Tools, Technologies and Training for Healthcare Laboratories

Guest Essay

Quality Management Cocktail ISO, Lean, and Six Sigma

Sten Westgard provides a report on a presentation from three experts on three different quality management trends. Different approaches are discussed, areas of convergence are described.

August 2005

Looking for light at the end of the CLIA tunnel

Any honest survey of current US regulatory guidelines for the healthcare laboratory might want to include one word: chaos.

The “Final” part of the CLIA Final Rules is increasingly a misnomer – the first three EQC options became obsolete even before they came into effect, and the fourth option remains a tantalizing mystery. When the fourth option arrives, expect calls for a fifth option, and a sixth, until all the special interests have been satisfied. It is obvious to all by this point that CLIA's true goal is not to establish any standards of quality, but to ensure that no laboratory – or Point-of-Care device - is left behind.

Meanwhile, the deemed accreditation providers are operating under a cloud. Dramatic failures in the news (Maryland General at the top of the list) have revealed deep flaws in the accreditation systems. A forthcoming report by the Government Accountability Office (GAO) is not expected to be kind, and may throw their organizations into disarray.

Even discounting the known failures of the inspection and accreditation organizations, we have seen a recent surge in new regulations. Patient Safety guidelines are being issued at an accelerating pace. Checklists seem to change not just every year, but every quarter. Keeping up with these changing requirements, and staying in compliance with them, is a thankless, wearisome job. Every new requirement and policy and interpretation is dissected on email listservs, discussing how many data points must be fit on the head of a pin before an inspector will be satisfied.

Given this confusing, mercurial landscape, it's no wonder that laboratories are looking elsewhere for guidance. The US regulatory universe has grown into a Ptolemaic system, full of requirements epicycles, and we may need new models for solutions.

With this hope in mind, I was very interested to attend a particular Edu-Trak at the AACC convention: Quality Management in Clinical Laboratories through ISO Standards, Six Sigma, and Lean Manufacturing Principles

This sesssion, moderated by James E Love, Jr., PhD, DABCC, Ortho-Clinical Diagnostics, Rochester, NY, included three presentations by experts in their respective quality management areas:

  • ISO Standards in the Clinical Laboratory: the Basics for Successful Implementation
    Rogerio Rabelo, MD, PhD, MBA, Fleury Diagnostics, Sao Paulo, SP, Brazil
  • Application of Six Sigma in the Clinical Laboratory
    Carl Garber, PhD, FACB, Quest Diagnostics, Lyndhurst, NJ
  • Improving Your Laboratory Operations with Lean Manufacturing Principles
    Maureen Harte, MT (ASCP), Six Sigma Master Black Belt, Ortho-Clinical Diagnostics, Salt Lake City, UT

ISO: The Great Umbrella

Over half a million ISO certificates have been issued around the globe, but only 30,000 of them have been issued within the United States , and very few of them in the Health Care System. Clearly, the rest of the world is more familiar with ISO, but it still needs a better introduction to the US, particularly in the healthcare arena.

Dr. Rabelo, (familiar to our regular visitors for providing essays on ISO), provided not only a description of the ISO concepts, but an example of the entire ISO certification process – from the initial decision to choose ISO to the final inspection and certification - at his laboratory, Fleury Diagnostics, in Sao Paulo , Brazil. The operational achievements by Fleury Diagnostics impressed many in the audience.

Dr. Rabelo provided a simple, useful description of ISO: ISO is an umbrella, a broad set of principles that encompass process tools like Six Sigma and Lean. It works as a set of Quality Management standards and creates a common language for management and the technical personnel.

Dr. Rabelo also pointed out that this is not the “old” ISO system, which was widely viewed as bureaucratic, obsessed with documentation, and focused only on quality assurance. The “new” ISO 9001: 2000 standard transformed a quality assurance focus into a quality management system (QMS).

Another way to describe ISO is that it is a generic QMS. That is, it starts by describing principles that are universal to industry and business. More defined ISO standards are also created for specific industries, but even then, general principles are described and implementation details are left to the user. Contrast this approach to CLIA: where the CLIA Final Rules tell you exactly how many controls to run, ISO would instead tell you to define a standard of quality first, and then meet that standard (you would define how many controls must be run to achieve that level of quality).

