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There are many changes in store for the laboratory in 2012. Are they good changes? risky changes? Will these changes get us closer to our ultimate goals? The two Westgards look ahead.

New Year, New Goals, New Risks

January 2012

JAMES O. WESTGARD,. PHD
STEN A WESTGARD, MS

This is the time of year when most people have made their “new year’s resolutions” to quit smoking, lose weight, eat better, exercise and adopt many better behaviors. The New York Times notes that the main beneficiaries of these aspirations are health clubs, weight loss programs, nicotine patch makers, etc.. Despite good intentions, most people don’t fulfill their resolutions. After a short time, the resolve fades, the diet ends, the gym membership goes unused. And then we make the same resolution again next year…

2012 is going to be a big year of change for healthcare. In the US, many of the provisions of the Affordable Care Act are starting to kick in. For example, hospitals and labs may become Accountable Care Organizations (ACOs) this year. But even as new changes by the healthcare law come into effect, the very premise of the law (the constitutionality of an individual mandate to purchase health insurance) is going to be decided by the US Supreme Court in March. If the law is struck down, either in part or in full, what happens next is anyone's guess.

In this atmosphere, it’s no wonder that many laboratories are adopting a wait-and-see approach. Anxiety often drives us to paralysis. As residents of two states (WI, CT) with large populations of Odocoileus virginianus, let us give you some advice: the “deer in the headlights” strategy does not produce good outcomes. It’s much better to keep moving toward a goal.

More than just another year of change, 2012 is going to be a test of resolve for the laboratory. It feels like every year has been a year of change for labs. But this year, our regulators promise, is the one where our rules are going to get better. We’re going to improve quality and make it easier on the laboratory to comply.

New Risks

2012 brings with it the impending adoption of Risk Analysis and Risk-driven QC Plans into the US regulatory framework. A new QC guideline - EP23A - was published late last year by CLSI, and there has been an aggressive schedule of webinars to educate the public about this.

We’ve been waiting for these alternative QC protocols for decades. When CLIA was first published back in 1988 and the implementation rules published in 1992, there was a provision for manufacturer’s QC clearance, which was postponed and postponed and postponed, then finally dropped and deleted. Then, in 2003, when the Final Rule was finally published, a new concept – equivalent quality testing – emerged from the regulations. But then we had to wait another year before that concept was made clear. It took on definition in the “Equivalent” QC Procedures that were mentioned in the Interpretive Guidelines found in the State Operation Manual. Unfortunately, this new approach – and the validation protocols that were invented to accompany them - was NOT scientifically sound. Despite years of effort, neither CMS nor numerous committees of CLSI could create a scientific foundation that would justify the validation protocols or the concept of EQC. Once it became clear that CMS “blew it”, the search was on for a new approach, another technique that might allow laboratories to take a different path on QC.

Now that EP23A has been published, and CMS has stated it will adopt EP23 as the accepted approach for an alternative QC assessment, the details still remain unknown. Until the next update to the Interpretive Guidelines in the State Operator’s Manual (SOM) is published, we don’t know exactly what laboratories will have to do to demonstrate the proper use of Risk Analysis to develop their QC Plans. Even more unclear is how inspectors will enforce and evaluate laboratories that have used Risk Analysis to develop a QC Plan. How will “deemed” accreditation organizations like The Joint Commission, CAP, COLA, and others, integrate the new Risk Analysis approach into their current guidelines, checklists and methodologies? Again, we don’t know the details yet. It will probably take at least a year to find out. Whatever the new CMS rules will be, they will be “educational” – that is, not enforced – for at least the next two years.

The challenge for the regulators, the accreditation agencies, and the laboratories is whether these new Risk-driven QC Plans will improve quality, or compromise quality but make it easier to be in compliance? Here’s where each group must show its resolve. It’s easy to create a set of requirements that can be followed, if the goal is only compliance. If the goal is actually to improve quality, the job is harder. The government might be tempted to make ambiguous regulations, so they have a lot of “wiggle room” when it comes to enforcement. Accreditation organizations might be tempted to keep their regulations loose and easy, so as to make their services more attractive to potential customers. Laboratories might be tempted to choose the easiest, cheapest accreditors, so they can reduce their operating costs to the barest minimums. It takes resolve to do more than comply. If your goal is excellence and better patient care, it takes resolve to sustain that goal.

New Goals

2012 also brings the latest update for the biological variation database, a project now in its seventh edition. Since 1999, Dr. Carmen Ricos and her colleagues in Spain have been surveying the literature and evaluating the data on within-subject biologic variation for various analytes. The latest update contains more than 45 new analytes and even more entries for different sample types. The database now covers 369 analytes, more than any other source of quality requirements in the world. We are truly grateful that Dr. Ricos and her colleagues continue to make this important resource available to the world. We are proud to be able to offer it on the website.

The challenge with the new goals is that these quality requirements are not driven by compromise or compliance, but by the demands of the body itself. In many cases, the requirements derived from biologic variation are far tougher than requirements generated by regulators or proficiency testing/external quality assurance groups. For some analytes, the quality truly required by the test (based on biologic variation) is a goal that no current method on the marketplace can reach. Take HbA1c, for example, where the goal from CAP is now 7% - after successive years of tightening down from 15%. The desirable specification for allowable error from biologic variation is just 3%! To achieve world class performance based on that goal would require most methods to aim for imprecision less than 0.5%. We have some very good HbA1c methods on the market right now, but we are probably a few years away from having that level of precision. So what’s a laboratory to do?

Fifteen years ago, there weren’t many sources of quality requirements. Today, Laboratories can access CLIA requirements, look up the biologic variation database, perhaps look at Australasian RCPA QAP goals or German Rilibak goals, and more. It’s become much easier to find a quality requirement – now the real question is, which one is appropriate for your laboratory? Which quality requirement reflects the demands for quality of the patient population your laboratory serves? If you can choose that quality requirement, can your laboratory take the steps necessary to assure that level of quality is actually being achieved? Again, it’s a challenge to your resolve. A laboratory interested in only the lowest level of compliance and quality may never attempt to define the quality required by their tests – it’s easier to remain arbitrary and hope that the quality is being achieved rather than measure it. But the labs that make the extra effort get not only the knowledge that they’re providing better quality for their patients, they can leverage that quality into better information provided to clinicians (through RCVs, optimized QC, and other metrics).

New Resolutions: What's Yours?

As for Westgard QC, it’s our resolution to provide you with even more guidance, help, and tools. As the new Risk regulations unfold, we’ll analyze them and let you know how to evaluate and implement the new requirements.

We hope our resolultions help you stick to your resolutions.

Happy New Year!