Navigating ISO 15189 for US Laboratories

By Jennifer Dawson, MHA, DLM(ASCP)SLS, FACHE, CPHQ, LSSBB QIHC, QLC

Although the term likely is familiar, many United States laboratorians have little experience with international quality management standard ISO 15189: Medical Laboratories—Requirements for Quality and Competence, better known simply as ISO 15189. Perhaps you have decided or been given the directive to implement ISO 15189 and you do not know where to start. Perhaps your laboratory is already on its ISO 15189 journey. The idea of learning and implementing the requirements necessary for accreditation to the standard may appear daunting. However, the seemingly uncharted waters of ISO 15189 actually can be effectively navigated. This article aims to help dispel some of the myths that discourage facilities from applying and provide tips on implementing the standard and gaining accreditation.

Background

ISO 15189 is an international standard, based on ISO/IEC 17025 and ISO 9001. The standard specifies requirements for quality management systems and competence in the medical laboratory environment. It is patient-centered, focusing on the continuum of care and patient safety, risk mitigation and operational efficiency throughout¹. Global harmonization of medical practices is one of the goals of the standard. The health and safety of patients and providers, efficient exchange of information and protection of data are also highlighted. ISO 15189 is used by laboratories, regulatory authorities and accreditation bodies to ensure quality and competence². The International Organization for Standardization has released three versions of the standard, in 2003, 2007 and the most recent version in 2012. The revised and updated version of the standard is ISO 15189:2012 (Medical laboratories – Requirements for quality and competence). The standard is often referred simply as “ISO 15189”, without reference to a version. Content of the ISO 15189 standard is divided into management requirements (Part 4) and technical requirements (Part 5)¹. ISO 15189 is a comprehensive standard that applies to all clinical laboratories, regardless of the type of lab; the standard is as relevant in a health hospital network’s laboratories as it is in reference laboratories providing clinical and/or anatomic pathology services. It is not prescriptive as to how a laboratory should conform and focuses on encouraging users to maintain an effective quality management system integrated across all parts of the business, with the ultimate goal of continual improvement³. ISO 15189 has become the international standard of excellence for medical labs. Since 2015, about 60 countries (just over 30% of all countries globally), including Australia, Latvia, New Zealand, France and Taiwan, have made ISO 15189 part of their medical laboratory requirements³. Well over a thousand laboratories in Europe are accredited to ISO 15189. In 2015, there were just over 20 laboratories accredited to ISO 15189 in the US, as of 2019 that number has more than doubled. In the United States, accreditation to ISO 15189 is currently voluntary, as no governmental or regulatory agency requires laboratories or health care providers to conform to ISO 15189. Accreditation to the ISO 15189 standard does not replace a laboratory’s federal Clinical Laboratory Improvement Amendments (CLIA) certification¹ or deemed status organization accreditation. The College of American Pathologists (CAP) and the American Association for Laboratory Accreditation (A2LA) offer accreditation to the ISO 15189 standard in the United States^{2, 4}. Implementation of and accreditation to the ISO 15189 is meant to complement existing certification, accreditation and quality management systems.

Quality is a Journey

Understanding that the implementation of ISO 15189 is an ongoing journey, not a destination, is paramount. David Wolfe, a former Lead Assessor for the CAP 15189 program, said, “You never get to the top of the mountain, because the mountain keeps moving and changing”. There is always more work to be done to improve quality. The landscape in which labs operate, technologies and best practices are ever-evolving. The goal at any given time should be to provide the highest quality laboratory services possible, but this is a moving target as our industry progresses. Lab managers from across the country have expressed to me that they are not ready for ISO 15189 and they have years of work to accomplish before they can apply. It is important to be realistic. The assessors are not going to expect perfection from your lab. There are opportunities to assess readiness for the initial onsite accreditation assessment built in to the CAP 15189 process, including a desk assessment and a gap assessment. Furthermore, at the initial assessment, assessors will be looking for the laboratory to have addressed each requirement in some way and that unexpected outcomes/situations (“curveballs”) are handled appropriately. It is expected that the different components of a quality management system (QMS) will evolve and improve over time. Embarking on the journey to accreditation sets deadlines for and creates accountability for the implementation of quality management system improvements, which may otherwise fall by the wayside. It is my recommendation that if a laboratory is considering applying for accreditation to the ISO 15189 standard and has addressed the vast majority, if not all, of the requirements of the standard at at least a minimum level, that they should move forward by submitting their application. Every lab has to start somewhere and the assessors are acutely aware of this. Because the process is voluntary, the inspections are not punitive in any way. Instead, the inspections are collaborative and conducted in the spirit of continuous quality improvement. From my experience, the gains achieved just through entering into the accreditation process for buy-in, commitment and momentum are exponential.

