January 2009 Clinical Laboratory News: ISO Accreditation Comes to America

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January 2009: Volume 35, Number 1

ISO Accreditation Comes to America
Are Labs Ready to Embrace an International Quality Management System?
By Bill Malone

In September, Norway-based DNV Healthcare became officially recognized as a national accreditation organization for hospitals, the first new player in hospital accreditation in 40 years. On top of breaking into the venerable circle of accrediting bodies, the organization also brought something new to the shores of the U.S.: hospital accreditation based on compliance with the ISO 9001 quality management standard. Meanwhile, CAP, the second largest lab accrediting organization, recently rolled out an optional accreditation program based on the ISO 15189 standard for medical labs, creating a buzz among industry observers that the U.S. healthcare system—including labs—should brace for an ISO invasion. Governments and industries around the world have been using international standards for more than half a century to facilitate trade, establish a technical base for regulation, and safeguard consumers. Now it appears that more clinical labs will start looking toward medical lab-specific ISO 15189 accreditation, hoping to take advantage of a customized quality management system (QMS) that carries the prestige of the ISO label.

Glen Fine, executive vice president, Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS), which holds the secretariat through 2009 for the ISO committee that develops standards for labs, thinks the time has come for labs to take notice of quality management systems like the ISO standards. “The world is getting smaller, and it’s hard to ignore it,” said Fine. “The IVD industry that supports labs adopted quality management system principles years ago. So you have industry which has adopted it, you have an international groundswell moving in this direction, and you have CMS which positively views labs that adopt a QMS approach to meeting CLIA requirements. In the worst case, organizations don’t want to be left behind. In the best case, they want to be early adopters.”

The ISO Umbrella

While at the helm of Beaumont Reference Laboratory in Detroit, Joseph Skrisson was one of the early adopters of ISO standards for clinical labs. In the late 1990s, he was looking for a way to organize his staff under a quality management system (QMS) that went beyond the lab’s traditional CAP accreditation and covered areas like documentation control, billing, and couriers. At that time, the lab-specific 15189 document hadn’t been written, which meant more work on his lab’s part to apply the more generic ISO 9001 standard to its particular needs. However, Skrisson knew that because ISO standards were well known in other industries in the Detroit area, more of his customers would recognize an ISO certification as a stamp of quality. This could mean a competitive advantage. “In Detroit, a city heavily into the automotive industry and manufacturing, the Big Three automobile manufacturers send a lot of patients to physician offices,” said Skrisson. “A lot of the auto suppliers and many of the manufacturing companies used ISO already. So when you can say you’re ISO accredited, that means something to them. It means quality in a language they understand.”

Now the CEO of Piedmont Medical Laboratories (Winchester, Va.), Skrisson recently headed up his lab’s effort to become the first lab to complete the new CAP 15189 program that accredits clinical labs to the ISO standard. Skrisson explained that when he came to Piedmont in 2004, the lab didn’t have a good quality management system in place. Based on his experience in Detroit, Skrisson believed that using ISO would again be a good way to implement quality management and process improvement, and get documentation under control. Now having become the first U.S. lab to fully implement and be accredited under the CAP 15189 program, Skrisson said Piedmont is already seeing significant achievements and positive customer feedback that he credits to adhering to the ISO standard.

The core benefit of using ISO 15189 comes from following its comprehensive and highly structured approach for quality management, while also allowing labs to employ tools like Lean or Six Sigma, explained Cordelia Sever, MD, FACP, chair of CAP’s new accreditation program. “The management requirements are quite broad, and it’s really suited to be an umbrella for any kind of quality system that you want to plug in there,” she said. “That’s one of the things that’s very sketchy in the CLIA standards—some components are there, but it’s not as rigorous and systematic as the ISO standards.”

ISO 15189 Overview

The ISO 15189 standard, designed specifically for medical laboratories, covers 15 management requirements and 8 technical requirements. The standard is concise and to the point, with each section consisting of anything from a few sentences up to several pages of explanation.