Dr. Rabelo described the core of the ISO 9001:2000, which consists of eight Management Principles:

Customer-focused organization As with many quality management systems, the customer is at the heart of ISO. ISO standards seek to understand the needs, both current and future, of the customer, and create the organization to fulfill those needs
Leadership Establish a unified purpose and direction for the organization. Given the breadth and scope of an ISO implementation, you will need a true management commitment to make it happen.
Involvement of people While ISO implementation may begin with the help of an external consultant, successfully implementing ISO - and sustaining the gains of an ISO certification - can only occur with the full involvement of employees. Dr. Rabelo pointed out that ISO need not be highly centralized – in fact, a decentralized approach can be more beneficial. When more people get involved with an ISO implementation, more of their hidden or underutilized knowledge and skills can be brought to bear on the challenges that face the organization.
Process approach ISO identifies processes, which are a set of interrelated or interacting activities that transform inputs into outputs. While simple in its definition, this approach enables the user to deploy several useful management and quality improvement tools. A critical part of ISO is to identify the processes in the business and improve them.
System approach On top of the process approach, ISO recognizes a system, which is a group of interrelated processes. The system as a whole can be guided toward an objective, resulting in efficiency.
Continual improvement ISO is not a one-time event. It is a system which places improvements and innovation as the permanent objectives of the organization.
Factual approach to decision making Decisions must be made on data. Collecting and analyzing the data is part of the ISO implementation process.
Mutually beneficial supplier relationships ISO recognizes the need for profit, and its standards are designed to enhance the ability of organizations to create value.

Conceptually, ISO implementation is really just a mapping of these concepts to the activities of the business, and evaluating whether or not the parts of the business is succeeding in meeting these principles.

On a more practical level, here's an oversimplification of the ISO implementation process:

1. Identify the ISO standard (or standards) that will be adopted, as well as the scope of its application.
2. Identify the resources (external consultants, internal staff, etc.) needed for ISO implementation.
3. Identify the processes and products to which ISO will be applied. This includes locating and managing all documents for the system, as well as identifying any non-conformities.
4. Train staff in ISO standards and its concepts , and explain how the System will work in the daily routine.
5. Define the quality indicators – the technical metrics that will be used to measure the success of ISO implementation. These include customer satisfaction, competencies, etc.
6. Train internal auditors – staff who will periodically conduct inspections and evaluations of processes.
7. Conduct internal audits
8. Find and fix any non-conformities.
9. Have the initial ISO inspection visit – although not an obligation for quality certification, it's the moment where inspectors will point out any problems prior the final audit . This is where an external inspector will come to the laboratory and evaluate your implementation.
10. Have the final ISO certification visit. At the end of this inspection, you should receive your ISO certification. But this is not the end. Internal and also external inspections continue after the certification.

For laboratories in the US, it is somewhat unlikely that they will seek ISO 9001:2000 certification right now, since it is not mandatory and it has a different approach when compared to the more specific, technically-oriented accreditation processes familiar to American labs. However, the ISO 15189 standard - although not an ISO certifying standard - is appealing, because it is more specific and addresses, albeit in broad terms, the particular goals that healthcare laboratories should achieve. ISO 15189 can be used as the basis for accreditation processes, which brings it closer to the US current reality. Several accreditation agencies around the world are using ISO 15189 as the basis for their accreditation process, including the new COLA QMS (Quality Management Systems) accreditation released this year. CAP may also include ISO 15189 in their accreditation program for the future.

Even with the accreditation programs in the USA moving toward being progressively based in ISO 15189, Dr. Rabelo contends that laboratories that are accredited with ISO 15189-based programs, will also gain significantly by going for ISO 9001:2000 certification, because this ISO standard is the big umbrela that will integrate all macro-processes and will add significant differentiation to those labs, and competitive advantage as well.