Value of Leadership Commitment

Implementation of ISO 15189 cannot be achieved overnight; laboratories must dedicate significant resources and appoint a quality manager to build and maintain the QMS. In general, unless the laboratory is small (fewer than 20 staff members), the quality manager should be a dedicated, full-time position. If the position is anything less, the laboratory likely will maintain the QMS at a minimum or unacceptable level, and identification of, and progress on, continuous quality improvement projects will suffer. Laboratory management should lead by example, emphasizing the importance of quality and the ISO 15189 standard for improving both patient care and laboratory operations. As such, lab management cannot isolate the quality manager in an office and expect to achieve conformance. Rather, labs should build commitment to active management into the program (as required by the standard). Such commitment is assessed during a CAP accreditation audit, as well as during subsequent surveillance. Insufficient resources to support the QMS as it is designed will become evident through assessment reports, but avoidance of non-conformities on an assessment report should not be the primary concern. It is futile to design a comprehensive QMS at a best-practice level if management does not allocate sufficient resources to maintain and evolve the program. Ideally, the requirements of the ISO 15189 standard should become integrated into the facility’s business strategies using the following required elements:

•The Quality Policy: A mission statement that continuously guides the entire organization toward its quality goals. The policy’s associated quality objectives and metrics become the measure of success.

•The Quality Manual: A document describing the quality management system, which serves as the road map for the organizational strategy to achieve the quality policy.

Lab leadership should work to maintain consistency and alignment with their vision for quality, and the organization from the top down must commit to continuous quality improvement. Employees recognize lab leadership’s values and tend to align their values accordingly. If pushing results out the door quickly is management’s chief priority, staff will conform, and quality will diminish. Therefore, leadership must serve as the role models for quality. Ultimately, fostering a culture of quality requires a high level of organizational honesty—a laboratory can improve only if its leaders are willing to admit there is room for improvement. Often this requires management to admit mistakes or to acknowledge that a chosen approach was unsuccessful. It also requires senior leaders and managers to move away from the traditional name-blame-and-shame culture. It is easy to make an example of an employee through blame and punishment. The more effective, albeit more difficult, route is to employ a systems-thinking approach to help determine root causes. A systems-thinking approach begs the questions:

•Did the system allow this to happen?

•If so, what is the root cause and how can the system be redesigned to prevent this type of event?

Implementing Just Culture principles, which emphasize accountability in a blame-free environment, can help provide a systematic framework, complete with an algorithm, to facilitate the shift toward systems thinking⁵. The goal is to achieve a culture in which personnel feel comfortable disclosing errors and near misses—including their own—in the interest of continuous improvement. Proper allocation of resources, alignment with organizational goals, and a pervasive commitment to quality from lab leadership will set the stage for quality, patient-focused lab operations.

Involvement at All Levels

Laboratories should orient and involve all staff members to ISO 15189 and the organization’s implementation plan to fully realize the benefits. A project initiation or kickoff meeting involving a general overview of the standard, as well as an introduction to the program and the development of an implementation timeline, are useful for gaining staff buy-in. Management should hold periodic meetings thereafter to ensure the organization has the most up-to-date information on the lab’s efforts, including deadline expectations and roles. Clinical labs should weave the requirements of ISO 15189 into their organizational fabric. This includes designing high-level process maps for the entire lab, as well as more detailed maps tailored to individual departments and functions. These maps allow staff members to understand how they contribute to quality and patient safety. Likewise, management should train and immerse staff in the program, providing education on the contents of the standard, the organization’s approach to conformance, and the associated benefits. Staff involvement is critical, as front-line staff provide insight as to what works, what does not, and why. Front-line staffers often are the best source of ideas for continuous quality improvement.

Moving Beyond a Checklist Mentality

The implementation of ISO 15189 takes quality initiatives one step further than basic checklist mentality compliance. For example, instead of just requiring your staff to record temperatures of a refrigerator unit, ISO 15189 requires that lab staff understand the intent behind recording the temperatures. An ISO 15189 approach is patient centered and explains that our quality efforts are not done to comply with a checklist, but instead to provide the highest level of quality possible for our patients. An ISO 15189 approach to training on temperature monitoring might include an exercise in which staff are shown three bottles of FDA cleared reagents with temperature requirements for storage. One might have been stored at roughly the right temperature, but only been checked once in a 24-hour period. Another might have not been checked at all. Of course, the best (and ISO 15189 compliant) scenario would be to continually monitor the temperatures to ensure that the reagent had been kept within its validated temperature range to ensure the integrity of the reagent for testing for our patients. It consistent with ISO 15189 to ask, “what would you want done if your family member was sick and needed this testing”? Highlighting the intent behind the ISO 15189 standard and its requirements helps staff to gain a true understanding of the purpose of the program. Explaining that the safety of patients and staff are the reason behind the “extra work” of ISO 15189 implementation helps to humanize the initiative and gain staff buy-in, loyalty and dedication to the program.

