, organize, and share information — trends that can help lab staff focus more on science and patient care, and less on paperwork.

1.) 2D barcode use in specimen ID

Barcodes are ideal for fitting large amounts of data on a specimen label. Most large labs now use barcode technology consistently, and more small to medium-size labs are using barcode systems as they become more affordable.

Linear (one-dimensional) barcodes are based on bars and spaces, such as on UPC codes. Newer, two-dimensional (2D) barcodes are based on “dot” locations within a matrix, such as data matrix and Aztec codes. For labs, barcodes are favored over traditional identification methods (like handwriting) because they improve speed, management, reporting, cost-effectiveness, and readability.

Perhaps the biggest advantages barcodes offer in the lab is data accuracy. Industry statistics show that handwritten labels have an error rate of one in 200; the linear barcode error rate is one in 2 million; 2D barcodes have the lowest error rate of one in 10 million.

2D barcodes are being used more widely in labs, taking the place of linear barcodes. 2D barcodes are smaller and can hold more data and multiple patient identifiers. They contain rigorous error checking, and have a higher tolerance for printer damage than linear bar codes.

Today, more manufacturers are permanently etching pre-assigned 2D barcodes onto a tube or vial, giving labs a jump-start on specimen ID. These 2D barcodes, however, should not be the lab’s only identification. It is advisable to add customized identifiers — typically, on the side of the tube — to avoid duplicate numbers that may occur when using pre-coded vials from multiple manufacturers. This also lets users add information to tubes or vials that is specific to a lab’s operations.

2.) Standards for ID and labeling

As labs increase barcode use, industry organizations are recognizing a need to set standards around nomenclature and other areas of biospecimen tracking. These standards enable the industry to generate data that can then be leveraged by all types of labs. Here are several examples.

Logical observation identifiers names and codes (LOINC) offers a definitive standard for identifying clinical information in electronic reports. Its main goal is to facilitate the exchange and pooling of clinical results for clinical care, outcomes management, and research by providing a set of universal codes and names to identify laboratory and other clinical observations.

Prominent organizations are adopting LOINC standards, including the Harvard Medical School-Partners Healthcare Center for Genetics and Genomics, and the Chicago Department of Public Health. Healthcare organizations are finding value in databases like LOINC and partnering with companies (e.g., 3M Data Services) to help them migrate their existing clinical data to LOINC-compatible data.¹ That way, labs can prepare and test samples to ensure universal understanding as they share information.

The International Society for Biological and Environmental Repositories (ISBER) is another resource which bills itself the leading international forum for promoting consistent, high-quality standards, ethical principles, and innovation in biospecimen banking by uniting the global biobanking community. ISBER offers best practices for what should and should not appear on laboratory labels, as well as details for human and non-human lab specimens. The organization recommends using labels whose adherence and ink are tested for specific lab conditions, and labels that create a link between the sample ID and voucher.²

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) establishes testing guidelines (based on test complexity) to ensure quality laboratory testing. CLIA also sets provisions on which tests are waived.³ To be CLIA certified for non-waived tests, laboratories must meet code 42 CFR Part 493, which requires (in section 493.1242) that labs, where applicable, must label specimens with a unique patient identifier or name, and specimen source when appropriate.

3.) Bioinformatics sharing

As more labs adopt organizational standards, more opportunities for bioinformatics sharing will arise. With the development of new software tools, along with consistent barcode standards and data terminology, cross sharing data is becoming more possible while actually increasing lab efficiency along the way. The industry, however, needs protocols for data being collected, whether on tissue cassettes, slides, vials, or any other specimen containers.

One of today’s most advanced efforts is the National Cancer Institute’s (NCI) Biomedical Informatics Grid (caBIG) initiative, an information network supervised by the NCI’s Center for Bioinformatics and Information Technology.⁴ The goal of caBIG is to enable cancer researchers, clinicians, and institutions to leverage a shared repository of information on specimens.

Nearly 60 NCI-designated cancer centers and 16 community cancer centers are connected to caBIG tools and infrastructure, with a growing number of users. Researchers and clinicians at these institutions recognize caBIG’s capabilities and its potential to speed basic and clinical research by providing data connectivity. caBIG is also important for labs that apply for grants of more than $500,000 from National Institutes of Health, which require them to have a plan for data sharing.