Six Sigma: Achieving Error-Free Production

The next speaker, Dr. Carl Garber, provided a useful concept about the relationship of ISO to Six Sigma. ISO is a mile wide but an inch deep (although, Dr. Rabelo replied, maybe a foot deep), while Six Sigma is a mile deep and an inch wide. Unique among the quality improvement tools, Dr. Garber said, Six Sigma provides the only way to achieve error-free processes.

Dr. Garber works for Quest Diagnostics, a company now well known for their enthusiastic adoption and implementation of Six Sigma.Quest has trained 1,300 green belts, 125 black belts, and 22 master black belts.

Six Sigma is well known to regular readers, so we won't discuss all of Dr. Garber's presentation (in particular, we will skip the introduction of the concepts). But there were some very interesting details on how Quest implements and applies Six Sigma to its processes.

Six Sigma is a very quantitative tool, but Quest has made it even more data-driven. For every project that they undertake, they construct a mathmatical equation that models the process. That way, in very simple terms, they can model the defect rate based on the inputs.

Dr. Garber explained that the typical goal of a project at Quest Diagnostics is to cut the number of defects in half. This is a more realistic goal than trying to achieve 6 Sigma for every process; a significant reduction of defects will have a real impact on costs, without requiring extraordinary effort. Dr. Garber also gave a rule of thumb on the effort required in Six Sigma projects:

  • To achieve 3 Sigma performance, usually only obvious changes and corrections are required.
  • To achieve 4 Sigma performance, processes must also be improved.
  • To achieve 5 Sigma, the design of the processes must be improved.
  • Finally, to achieve 6 Sigma performance requires rigorous tools and a design for perfection.

Talking about a subject dear to our heart, Dr. Garber noted that Quest Diagnostics uses the CLIA PT guidelines as a source for quality requirements. Based on those requirements, Quest makes its precision (CV) goal TEa/6, and its accuracy (bias) goal TEa/4.

The results for Quest Diagnostics have been impressive. Over 900 projects have been completed. Dr. Garber reported that for every dollar spent on Six Sigma efforts in 2003, Quest got a return of 3 dollars. In 2004, they increased their return on investement to 4 dollars for every dollar invested in Six Sigma.

Dr. Garber then gave some examples of Quest Diagnostics Six Sigma projects, which have mainly been focused on pre-analytical and post-analytical processes. They even applied Six Sigma to the problem of bad debts, reducing it from 7.0% in 2000 to just 4.5% in 2004 through Six Sigma techniques.

One project involved the reduction the waiting times at a testing center. After measuring the Sigma, they found the process was only 1.85 Sigma! Their project resulted improvements that reduced defects by 80%, raising the Sigma to 2.95. Still, this is a metric considered below par for industrial applications. So ultimately, the project included a new innovation: it allowed customers to make “reservations” and thus coordinate their arrival with the available staffing at the testing center.

In concluding, Dr. Garber asserted that no organizations could afford to ignore Six Sigma – it costs less to invest in Six Sigma than to ignore it.

Lean: Rapid, Radical Removal of Waste

Finally, Maureen Harte, possibly the first Master Black Belt trained in the clinical laboratory field, made an eye-opening presentation about Lean.

What is main thrust of Lean? It improves the speed of processes by reducing or eliminating waste. Lean integrates processes to make “definite products a definite way, within a definite time, at a profitable cost.” Ms. Harte said that laboratories, whose “products” are easily defined – test results – are a perfect place to implement Lean techniques.

Ms. Harte then defined the many different kinds of waste, with the basic definition that waste is anything that adds no value to the process (anything that a customer wouldn't be willing to pay for). Waste includes overproduction, inventory, transportation of product, rework, waiting, and underutilized knowledge. It also includes inspection – as others have noted long ago, and Ms. Harte reiterated, you can't inspect quality into a process – you really have to do it right the first time.

Eliminating waste is not exactly a novel proposition, and both ISO and Six Sigma target waste, but the way that Lean removes waste makes it possibly the most radical quality improvement management technique of the three.

