The Westgard Rules

DNV Healthcare and Labs - a correction

By Sten Westgard, MS

In an earlier post about DNV Healthcare and Laboratory accreditation, I inadvertently implied that only CAP or COLA accreditation would be accepted by DNV. I should have been more precise in my listing of possible accreditation agencies for laboratories; that was a mistake on my part. I didn't intend to imply that only those two accreditations would be accepted by DNV. My apologies for my imprecise statement.

The important point is that DNV currently will not accredit labs. If you move to DNV Healthcare to accredit your hospital, you will need to have another agency accredit your laboratory.

Again, I am sorry to have given the wrong impression. Thanks to Margaret Peck of Joint Commission for alerting me to the problem. The original post has been corrected as well.

Sten

Thank you, Rochester

By Sten Westgard, MS

We got a big dose of "Minnesota Nice" during our workshop in Rochester, Minnesota. The participants were very helpful - some of them showed up earlier than we did and helped set up the table arrangements for the room! There really is a different culture in the midwest, a spirit of kindness and cooperation that you don't always find in states that lack prolonged sub-zero winters.

When you think of Rochester, Minnesota, your first thought might be the Mayo Clinic. While we were very happy to have many Mayo Clinic attendees, the workshop was actually hosted by the Olmsted Clinic. That's the other hospital in Rochester:

There's a pretty good reason why we picked Olmsted as the host. Take a look at the picture below, where the Medical Director of Olmsted is posing with us:

I realize the picture is small, but I'm guessing you can see a family resemblance. That's right, the Medical Director of Olmsted Clinic is Dr. David Westgard, the brother of Dr. James Westgard. So the day was filled with an excess of Westgards. Dr. David Westgard introduced Dr. James Westgard, and Sten Westgard also presented a few of the topics. In addition to an education on method validation, the audience got an introduction to the Westgard family dynamics. Statistics and North Dakota jokes actually work well together

Thanks again to Olmsted for hosting this workshop and providing us with an excellent opportunity for a mini-family reunion.

Thank you, Chicago

Posted by Sten Westgard, MS

Pictured here left to right:
Frank Quinn, PhD; James O. Westgard, PhD; R. Neill Carey, PhD;
and Sten Westgard, MS

October 10th was a great day to talk about statistics, particularly since our numbers were doing better than the numbers on Wall Street.

We were blessed by the last minute addition of R. Neill Carey, PhD, who provided an excellent discussion of EP15, the new (at least to most labs) method validation protocol from CLSI. EP15 is sort of a mini-validation protocol all by itself, providing abbreviated studies for imprecision and bias. It also is one of the first CLSI standards characterized by real ISO influence; the terms used in EP15 are really based on the ISO terminology (for instance, EP15 actually talks about "trueness" instead of bias; "repeatability" instead of within-run precision). What better way to learn about this standard than to hear from the chair of the committee that created it? Neill explained this new standard in a way that few others could.

Thanks also to our Chicago workshop participants, who provided some challenging questions and good discussion. Last but not least, thanks to Abbott Diagnostics for hosting this training event. We had a good group of people in Chicago and Abbott rolled out the red carpet for them. Dr. Frank Quinn, Director of Global Scientific Affairs of Abbott Diagnostics provided the introduction to the workshop. Special thanks also to Dr. David Armbruster, also of Abbott Diagnostics, who made this event possible.

Now, off to Rochester, Minnesota for the October 17th version of this workshop...

CLIA at 20

posted by Sten Westgard, MS

This week, AACC is going to host an audioconference on the latest update of CLIA. We're celebrating 20 years of CLIA in 2008.

Over at the online store, you can celebrate by saving $20 off the price of the CLIA Final Rules manual.
Use the coupon code clia20 during the checkout and you'll save $20.

This offer will run from now (October 6th) until Halloween - that's more than 20 days of savings.

DNV Healthcare - Hospitals now, Labs later?

After some follow-up, we need to note that DNV Healthcare has only been deemed by CMS for accrediting hospitals. They did not get deemed status for laboratory accreditation.

