Although the term likely is familiar, many 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 been given the directive to implement ISO 15189 and you do not know where to start. I came into a new position as a quality manager for a complex, esoteric reference laboratory and was asked to prepare the entire laboratory for a CAP 15189 surveillance in 6 months. If this scenario sounds familiar, you are not alone. 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.

Quality is a Journey
First and foremost, lab management should understand that effective implementation of ISO 15189 is an ongoing journey, not a destination. The technologies and best practices of laboratory operations are ever-evolving, so there is always room to improve quality. The goal at all times should be to provide the highest quality laboratory services possible, recognizing that this goal remains a moving target.

Lab managers across the country may feel they are not prepared for the scrutiny of ISO 15189 and have years of quality management systems (QMS) improvements to accomplish before applying. However, CAP assessors do not expect perfection from the outset. During the initial review, assessors seek to determine whether the laboratory has at least the basic structure in place to appropriately address each requirement, as well as systems for addressing unexpected outcomes or situations. That said, there are opportunities to assess a facility’s readiness for the initial onsite accreditation review built into the CAP 15189 accreditation process, including a gap analysis. 

Both practitioners and assessors expect the different components of a QMS to evolve and improve over time, but formally embarking on the journey to accreditation helps in setting deadlines and creating accountability for the implementation of quality improvements that may otherwise fall by the wayside. As the saying goes, all journeys begin with a single step, so 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 a minimum level, that laboratory should move forward by submitting their application. Because of the voluntary nature of accreditation, the assessments are not punitive in any way. Instead, they are collaborative and conducted in the spirit of continuous quality improvement. Assessors are acutely aware that every lab has to start somewhere. The staff buy-in, commitment, and momentum achieved simply by entering into the CAP 15189 accreditation process are substantial.

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.¹ 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 thinking. 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 requires operational initiatives that supersede the basic checklist mentality. For example, instead of requiring staff to record periodic temperatures for a refrigerator unit, ISO 15189 requires that lab staff understand the intent behind recording the temperatures in order to act proactively. An ISO 15189 approach is patient-centered; quality efforts are not performed to conform to a checklist, but instead to provide the highest level of quality for our patients.

It is important to reinforce the reality that each specimen represents a person’s life, and every patient deserves the best possible care. Highlighting the intent of the ISO 15189 standard and its requirements helps staff gain a true understanding of the purpose of the program. Highlighting the safety benefits to patients and staff enabled by adopting ISO 15189 helps humanize the initiative and gain staff buy-in, loyalty, and dedication. 

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. 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 a QMS 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 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

As each laboratory operation is unique, there is no single best approach to conform to the requirements of ISO 15189. What works for one lab may not work for another. Fortunately, the standard can accommodate any lab operation, but the traditional quality assurance mind-set of aiming to meet minimum requirements is not sufficient to deliver the level of care demanded by, and owed to, our patients. For an ISO 15189 program to be successful, lab leadership must embrace the idea that the QMS is an ever-evolving entity. If the laboratory’s approach to quality becomes stagnant, the QMS will become obsolete. What is important is that the laboratory starts on a quality journey with the aim of using best practices and continuous improvement for the benefit of its patients, clients, and employees.

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. In our experience, we were able to gain full support when we presented data 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 year.2 Visual representation of success also is extremely effective in keeping staff motivated and engaged in ensuring quality. 

As reimbursement shifts from fee-for-service to value-based purchasing, quality is becoming increasingly important. The ability to demonstrate a laboratory’s commitment to quality and patient safety allows the laboratory to thrive in an ever-changing environment. Navigating the uncharted waters of ISO 15189 now will help position your laboratory for success in the future as quality becomes an increasingly meaningful differentiator.

References

1. International Organization for Standardization. ISO 15189: Medical laboratories - requirements for quality and competence. Geneva, Switzerland. 2012. 
2. Dawson J. Journey to ISO 15189. Clinical Leadership and Management Review. Vol 28; Q4 2014.

The author would like to thank David Wolfe, CAP 15189 lead assessor, for his contributions to this article.

Jennifer Dawson, MHA, DLM(ASCP)CMSLS, QIHC, is the vice president for quality and regulatory affairs for Sonic Healthcare USA in Austin, Texas. She is responsible for oversight of a corporate approach to robust, best practice quality management systems and regulatory conformance for all SHUSA affiliate labs nationwide. She sits on the CLMA Board of Directors, the ASCLS Patient Safety Committee, and the National Malcolm Baldrige Quality Award Board of Examiners. Jennifer’s areas of interest include ISO 15189 deployment, real-time quality metrics, cost of poor quality, electronic management of non-conformities, and quality in the pre-analytical phase. She also is interested in collaboration with other laboratory administrators on research projects and publications.

SIDEBAR
ISO 15189 Basics
At its core, ISO 15189—an international standard based on ISO/IEC 17025 and ISO 9001—specifies requirements for quality management systems (QMS) and competence in the medical laboratory. To date, the International Organization for Standardization (ISO*) has released three versions of the standard: the first came out in 2003; an update was released in 2007; and a third version released in 2012—ISO 15189: Medical laboratories – Requirements for quality and competence—is the current version in use. The standard now is usually regarded as ISO 15189 without reference to a specific version.¹

Since its introduction, ISO 15189 has become an international standard of excellence for quality management in medical labs. The patient-centered standard blankets the continuum of care by promoting patient safety, risk mitigation, and operational efficiency.¹ Thus, the overarching goal of the standard is global harmonization of medical practices through efficient information exchange (including data protection) in order to ensure the health and safety of both patients and providers. To this end, clinical laboratories, regulatory authorities, and accreditation bodies commonly use the ISO 15189 standard to help gauge quality and competence.²

It is important to keep in mind that accreditation to the ISO 15189 standard is voluntary in the US and does not replace a laboratory’s College of American Pathologists’ (CAP) accreditation through the Laboratory Accreditation Program, or the federal Clinical Laboratory Improvement Amendments (CLIA) certification.1 However, as of now, CAP and the American Association for Laboratory 

Accreditation (A2LA) offer accreditation to the ISO 15189 standard in the US. (The Web sites of both organizations contain information on their respective accreditation processes; both accredit to the ISO 15189 standard.) Implementation of, and accreditation to, the ISO 15189 standard is meant to complement and bolster existing certification, accreditation, and quality management systems.

References

1. College of American Pathologists. CAP 15189 Accreditation Program; Frequently Asked Questions. www.cap.org/ShowProperty?nodePath=/UCMCon/Contribution Folders/WebContent/pdf/15189-faqs.pdf. Accessed 6/18/2015.
2. American Association for Laboratory Accreditation. Frequently Asked Questions Related to the A2LA ISO 15189 Medical Laboratory Accreditation Program. www.a2la.org/faq/medical_15189.pdf. Accessed 6/18/15.

*What’s in a Name?
It is a common misconception that ISO is an acronym for the International Organization for Standardization. The name ISO actually is derived from the Greek word isos, meaning equal. The organization wanted to establish one common name across all three of its official languages (English, French, and Russian). Because an acronym would have been different in all three languages, the decision was made to adopt the short name ISO, which is a registered trademark.
See: www.iso.org/iso/home/about.htm