First, at its very core, Lean insists on an approach that most laboratories currently do not embrace – individual processing (first in, first out, single piece flow). That is, when a test comes in, it is immediately run. As we all know, one of the fundamental concepts in clinical laboratories is batching. Ms. Harte pointed out, however, that batching causes many many different kinds of waste, among them waiting and transporting. Inherently, batches also make errors harder to see (one error is hard to notice in a large batch, and a large batch often gives the worker no time to deal with the problems within that batch). As laboratory instruments have gotten larger, the batches have grown larger, and so have the delays and waste.

Second, at least in OCD's case, the implementation of Lean is rapid, taking only approximately 3 months. While ISO certification can take years, and Six Sigma projects can take around 6 months, Lean aims for very rapid implementations.

Finally, there is an radical difference in a pre-Lean and a post-Lean laboratory. When OCD implements Lean in a laboratory, large inventories, drawers, and even chairs are eliminated from the workspace. OCD also requires that all staff receive extensive cross-training, since each worker will no longer be confined to a single type of testing – workers in a Lean lab do whatever work is necessary at that time, regardless of seniority or specialty. Often, Ms Harte noted, there is a real culture shock for the medical technologists.

So how does Lean identify waste? Through several techniques, including value stream mapping (VSM) and process mapping. These mapping tools help to understand the baseline state (how things work now), optimize the entire value stream (how things can work faster), and recognize that there is no end to the process (where improvements and innovation can be made in the future).

Another unique tool of Lean is the extensive videotape analysis of every second of the process and operators' actions. Lean consultants will typically record an entire process from start to finish, then subject it to second by second analysis to find ways to improve the process. Typically, carts, benches, and storage areas are reorganized for the easy “visual management” and the most efficient workflow (think ergonomics to an exponential power). Also the physical movement of the medical technologists is optimized so they make no excess motion. They will even track where a medical technologist walks in the lab during a testing process, and seek to reduce those steps to the bare minimum. After defining this future state map, the Lean consultants will define a “pulse” of the process, which defines how many tests or steps must be completed per minute of a shift.

One of the easy targets for Lean savings are inventory points. Any place in a process where “stuff is waiting” is an opportunity to reduce or eliminate the time and the drained on resources. Another example Ms. Harte gave was the fact that in some hospitals, up to 35-40% of the testing volume were pre-emptive “rainbow caps” - blood draws where every “top” is filled in the psychic expectation that the physician will decide to run additional tests.

The results in Lean projects are often dramatic reductions in TATs and soft dollar savings in staffing. There is also a sense that the laboratory is transformed into a true production environment, much like the Toyota production lines where Lean techniques were first formulated.

Can you handle this cocktail?

Probably the best thing to learn is that the three approaches are not mutually exclusive. If you're interested in Six Sigma, that doesn't prevent you from looking into Lean. If you're pursuing ISO certification, that doesn't mean you must avoid Six Sigma. All three approaches offer advantages, and they can complement each other.

Just how do these three approaches intersect? ISO provides the broad goals. Lean eliminates the gross waste in a value stream, and what process steps remain are the best targets for Six Sigma improvements. But before embracing all three quality techniques, think hard about whether your organization can handle it.

All three speakers noted that management commitment was required for success. However, for any organization embarking on multiple quality initiatives, management must be very committed. Embracing ISO, Lean, and Six Sigma will require extensive training, major changes in culture, not to mention a mouthful of buzzwords.

Even trying to implement just one of these programs requires more than tepid enthusiasm. And attempting to graft ISO or Lean of Six Sigma on top of current management practices is only a recipe for failure. None of these are “add on” programs – half-hearted or part-time implementations will produce only limited, temporary gains, at best. To enjoy enduring success, the organization must be willing modify its core DNA. So if your chief officers aren't willing to stake their careers (and their salaries) on the success of the program, then ISO/Lean/Six Sigma will be the equivalent of a one night stand: brief, exciting, but ultimately disappointing.

Are there really companies out there doing all three? Yes. But they are few and far between at this stage. We at Westgard QC know of companies that are implementing ISO, Lean, and Six Sigma, but most are still in the early stages of training, so it's too soon to report on their progress.

Stay tuned.