Management requirements

Technical requirements

Organization and management

Quality management system

Document control

Review of contracts

Examination by referral laboratories

External services and supplies

Advisory services

Resolution of complaints

Identification and control of nonconformities

Corrective action

Preventive action

Continual improvement

Quality and technical records

Internal audits

Management review


Accommodation and environmental conditions

Laboratory equipment

Pre-examination procedures

Examination procedures

Assuring quality of examination procedures

Post-examination procedures

Reporting of results

Getting Accredited

ISO 15189 involves an across-the-board review of the clinical lab, with 15 management requirements and eight technical requirements aimed at areas like continual improvement and technical competency. At only 40 pages, ISO 15189 might appear to be a do-it-yourself program (See Table, above). However, Sever made it clear that it’s not always easy to understand what the standard is asking the lab to do. “Because it is a very cut-and-dry document, it’s not really rich in explanatory language,” Sever explained. “Reading the standard and understanding what it really means are two different things. So having the actual assessment by the certified assessors makes people understand what the expectation is and what the intent is of the standard.”

Sever also emphasized that an accreditation program like CAP’s helps keep labs on track through coaching to sustain gains and keep from losing ground. She believes that an ISO accreditation program strengthens a lab’s commitment to the process. “It gives some urgency and value to the whole thing and infuses discipline into the processes. It also accelerates your progress, because if you don’t have any established goals and external checkpoints, with everybody busy all the time, it’s easy to slip back.”

Under a 15189 accreditation program, one of the most important steps is the gap analysis. This takes place after the lab has purchased the 15189 document from ISO and has conducted a preliminary internal audit of its processes. During a gap analysis, assessors look in detail at where the lab falls short of the ISO standard and reveals what the lab needs to work on most. “The labs we have worked with so far say that a gap assessment is really quite critical,” said Sever. “They say the gap assessment should be a requirement for accreditation. However, because it’s not required by the ISO standard, it’s still an optional cycle.”

After the gap assessment, Sever also recommends a pre-assessment from CAP, which takes place within 90 days of the final accreditation assessment. The pre-assessment is a trial run that gets the lab ready for its own final internal audit, followed by the final accreditation assessment. The pre-assessment usually follows up on gaps that were previously identified and is a fairly short visit, Sever explained. Once the lab passes the final accreditation assessment, a 3-year cycle begins. In the first and second years, two surveillance assessments are scheduled; during the third, onsite reaccreditation is required (See Figure).

Challenges and Benefits

According to Sever, those labs working toward their ISO 15189 accreditation with CAP usually point to the document control requirement as the most onerous. Basically, every process and procedure must be written down, properly organized, and followed to the letter. “In other words, with ISO, if you don’t have it documented, if you don’t have a procedure, you don’t do it,” said Skrisson. “There are no verbal procedures or hand-me-downs. But that’s one of the real strengths of the system.” Skrisson stressed that once his lab got this right, it was able to reap some of the greatest benefits from this area. To streamline the process, he chose to go with electronic documentation, because it made it easier to update procedures any time there was a change and stay in compliance with the ISO requirements. “That was a great improvement because you could go online at any time and access the policy or procedure for a particular workflow or operating standard in the lab,” he said.

Another challenge comes from the requirements aimed at process improvement, which is really the center of the ISO approach. The 15189 ISO standard not only requires that a lab seek continuous quality improvement, but also take proper corrective and preventive actions, which boils down to root cause analysis, according to Sever. “Root cause analysis is still surprisingly shallow in the standard lab arena, and the ISO standard really mandates a more in-depth and appropriate level.” One tool useful in targeting preventive action is “five why analysis,” which pushes a lab to investigate progressively deeper into the cause of a problem or a non-conformity to the standard. “This idea of corrective and preventive actions, and a scheduled review of effectiveness of those actions, all feeds into continuous risk assessment embedded in the system,” said Sever. Skrisson found that the bottom line of process improvement is getting staff to consistently look ahead for pitfalls and implement corrective measures. For example, instead of using a staffing shortage as an excuse, the lab worked on developing a plan that made sure that if someone was out, the operation could carry on without interruption. “What ISO really drives you toward is making certain that the product you deliver every day to your customer is consistent, high-quality, and never changes no matter what challenges you have in operations,” Skrisson said.

