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. -----

By Sten Westgard, MS

While Dr. Westgard has spoken about the "War of Words" between Uncertainty and Total Error in several essays (here, here and here most recently), we thought readers might want an additional perspective on the issue.

Dietmar Stockl, an expert in statistics and laboratory quality control from across the Atlantic, graces us with an guest essay on the calculation, use, benefits and limitations of measurement uncertainty: Time to Engage in Measurement Uncertainty. Dr. Stockl provides an in-depth look at uncertainty concepts and calculations, as well as a moderate viewpoint on the use of the term. He views both Total Error and Measurement Uncertainty are useful concepts and believes there is room in the world for both of them. It's not necessary for one term to eliminate the other.

Not so coincidentally, a colleague of Dr. Stockl's, Linda Thienpont, has a letter in Clinical Chemistry talking about the attempt to incorporate bias into the calculation of measurement uncertainty. If bias can be thrown into the uncertainty calculations, a case could be made that Total Error is no longer necessary. Dr. Thienpont points out that slipping bias into the uncertainty calculations is not a good idea and can lead to distorted results. She concludes that bias must remain separate from uncertainty calculations, which means another approach like Total Error is required to account for it.

See more at Thienpont LM. Calculation of measurement uncertainty-Why bias should be treated separately. Clin Chem 2008;54:1587 (subscription required) -----

One last report on the AACC/ASCLS conference.

What do you get when you combine techno music, pulsing neon light, flashing LED badges, Lance Armstrong-style rubber wristbands, a free buffet, and five open bars?

Labs Are Vital. The Abbott launch of a truly important initiative.

Jeffrey R. Binder, President of Abbott Diagnostics and Senior Vice President of Operations for Abbott, announced a new program to address the biggest problem facing the healthcare laboratory: the coming shortage of qualified laboratory workers.

In the last 25 years, more than 600 schools and university programs for medical technology have closed. In 2012 we will need 138,000 laboratory scientists, but at best there will be 42,000 available. (source) Why? Low salaries for workers mean less interest in the profession. Worse still, the schools and programs face high expenses. Providing instruments and other devices necessary to properly train technologists is not cheap.

Here's where Labs are Vital comes in. At this event, Abbott announced a new $1 million dollar donation program - schools and programs can apply for free instruments, reagents, and service. AACC past president, Stephen Kahn, PhD and Bernie Bekken, President of ASCLS, were present to welcome this new effort.

It's good to see that Abbott recognizes a critical reality: While Abbott may be comfortably profitable, their future profits are in jeopardy if there aren't enough workers to run their instruments. Not only do the schools need to be supported, but the profession itself needs to be supported. Labs and lab workers need some better public relations - and they need to get out of the basement. In the increasingly cost-stressed healthcare system, the anonymous role of the laboratory worker means out of sight, out of compensation. Labs Are Vital hopes to raise the profile of the laboratory worker and make more of them.

Abbott noted that the Labs are Vital program would be non-branded and invited participation by other diagnostic companies. This part is key. For any real initiative to succeed, it can't simply be a marketing effort by a single company. It's an easy PR move for a company to make a donation. But if the initiative is strongly identified with just one company, there is less incentive for other companies to participate.

How will the other companies react? Will they join the effort? Will they create their own? We'll see.

-----

I’ve been intrigued by some of the reasoning that is guiding laboratory priorities and directions, particularly the emphasis on pre-analytic and post-analytic processes along with a disregard for the quality of analytic processes. You can see this emphasis in the IQLM recommendations for laboratory quality indicators.

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

Abbott Diagnostics is sponsoring a series of Webinars about Quality Control, conveniently scheduled for the Asian market

Register for these webinars at https://www.labexcellence.in  [see the webinar descriptions after the jump]

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

We got the following question emailed to the website recently:

Greetings, I was [wondering] if the following case represents [violation] of 4 1s rule?

Control (A) point 1= EXCEEDS 2 SD /-2 SD lines >> warning

Control (A) point 2= WITHIN 2 SD/-2 SD lines >> accepted

Control (A) point 3= EXCEEDS 2 SD /-2 SD lines >> warning

Control (A) point 4= WITHIN 2 SD/-2 SD lines >> rejection

all the point[s] on the same side of the mean.

What do you think? The answer, after the jump

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

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

The news hasn't been getting any better over at Theranos. Since the Wall Street Journal pierced the facade on Theranos' promise of revolutionizing the lab test industry, there have been additional stories that Walgreens is seeking an exit from their partnership, that some of their premier clinical partners, Intermountain Healthcare and Cleveland Clinic, have not even started  work on any validation studies with Theranos technologies, and that Capital BlueCross has put a stop to Theranos blood-drawing at the insurer's retail store in Pennsylvania.

But that's nothing compared the release of the full, but redacted, CMS inspection report of Theranos' Newark, California laboratory.

Earlier, we had seen the top sheet of the report, noting five major violations that meant Theranos was putting its patients in "immediate jeopardy."

The full report, more than 121 pages long, is as bad an inspection report as I have ever seen. More explanation of this, 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...