By Sten Westgard, MSWe 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:
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
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.
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.
-----
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 NIAHOSM (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.
-----
Posted by Sten Westgard
Back at the 2008 AACC conference in Washington, DC, Dr. Westgard sat down for an hour with some friends from COLA. They interviewed him on a number of topics, from his personal story and the journey of his career in laboratory medicine, to the origin and use of the "Westgard Rules."