Experts in ISO 15189 accreditation emphasize that getting buy-in from managers and staff is key. “You have to convince the top administration that ISO accreditation is worth the effort,” said Daniel Périgo, RPh, the integrated management system coordinator at Fleury Diagnostics (São Paulo, Brazil). He is also responsible for the lab’s Sustainability department (quality, environmental, and social projects), and frequently presents programs on the ISO certification process. “I think perhaps the greatest difficulty is resistance to change. In implementing a quality system and standardizing processes, we have to change the way people are used to working. And that can have some resistance if not everyone is convinced this is a good thing for the lab.”

Périgo also said that labs frequently wrestle with defining indicators, as required under ISO 15189’s continual improvement section. The standard states that “laboratory management shall implement quality indicators for systematically monitoring and evaluating the laboratory’s contribution to patient care. When this program identifies opportunities for improvement, laboratory management shall address them regardless of where they occur.” Often the lab can define indicators that are good for monitoring a process, but not as good for management purposes, said Périgo, which can make it hard to prove that implementing the ISO standard is useful to achieve financial, customer satisfaction, and market share goals.

Skrisson said that while it did take some time to get his staff trained for ISO 15189 accreditation, the program also got his staff asking questions about why they did things they way they did, and then started pushing for improvements on their own. “People at the bench level really drive most of the changes,” said Skrisson. “Every day they see the flaws in the system. As the staff starts buying into it, you hear comments like, ‘Wow, I’m glad we finally changed this, because it never made any sense but we did it this way for years.’ ”

Périgo also reiterated Sever’s view that ISO 15189 gives a lab a more complete picture of its operations. “Our experience in Brazil is that the main advantage of the ISO standard is that it looks at the process as a whole. You don’t only look at the technical aspects of the work, at the bench level. It also makes the quality system more visible to managers, to the top administration of the lab, or to the hospital administration for a hospital lab.”

The Alternative Approach

Since 1995, CLSI, a U.S.-based international lab standards organization, has served as the ANSI-designated executive secretariat to the ISO technical committee TC212, Clinical Laboratory Testing and In Vitro Diagnostic Test Systems. The committee includes representatives from 33 countries, and, over the last 15 years, it has produced 19 international standards, including ISO 15189, on subjects such as point-of-care testing, quality management, and safety in medical laboratories. Other committees produce standards for reference laboratories and medical devices. In fact, IVD manufacturers have been using ISO standards for decades, as most companies market their products in Europe and around the world, where ISO “carries great clout,” said CLSI’s Fine. “As soon as you cross borders, you’re likely to run square into 15189.”

In addition to its support of the ISO standards process, CLSI has developed its own quality management system, a program that is also internationally applicable for different countries. Similar to ISO 15189’s 15 management requirements and eight technical requirements, the CLSI QMS is built on 12 Quality System Essentials. There is some overlap between the two systems, but each has its own distinct take on implementing the QMS. “If your lab fully adopts a quality management system approach, either system will get you to a good endpoint,” said Fine. “The difference is that the ISO model is very general, whereas the CLSI system tends to be more specific and implementable.” The CLSI system is based on two documents: HS1, A Quality Management System for Healthcare and GP26, Application of a Quality Management System Model for Laboratory Services. Unlike the ISO 15189 standard, labs can acquire CLSI’s complete QMS in a bundle called “The Key to Quality,” a package intended for labs implementing a quality management system on their own. Broadly, HS1 discusses CLSI’s 12 Quality System Essentials, while GP26 covers the path of workflow approach. In addition, all of CLSI’s libraries of more than 200 standards and guidelines have a degree of interrelatedness with these two primary QMS guidelines.

According to Fine, many U.S. labs will likely identify with the CLSI model more readily than ISO’s. “The CLSI system is easily understood and it’s something you can take and layer into your CLIA requirement,” said Fine. “As an internationally applicable standard, ISO 15189 is intentionally very broad and overarching, and it’s a document intended to be adapted to fit national or regional lab needs.”