In other words, they cannot inspect or accredit laboratories. Any hospital that switches to DNV Healthcare will need still need to to accredit their lab by some other agency. [In an earlier version of this post, I inadvertently implied that only CAP or COLA accreditation would be accepted by DNV. That was a mistake on my part. I didn't intend to imply that only those two accreditations would be accepted by DNV. My apologies for my imprecise statement. The important point is that DNV currently will not accredit labs. ]

Whether deemed status for laboratory accreditation is in the future for DNV Healthcare is anyone's guess. It took years of battling for DNV to achieve the hospital deeming authority. Getting to laboratory deeming authority may require years more.

Still, this reality may make it less attractive for JC accredited hospitals to switch. If you currently use JC for both your laboratory and hospital accreditation, switching to DNV will require you to switch to COLA or CAP as well. Two switches for the price of one?

CAP may be a better fit with DNV's hospital accreditation, since CAP offers an ISO 15189 approach and DNV is going to stress ISO 9001 as part of the accreditation. But COLA has also been using a lot of ISO terminology and quality systems approach in their accreditation.

c8000 Sigma Analysis

Posted by Sten Westgard

One of the highlights for me of the AACC convention in Washington, DC, was my inclusion in a poster that analyzed the method performance of the Abbott Architect c8000. I'm pictured here with fellow authors (left to right) Gene Osikowicz, Charles Wilson, and John Baker (lead author). They deserve most of the credit for the work of collecting the data.

The poster can be viewed here and the QC application on Westgard Web can be viewed here.

The New Kid on the Block

Sten Westgard, MS

The game of accreditation agencies hasn't changed much over the last 40 years: Joint Commission, CAP, COLA. Laboratories didn't have many other choices.

Now there's a new kid on the block.

CMS recently approved DNV Healthcare as a new hospital accreditation organization. DNV's hospital accreditation program has met all the CMS requirements to deem hospitals in compliance with the Medicare Conditions of Participation. The DNV program is called NIAHO^SM (National Integrated Accreditation for Healthcare Organizations). [ DNV stands for Det Norske Veritas which is a Norwegian-based company that provides accreditation, certification, risk management and other services to many industries. What is it about Scandinavians, quality, and regulations?]

What's more interesting than just the entry of a new player into the accreditation market is their approach. NIAHO is not another compliance-oriented program - participation in this accreditation program requires the hospital to seek and achieve ISO 9001 certification. So hospitals will have to be accredited by NIAHO and certified in ISO 9001.

Here's the schedule DNV proposes for accreditation and certification:

• Year One: NIAHO Accreditation Survey and ISO 9001 Pre-assessment Survey
• Year Two: NIAHO Accreditation Survey and ISO 9001 compliance or Certification Survey
• Year Three: NIAHO Accreditation Survey and ISO 9001 Periodic Survey
• Year Four: NIAHO Accreditation Survey and ISO 9001 Periodic Survey
• Year Five: NIAHO Accreditation Survey and ISO 9001 compliance or Re-Certification Survey
• Year 6 through Year 8 and Beyond: Continue to repeat Year 3 through Year 5.

DNV will conduct annual unannounced surveys on hospitals. That's a significant change right there.

DNV's NIAHO is different than CAP's nascent ISO 15189 program. CAP is offering an ISO certification on top of the usual certification. That is, you have to do the usual CLIA-based certification, but you can add ISO 15189 on top of it. If you choose DNV Healthcare, you'll have to seek ISO 9001 certification as part of the process. Compliance alone is not a DNV option.

We have yet to see what kind of specific laboratory rules DNV Healthcare will provide. As with a lot of the ISO standards, specifics are often hard to find. Many ISO standards provide broad goals without technical specifics, leaving it up to the managers to adapt and apply the rules. Will there be Checklists? Tracers? Something else? So far, we don't know.

Obviously, whatever DNV Healthcare applies will have to be in compliance with CLIA regulations. But how will ISO 9001 and CLIA minimums mix? Will DNV require more from hospitals and laboratories than JC or CAP?

The even bigger question is - will DNV Healthcare compete on cost, quality or another feature? The cynic in us wonders if more competition will drive down prices and possibly sacrifice quality. The optimist in us thinks it would be interesting to see an accreditation body make excellence, instead of compliance, its competitive strategy.

Stay tuned.