To meet requirements of the caBIG initiative, each specimen within the network must be uniquely identified for biospecimen tracking. Collaboration is also critical, as “the large volumes of research data created by high-throughput genomics and proteomics can best be collected by teams” and “across … broad disciplines.” Labs that share data can “raise the visibility of” their “studies and data collections,” opening new channels for “data dissemination and validation.”⁴

Meanwhile, the public-health laboratory-interoperability project (PHLIP) is establishing reliable data exchange between state public-health labs and the Centers for Disease Control and Prevention by fostering collaboration in information technology and lab science. The collaboration is intended to extend beyond the founding partners, and participants are required to map their local codes to LOINC. Of particular interest is PHLIP’s development of an electronic data-sharing exchange for nationally notifiable diseases.⁵ Initiatives like these are also extending beyond national boundaries so lab data can be studied and understood worldwide.

4. ) LEAN specimen work cell and 5S

As new standards and technology are introduced into a lab, using LEAN initiatives can help improve safety; eliminate wasted motion, space, and supplies; reduce errors; and automate the specimen-handling process. Here are two techniques to help to help LEAN your lab.

5S workplace organization: The 5S concept is designed to reduce waste and optimize productivity through better workplace organization. It centers on maintaining order and using visual cues to reduce wasted time spent searching, waiting, and asking. Here are some ways to apply 5S to a lab:

• Sort through all items in a specific area. Mark all unnecessary items with a red tag or sticker. Move those into a temporary holding area where management can determine how to dispose of them.
• Set in order: Determine the best location for remaining items. Set inventory limits and triggers for reordering.
• Shine: Clean the entire laboratory to eliminate contamination sources. Use the opportunity to inspect lab equipment for abnormalities; stop impending failures before they occur.
• Standardize: Create guidelines and procedures for maintaining the first three ‘S’es. Use visual controls such as checklists and schedules to provide regular instructions on how to maintain order.
• Sustain: Regularly communicate and train employees to maintain the lab’s adherence to 5S standards.

Work-cell specimen processing: The work-cell concept involves arranging the lab environment into work cells by creating a logical layout of all testing and processing equipment, technicians, and materials through which a specimen flows. Work cells minimize movement, reduce batch sizes, decrease set-up time, improve lab safety, and standardize work processes to reduce errors. The goal is to move toward equipping and arranging the lab, and cross training staff, so that any given specimen can be processed from start to finish while eliminating potential backlogs like waiting for batch labeling or the availability of specialized, limited-function staff.

5.) Sustainability of specimen

Sustainability is a prominent topic in the lab — not only for infrastructure but also for the life of samples and information. More labs are seeking green building and leadership in energy and environmental design, or LEED, credits, as well as looking for new ways to lower their energy consumption. Labs are also gaining sustainability by right sizing: instead of “over designing” a facility, buy equipment that best helps the lab establish a LEAN workflow.

How can the life of lab samples be better sustained? First, ensure the sample ID lasts as long as the sample needs to last. If the need is to retrieve samples from years ago, lab staff should be confident that the information is still clear and relevant. Second, make sure samples are marked with permanent identification. When using labels, here are some important considerations:

• Labels should be tested to withstand all processes, such as liquid nitrogen, autoclaves, freezer, and hot water baths.
• Labels should be tested to last the life of the sample. Some labels can last up to 20 years in storage.
• Use the most permanent print technology — thermal transfer printing provides the most reliable identifications for labs. Print should be able to endure your processes without smearing or fading.

Many labs also want to sustain the life of information beyond their own use. By using barcodes, durable labels, and standardized practices, data can be easily understood by others in the research community. It also enables the creation of a scalable ID and tracking process that can easily accommodate expansion if a lab operation grows quickly.

Labs are waving goodbye to the era of keeping research results in notebooks and on flash drives. Consider how these trends can help make the lab more efficient and effective, and how collaboration can help lab technicians perform their work better while improving patient outcomes — now and into the future.

Annie Ropella works in laboratory material product marketing for Brady North America. To learn more about these trends and Brady’s identification and tracking solutions, visit Brady ID.

References

1. LOINC Adopters. Organizations, institutions, and other LOINC adopters. http://loinc.org/adopters. Accessed January 25, 2011.
2. McGee J. What is the Best Way to Use Barcodes to Label or Track Samples in Biobanks? Isber News. 2010;10(3):5-6. http://www.isber.org/newsletters/October2010.pdf. Accessed January 25, 2011.
3. Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments. How to Obtain a CLIA Certificate of Waiver. https://www.cms.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf. Accessed January 25, 2011.
4. National Cancer Institute. About caBIG. https://cabig.nci.nih.gov/overview. Accessed January 25, 2011.
5. Public Health Laboratories. Community-Driven Standards-Based Electronic Laboratory Data-Sharing Networks. Public Health Reports. 2010;125 (2010 Suppl 2): 47-56. http://www.publichealthreports.org/archives/issueopen.cfm?articleID=2423. Accessed January 25, 2011.