If you were explaining CLSI to someone who is not familiar with the organization, how would you characterize its primary areas of expertise? CLSI publishes documentary standards and guidelines for use by lab professionals. CLSI is unique in the field of lab medicine in that we’re the only fully accredited standards development organization that has the convening power to bring affected stakeholders from government, healthcare professions, and industry together in a neutral forum to develop common solutions to common issues. Our standards are used globally to facilitate best practices for medical labs of all types, and for accreditors, regulators, public health officials, professional societies, trade organizations, and pharmaceutical and in-vitro diagnostic companies, among others. Our current library consists of 160 consensus standards in most disciplines of laboratory medicine. But our standards are only relevant and impactful if they are implemented. To encourage stakeholders to use our documents, CLSI has focused on making our standards and companion products easier to understand and searchable. We’ve also included more practical templates and forms.
How would you characterize the general importance of standardization in the lab? Perhaps more than any other healthcare discipline, the medical laboratory lends itself to a high degree of global standardization. The foundations of good lab quality practices based on a common quality management system are the same anywhere in the world. The globalization of lab services is occurring as a result of rapid advances in common standards of best practices, communications and information technology, and instrumentation platforms, as well as the ease and frequency of modern travel.
The medical lab plays an essential role in the diagnosis, monitoring, and treatment of all of the major public health crises related to communicable diseases such as Ebola, Zika, and SARS, and noncommunicable diseases such as diabetes, hypertension, and cancer. Global standardization ensures that no matter where a patient is tested, he or she can expect the same quality results. CLSI is proud to play an essential role in the global standardization of best practices.
How do clinical laboratory staff make use of CLSI’s standards and guidelines documents? What are some recent guidelines laboratorians should know about? All laboratorians have a core responsibility to ensure that the highest quality lab results are produced. I can think of no better way to do this than ensuring their lab’s use of CLSI’s standards. The authors of our standards come from diverse sectors of healthcare, which ensures a fair and balanced outcome. For example, a given standard may have authors from both an accreditation agency and a laboratory that’s being accredited. Meeting in a neutral forum to create consensus standards for the benefit of all contributes to the global knowledge of best lab practices and is a satisfying endeavor. CLSI authors know they have a hand in making a truly positive difference in healthcare.
For example, we recently published QMS25—Handbook for Developing a Laboratory Quality Manual. This handbook is particularly helpful, as the quality manual is an essential requirement for efficient operations of any laboratory. CLSI has an entire library of Quality Management Systems documents and products. Using these is an excellent way for any laboratory to improve efficiency and the quality of patient test results.
Several months ago, we published the 7th edition of GP41, CLSI’s venipuncture specimen collection standard, which has more than 200 updates from the previous version. Another document was recently released about a timely technological advance in the microbiology lab, MALDI-TOF for microbial identification, M58. In January we published three seminal methods documents in microbiology, having to do with antimicrobial susceptibility testing—M2, M7, and M100-S28.
Why is this topic of antimicrobial resistance of particular importance now? Antimicrobial resistance is a top global public health problem; diseases know no geographic boundaries. It’s more important than ever before for laboratories to keep up with the latest developments in the treatment of multidrug-resistant organisms and to become involved in antibiotic stewardship.
In that context, one of the documents we published in January, Performance Standards for Antimicrobial Susceptibility Testing (M100-S28), is of great importance. Clinicians depend heavily on information from the microbiology laboratory for treating their patients, and M100-S28 helps the laboratory provide clinicians with the most up-to-date recommendations for the best antibiotic treatment options for their patients. It provides recommendations for optimal testing conditions and shows laboratories how to report results for the newest antimicrobial agents.
How are evolving regulatory and legal contexts changing the work of CLSI and its value to labs? It’s almost a cliché to say that in the future we will be doing more work with fewer financial and human resources. CLSI doesn’t directly engage in regulatory or financial aspects of laboratory medicine; rather, our standards all focus on doing the right things the first time, which improves quality by saving time and money.
What are the benefits of membership in CLSI? CLSI has approximately 1,700 members. The majority are organizational members, but we also have a membership option for individuals. Certainly, one of the major benefits of CLSI membership is access to our library of 160 laboratory standards. Other benefits include the ability to propose the development of new standards, contribute expertise to the standards development process, comment and vote on draft standards in development, and stay current with new and revised publications. CLSI membership also affords professional growth opportunities to network with other laboratory professionals and leading experts in your field.
What kind of a global impact is CLSI having? CLSI’s mission is to create standards and promote their implementation, and the second part has been our focus internationally during the past 10 years. Our Global Health Partnerships program is currently active in 12 countries, and CLSI has directly supported 26 laboratories in resource-constrained countries to achieve internationally recognized accreditation based on our standards. Additionally, we are assisting almost 40 other labs in various stages of accreditation preparedness. Finally, our important leadership activities within ISO and the World Health Organization have been instrumental in helping CLSI achieve our mission.
The aging of the lab workforce—and in some cases a reduction in the number of skilled, bench-specific laboratorians—are topics of concern in the industry. How can CLSI be part of the answer to the challenges these trends pose? Since there are fewer accredited programs in clinical laboratory science and allied health college majors, the focus should be on training students in quality assurance and best practices. Labs will still be expected to produce the same high-quality test results with a reduced staff that has less experience than those retiring from the field. One of the best ways to ensure that new laboratorians will be successful is to make sure that quality management systems is an integral part of the laboratory scientists’ curriculum. CLSI offers a student membership at a significantly reduced rate. With this membership, students can volunteer to participate on document development committees and learn firsthand about best practices and quality