Westgard Workshops 2006, Part II: What was unsaid

originally posted June 13, 2006

The first day of the Westgard Workshops covered Standards and Practices, Indicators and Guidelines.

We were lucky enough to have presentations by both CAP and JCAHO officials, detailing the latest changes in the checklists, guidelines, patient safety goals, etc. I can't do justice to all the details here. There are simply too many changes year to year to cover in a short note. What's frightening is that ever since the "final" CLIA rule in 2003, every year is bringing a huge set of changes. You would think that a laboratory would need to have a FTE devoted just to tracking the changes in the regulations.

Obviously, unannounced inspections were a hot topic. But even more interesting was what wasn't being said.

With the CLSI committees working on several new guidelines for both manufacturers and laboratories (EP22 and EP23), with CLIA still formulating what "Option 4" is going to be, this year is mainly about anticipation. Cross your fingers, because we are really hoping that the people who gave us the disastrous EQC options 1 through 3 and going to hit a home run this time.

An even more intriguing silence was the  impending GAO report. As you recall, in the wake of the Maryland General Hospital problems, several congressmen asked the GAO to evaluate how CMS, CAP and JCAHO were doing their jobs. This has been a multi-year evaluation.

Well evidently, the GAO has finished the report and it was supposed to be released to the public in early June. Our JCAHO presenter, Kathy Steffens mentioned that a draft report had been delivered in April. CAP has already responded. JCAHO has also responded. But CMS asked for an extended period of time to respond.

Overall, there is an expectation that this GAO report is going to be a disappointment. It will ask for changes, but many of those changes will not be useful. It may reach some strange conclusions. And the odds that analytical quality is going to be improved by this report are very slim.