No Magic Bullet

The ISO 15189 standard is not at odds with other certification and licensure requirements or best practice guidelines. Readers likely will not be surprised by anything it contains. ISO 15189 is meant to complement the lab’s systems for complying with other requirements and to provide structure for a robust and well-rounded QMS that focuses on patient safety. A robust and effective Quality Management System is the foundation for conformance to the ISO 15189 standard. Many of the sections of ISO 15189 are the same as those in the CAP checklist or CLIA regulations, including many basic quality concepts, such as document control, internal auditing, corrective and preventive action, and management review. These sections are organized in a way that differs from that which laboratorians are accustomed and may require a more in-depth approach. Simply put, the ISO 15189 standard looks at a QMS from a macro perspective, while the CLIA and CAP programs look at quality from a micro perspective; both have rigor, but at different levels. Another way to explain the difference is that CLIA evaluates how a lab runs tests, while ISO 15189 looks at how the lab runs the overall laboratory operation. CAP checklists have rigor in the detail of regulatory requirements and good lab practices, as espoused by CAP, including competency assessments and proficiency testing. A CAP checklist details how to perform a process quite specifically, whereas ISO 15189 seeks to inform the processes from a broad perspective. In addition, ISO 15189 spells out best practices for managing all systems that affect quality and competence in the lab. Unlike a CAP checklist, it is not specific to any particular specialty; rather, it covers the entire lab and its QMS as a whole.

Focus on the Fundamentals

Required elements of a QMS are spelled out in CAP checklists and other regulatory edicts, but resist the urge to get carried away with complicated, obscure aspects of quality from the onset; a strong QMS is necessary for success and starts with a sturdy foundation. Quality systems and approaches should be both specified and efficiently implemented to be effective; most failures occur in execution. Management cannot take for granted that a written policy or procedure is being practiced. Therefore, the impetus is on the lab or quality manager to assess through auditing the various levels of conformance to the QMS as designed and to the ISO 15189 standard. It is easy to get upset when clear, concise, and well-thought-out policies and procedures are not effectively implemented or not followed at all. However, failures in execution likely reflect failures in proper leadership. Staff may not have been trained sufficiently, or the process design may not fit with the laboratory’s workflow. All quality programs should be customized to the individualized needs of a given laboratory. The following are fundamental elements of the QMS that should not be overlooked:

•Environmental monitoring (eg, temperature, humidity)

•Quality control review

•Complaint and concern management

•Document and record control, including review and retention

•Management involvement, including a comprehensive, balanced set of management review metrics

•Inventory management

•Execution of policies and procedures in the laboratory (practice often does not match procedure)

•Allocation of space and resources

•Service agreement (contract) review to assess capacity to take on new business

•Internal auditing program, including auditor training and a schedule appropriate to services offered, that focuses on areas appropriate for improvement

•Non-conforming event management (to include failures and deficiencies on any of the above items) that enables investigation, root cause analysis, corrective and preventive action (CAPA), and effectiveness checks

Approach

There is no single best approach to complying with the requirements of ISO 15189. Each lab is unique and the systems designed to address the requirements should meet the individual needs of each organization. What works for your lab may not work for another. What is important is that the laboratory starts on a quality journey with the aim of best practice and continuous improvement for the benefit of its patients, clients and employees. Compliance with a “quality assurance” mindset of just meeting minimum requirements is no longer sufficient. I would argue that this approach has never been sufficient if the best quality care of our patients is part of a lab’s organizational mission. For success in an ISO 15189 program, it is crucial that the leadership not aim to just “tread water” within the structure of the QMS deployed. If the laboratory’s quality program becomes stagnant, the laboratory becomes obsolete both for its patients and their safety, but also in the market.