Part of the reason the CLSI standard is more specific arises from the way CLSI develops its guidelines. CLSI gathers experts from government, industry, and professionals with the aim of “putting the best minds in the room,” said Fine, and the process is open to all interested parties, regardless of their geographic location and with no limitations on the number of people from a single country. With ISO, only one officially designated member body from each country can participate in the voting process. This comes from ISO’s primary mission to reduce trade barriers, explained Fine. “ISO’s primary focus is on standardizing industry, commerce, and trade, whereas CLSI is focused exclusively on developing best practices in the clinical and laboratory fields for practicing professionals, industry and government.” As to whether CLSI’s model is competing with the ISO 15189 standard, Fine said he looks at it as “The two systems are complimentary. I don’t necessarily see it as choosing one over the other. Factors including regulatory requirements, complexity of the lab setting, and culture all play a factor in the decision process.” Regardless, a lab clearly has some homework to do before it decides to go with one system or the other.

CLIA Still Rules in the U.S.

Even though many countries around the world have adopted ISO standards as the national basis for regulatory and accreditation of clinical labs, at this point, CMS is not ready to make ISO standards a required part of lab accreditation under CLIA. According to Judith Yost, MA, MT (ASCP), director of CMS’s division of laboratory services, ISO 15189 requirements are too general and, in some cases, not as stringent or specific as CLIA regulations. For example, ISO 15189 requires that the lab have a competent laboratory director, but CLIA spells out explicit education, training, and experience requirements, as well as clear-cut responsibilities for this position that aren’t part of the ISO 15189 standard. “Certainly you can see principles and concepts of CLIA within the quality standard of ISO 15189, but it’s so broad-based that in many cases it’s just not equivalent to our regulations,” said Yost. “You have a standard that’s written for 35 different countries, so to be able to articulate that specificity isn’t an easy task, which is why they leave it up to individual countries to determine what they want to do with it.”

A member of TC212 technical advisory committee that wrote ISO 15189, Yost stressed that while CMS can’t accept ISO standards as a stand-alone measure to satisfy CLIA requirements, the agency does support and encourage labs to take a quality management system approach. “I think there are plenty of examples of labs that have used the CLSI documents and ISO standards who’d tell you that they now work smarter, not harder, and that they produce a higher quality work as a result of implementing those standards in their laboratory,” Yost said. She also noted that because CLIA covers more than 200,000 labs, smaller or less sophisticated organizations would have a hard time applying something as comprehensive as ISO 15189.

More Changes Coming

In the same way that DNV has shaken things up by breaking onto the hospital accreditation arena and requiring ISO 9001 adherence, the American Association for Laboratory Accreditation (A2LA, Frederick, Md.) hopes to make waves when it earns deemed status to accredit labs in the first quarter of this year by offering ISO 15189 in addition to accreditation to CLIA. A2LA has already begun accrediting medical labs to ISO 15189 internationally, beginning with a lab in Aruba. According to Roxanne Robinson, vice president of A2LA, the organization knows of a number of medical laboratories that have been waiting for A2LA to achieve deemed status under CMS and switch from another accrediting body. “We do have labs waiting in the wings for this,” said Robinson. “They’ve expressed a lot of interest in ISO 15189, and they know that we’re internationally recognized as having worked with ISO standards for a very long time.”

Robinson stressed that she feels U.S. labs are lagging behind the rest of the world in adopting the ISO 15189 standard. “Business is becoming global, and the U.S. cannot be U.S.-centric anymore,” she said. “I think the medical community is finally understanding this, that if they want to compete internationally, at the same level as their peers, they have to look at a global process for determining competence.”

Skrisson also emphasized that he hopes ISO standards will become a way for leaders from labs around the world to sit down and be able to share best practices around a common set of ideas. “I’m looking forward to one day getting together with colleagues from Australia, Japan, China, Africa, and talking about lab challenges and emerging technologies, and putting it all under a universal program where we’re all talking the same language regarding quality and competence in our laboratories.”

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