Posted by Sten Westgard, MS and James O. Westgard, PhD

As reported elsewhere on the website, several of the symposiums this year were on standardization and harmonization for various analytes. This year, however, there was an added note of urgency. For many laboratorians, standardization seems like a somewhat esoteric subject, important but not necessarily pressing. But with the expectation of widespread implementation of electronic medical records, the problems with “comparability” of test results (and analytical methods) are about to become stark.

Posted by Sten Westgard, MS

I have been meaning to post this for some time. Our good friend and colleagues, Dietmar

Stöckl and Linda Thienpont, started their own website in the latter part of 2008: STT-Consulting

By 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.

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. -----

Originally posted April 21st, 2006

To:
    Those who will influence the future quality of laboratory testing
CLSI Area Committee on Evaluation Protocols
CLSI Subcommittee on Establishment of Manufacturer’s QC Recommendations
CLSI Subcommitee on Laboratory Quality Control Procedures

I want to call your attention to an article on “The Quality of Laboratory Testing Today” that was published in the American Journal of Clinical Pathology in March 2006 (v125:pp343-354). This article was prepared for the “QC for the Future” workshop, which was held in March 2005 in Baltimore. Because you attended this conference and/or are involved in the ongoing project work to develop QC for the Future, I hope you will have some interest in the results of this study.

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Recently, a user submitted a question about the mandatory use of the 10_x rule on chemistry analytes as mandated by ISO 15189 through NABL:

"Specific criteria of accreditation of NABL India (for ISO 15189) say that 10x should be considered as a violation for clinical chemistry  and Immunoassay parameters. However we understand that Westgard rules consider it as a warning only. Please advise."

So, the central question is, does ISO 15189 mandate the use of the 10_x control rule?

Posted by James O. Westgard, PhD

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

My esteemed colleague, good friend, and keen-eyed tracker of all things regulatory. Dr. Sharon Ehrmeyer, alerted me to a HUGE change in US regulations.

In April CMS sent out a memo title "Policy Clarification on Acceptable Control Materials Used when Quality Control (QC) is Performed in Laboratories"

This memo may contain as big a shift in regulatory policy as IQCP was to EQC.  More, after the jump...

Posted by Sten Westgard, MS

With sincere thanks to Carolyn Maurer, the Director of the CAP 15189 program.

As the new IQCP regulations kick in, it's been interesting to see the international reaction to them.

I admit that I thought the IQCP impact would be contained within the US, that contagion would not spread to the international community. After all, IQCP is only a required option for labs within the US, and then only required for labs that seek to find a replacement to their now-outdated EQC policies. For labs that don't want to reduce their QC frequency below once a day, there's no need to create an IQCP at all.

But the situation appears to be more complicated. CAP, which has a significant international presence, is rolling out IQCP to all of its members, not just its US customers.

In light of that, I asked CAP how it balances the IQCP reduced QC frequency with the ISO 15189 standards. Their answers, after the jump...

Posted by Sten Westgard, MS

A recent op-ed in the New York Times by Dr. Robert Wachter as well as an interview with Don Berwick in HealthLeaders Media broached a taboo topic: is healthcare measuring too much?

'[T]he measurement fad has spun out of control. There are so many different hospital ratings that more than 1,600 medical centers can now lay claim to being included on a “top 100,” “honor roll,” grade “A” or “best” hospitals list. Burnout rates for doctors top 50 percent, far higher than other professions. A 2013 study found that the electronic health record was a dominant culprit. Another 2013 study found that emergency room doctors clicked a mouse 4,000 times during a 10-hour shift. The computer systems have become the dark force behind quality measures.'
How Measurement Fails Doctors and Teachers, New York Times, January 16, 2016

As the global debate over establishing the best error models and performance specifications rages, laboratories are probably asking themselves the same questions that the doctors are asking: how many metrics are too much?

A possible answer, or at least some more questions, after the jump...

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

While traveling in the middle east recently, I was asked by a colleague about the new US IQCP regulations, specifically how to implement them in their foreign laboratory.

Frankly, I was a bit shocked. I didn't realize that anyone outside the US was paying attention to the IQCP roll-out.

But it does raise a good question: Is IQCP a global necessity? Or merely a US idiosyncrasy?

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

During my travels, I came across this at a laboratory which shall remain anonymous, where they are required by ISO 15189 to report measurement uncertainty to their clinicians:

If you can't read that interpretive comment, I'll spell it out after the jump...

Posted by Sten Westgard, MS