Broadcasting Success

Quantifying the results of implementing ISO 15189 is crucial, as it demonstrates the value of the effort to an organization and its patients. Demonstrating success is necessary for the sustainability and continued support of the initiative. Success can be quantified through gains in efficiency, improvement on quality metrics, return on investment (ROI) through financial savings, and the calculation of cost-of-poor-quality (CoPQ) savings. Keep in mind that labs must establish a quality baseline in order to gauge achievements and positive outcomes. Likewise, broadcasting the effectiveness of the lab’s QMS and its processes within the organization is a requirement of accreditation to the ISO 15189 standard. Certainly, successful quality improvements should be celebrated in this manner, and any setbacks should be reinforced with education and course adjustment if results are not realized. Methods for internally broadcasting success include presentations, memos, newsletters, dashboards, and reports distributed to staff and executives within the organization. Externally broadcasting success also can bring more attention to an organization’s successful quality efforts, and this includes presenting posters, giving talks at conferences, and publishing articles. In addition to the inherent value of internally analyzing program success, there are a number of additional benefits to measuring and sharing success. Selling executive and medical leadership on the value of a continuing ISO 15189 initiative can be a challenge without data demonstrating ongoing ROI and benefit to patients. National Jewish Health’s Advanced Diagnostic Laboratories were able to gain full support when data was presented indicating the laboratory’s ISO 15189 initiative achieved an 84% reduction in CoPQ, realizing just over one million dollars in cost savings over the course of a year⁶. Visual representation of success also is extremely effective in keeping staff motivated and engaged in ensuring quality.

Conclusion

As reimbursement shifts from fee-for-service to value-based purchasing, quality is becoming a focal point in healthcare. The ability to demonstrate a laboratory’s commitment to quality and patient safety allows the laboratory to thrive and stand out amongst competitors in an ever-changing environment. Patients and ordering providers demand transparency for healthcare services and are beginning to use data on quality performance to drive their decisions. Large well-known clinical laboratories with reputations for excellence such as ARUP, Lab Corp, Sonic Healthcare and Henry Ford have become accredited to ISO 15189 over the past few years, sending the message that accreditation to ISO 15189 is an independent validation of a laboratory’s quality and is perceived as relevant and worthwhile by these heavy hitters. I believe that laboratories looking to demonstrate that they are top tier organizations will continue to pursue this accreditation. Recently, ISO 15189 has become a requirement for some laboratories providing services for clinical trial research, prompting organizations such as Covance and Q Squared Solutions to achieve the accreditation at multiple locations internationally. ISO 15189 conformance has been credited with improving laboratories from a business perspective as well. Avera McKennan Hospital Laboratory in Sioux Falls, South Dakota, the first hospital laboratory in the US to achieve CAP 15189 accreditation, credits the accreditation for helping them to secure a half-million-dollar contract and additional outreach work⁷. National Jewish Health in Denver, Colorado published a paper in demonstrating a cost savings and cost avoidance of over a million dollars in non-conforming events credited to the ISO 15189 framework and accreditation process⁶. In the United States, I expect to see increasing adoption of ISO 15189 and more laboratories achieving accreditation in the future as has been seen over the last 5 years with the number of laboratories accredited to ISO 15189 doubling. Accreditation to the standard however is not necessary to reap the quality, patient safety and financial benefits associated with implementation of a quality management system. Working towards conformance to the standard will provide those benefits to any laboratory willing to put in the work. Accreditation is the cherry on top, providing external validation your laboratory conforms to the highest standard and providing the subsequent reputational benefits. Navigating the seemingly uncharted waters of ISO 15189 now will help position your laboratory for success in the future as quality continues to become an increasingly meaningful differentiator.

Acknowledgement: David Wolfe, Former CAP 15189 Lead Assessor

References

1. International Organization for Standardization, ISO 15189: Medical laboratories - requirements for quality and competence. Geneva, Switzerland. 2012.
2. College of American Pathologists, CAP 15189 Frequently Asked Questions, https://documents.cap.org/documents/2016-iso-15189-faqs.pdf, Accessed 8/11/2019.
3. Schneider F et al. International Organization for Standardization (ISO) 15189. Ann Lab Med. 2017 Sep; 37(5): 365–370.
4. American Association for Laboratory Accreditation, Frequently Asked Questions Related to the A2LA ISO 15189 Medical Laboratory Accreditation Program, https://www.a2la.org/accreditation/clinical-testing, Accessed 8/11/2019.
5. Outcome Engenuity, Just Culture, https://www.outcome-eng.com, Accessed 8/11/2019.
6. Dawson J et al. Journey to ISO 15189. Clinical Leadership and Management Review. Volume 28, Issue 4, Quarter 2 2014.
7. Ford A. ‘We wanted to be the best we could possibly be’: CAP ISO 15189-accredited labs on the difference it makes. CAP Today. September 2018. https://www.captodayonline.com/wanted-best-possibly/