First U.S. Labs Nearing ISO:15189 Accreditation

ISO:15189 likely to influence upcoming reform and revisions to CLIA licensing requirements

CEO SUMMARY: Laboratories, hospitals, and other health-care providers in the United States will increasingly be required to adopt quality management systems (QMS) as part of their regular operational routine. This is consistent with trends in other developed countries. Several U.S. laboratories are in the process of gaining accreditation under “ISO:1519 Medical Laboratories.” These developments will be discussed at the upcoming Lab Quality Confab in Atlanta next month.

WITHIN THE NEXT 12 WEEKS, it is likely that the United States will have its first ISO:15189–accredited laboratory. As you read this, three laboratories in the United States are making steady progress toward accreditation under ISO:15189 Medical Laboratories.

It is likely that few pathologists and laboratory managers will take notice of this fact. Yet, the first ISO:15189 accreditations in the United States will be a significant event for this country’s laboratory industry.

That’s because ISO:15189 has the potential to shoehorn its way into the laboratory licensure and accreditation structure in the United States. To be sure, this won’t happen overnight. But there are powerful forces at work in healthcare and laboratory medicine that have one thing in common: providers, including laboratories, hospitals, and even physician groups, will need to use quality management systems (QMS) to maintain accreditation, licensure, and eligibility for reimbursement.

In fact, odds are good that the impending reform and updating of CLIA (Clinical Laboratory Improvement Act) standards will include a requirement that, to maintain status as a CLIA-licensed laboratory, the candidate laboratory must demonstrate its effective use of quality management systems in its daily operations. Officials from CMS have stated publicly that their intent is to incorporate use of quality management systems into the next generation of CLIA requirements.

For that reason alone, laboratory directors and pathologists in the United States will want to pay closer attention to quality management systems. Within just a few years, renewal of their laboratory’s CLIA license will probably require effective deployment and use of a quality management system.

Even if the concept of a quality management system (QMS) is new to most lab directors and pathologists, it has been around for more than 12 years in the medical device industry. In 1996, a new federal law and supporting regulations took effect. Medical device manufacturers, including in vitro diagnostic companies, must use good manufacturing practices (GMPs) and follow the Quality System (QS) requirements of the Food and Drug Administration (FDA). This is an example of how quality management system requirements are already working their way into healthcare regulatory requirements here in the United States.

On the ISO:15189 front, THE DARK REPORT is aware of two organizations currently offering this accreditation to help laboratories. One is the American Association for Laboratory Accreditation (A2LA), based in Frederick, Maryland. The second is the College of American Pathologists (CAP), located in Northfield, Illinois. (See TDR, March 3, 2008.)

Secretariat For TC 212

Another laboratory organization that has both long experience and deep involvement in quality management systems is the Clinical and Laboratory Standards Institute (CLSI) in Wayne, Pennsylvania. It has the unique honor of being the Executive Secretariat for Technical Committee 212 (TC 212) of the International Standards Organization (ISO). TC 212 is responsible for developing and publishing more than 20 ISO standards relating to medical laboratories and IVD products, including ISO:15189. (See TDR, June 16, 2008.)

Because of these unique perspectives, Glen Fine, CLSI Executive Vice President and Chief Staff Officer, will speak at the upcoming Lab Quality Confab on how quality management systems are driving major changes in laboratory accreditation and licensure, both here in the United States and globally. Lab Quality Confab will take place in Atlanta, Georgia, on September 24-25, 2008.

Contribution To Lab Success

Because of the growing contribution of quality management systems to the successful operation of clinical laboratories and pathology group practices in the future, there will be other important presentations at Lab Quality Confab on quality management systems in general and ISO:15189 Medical Laboratories in particular.

For example, since 2003, Canada’s Ontario Province has mandated that laboratories must be accredited under ISO:15189. By year end, more than 200 laboratories in Ontario will be ISO:12589–accredited. To share the lessons learned from the accreditation process, Ruth Jaeger, General Manager, Eastern Ontario Regional Laboratory Association in Ottawa, will make a presentation at Lab Quality Confab. Following this session, attendees will hear from one of the first laboratories in the United States actively working to achieve ISO:15189 accreditation. At Piedmont Medical Laboratories, Inc., of Winchester, Virginia, Benita Haines, Quality Management, Compliance & Education Coordinator, will explain why the laboratory made the decision to become ISO:15189–accredited and share the lessons it is learning.

Another tool of quality management systems that is already a requirement for hospitals—and may be incorporated into laboratory licensing requirements—is FMEA (Fault Mode and Effects Analysis). Since 2005, The Joint Commission has required hospitals to conduct at least one FMEA project each year. From Abbott Diagnostics of Abbott Park, Illinois, Tina Krenc, Director, Diagnostics R&D Phase System, will be at Lab Quality Confab to explain FMEA and FTA (Fault Tree Analysis). These are established systems used to identify, in advance, sources of systemic failure and risk in an organization’s work flow and individual work processes.

Since QMS is also working its way into laboratory proficiency testing (PT), Lab Quality Confab will feature a presentation on that topic by Michael Noble, M.D., FRCPC, Chair, Program, Office for Lab Quality Management, University of British Columbia, Vancouver, British Columbia. Because of widely publicized lab testing deficiencies that surfaced in recent years in Canada, Noble’s first-hand experience at developing proficiency testing programs that address quality problems will be of particular interest. (See pages 16-18 in this issue.)

Spotting Trends Early

Our long-time clients and readers know THE DARK REPORT has a credible track record at being first to identify many important trends in laboratory management, often in their earliest stages. Armed with that knowledge, labs and pathology groups have had the time and foresight to establish winning strategies in response to these trends.

It is happening now with quality management systems. This trend is in its early phase, giving lab managers and pathologists time to develop strategies and effective responses. Adoption of quality management systems will move forward at a steady pace, particularly as regulatory bodies incorporate QMS into licensing and accreditation requirements.

The collection of speakers and presentations on QMS at Lab Quality Confab will be the first time that so many primary players will be together at one time to discuss this topic. That makes it a unique opportunity for lab leaders to get the full picture, as well as to meet and network with these experts.

A final word on the arrival of quality management systems into laboratory operations. With the emphasis on improving patient safety, reducing medical errors, and improving quality, labs cannot rely on the management methods of the 1980s and 1990s. It is no coincidence that Lean, Six Sigma, ISO:15189, and other approaches are gaining acceptance in the laboratory profession. Labs are already using these methods to achieve levels of productivity and quality unimagined just a few years ago.

Quality Management Systems Coming to Lab Profession

MANY LAB DIRECTORS AND PATHOLOGISTS remain unaware of quality management systems (QMS) and the role these organizational tools have in transforming how healthcare organizations, including laboratories, conduct their affairs.

Wikipedia defines quality management sytems “as a set of policies, processes and procedures required for planning and execution (production / development / service) in the core business area of an organization. QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance.”

For laboratory managers, the key insight is that quality management systems are, by design, a comprehensive methodology that requires laboratories and other organizations to be operated with a specific philosophy. Additionally, with hospitals, laboratories, and other healthcare providers being asked to produce products and services where defects and errors are measured in events-per-million, quality management systems have the tools, methods, and capabilities to help organizations achieve these remarkable levels of quality.

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