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
Westgard QC is proud to announce 2 new public workshops to be held this year:
Both workshops will be held at the DoubleTree Hotel in Madison, Wisconsin.
For more than a decade, the Westgard Workshops have provided in-depth training that can't be found at other conferences. If you want to be more than an anonymous seat in a cavernous hall... If you want to learn whether or not the latest management fad has any real applications in laboratories... If you want honest assessments instead of equivocal statements... If you care more about practical tools than precious theory... You need to attend the Westgard Workshops.
More details on the workshops after the jump...
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Posted by Sten Westgard, MS
Earlier, we posted an article on the website with a darkly humorous take on the passing of the CLSI EP22 guideline, which voted itself out of existence in late 2010. Other websites have also noted its passing.
But it's worthwhile to take a moment to discuss, in all seriousness, where we are with Risk Information, Risk Management, "Equivalent QC", and the CLIA Final Rules. How did we get here? What drove us to this state? Where are we going next?
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Posted by Sten Westgard, MS
The National Oil Spill Commission released a preliminary chapter of its report today. This is the commission charged with finding out what went wrong with the Deepwater Horizon / Macondo oil rig in the Gulf of Mexico that blew up in 2010 and spilled 4 million barrels of oil and killed 11 workers.
Whenever there are big stories in the media, we like to take a look at them to see if we can learn anything, find any connection between the disaster and our own situation in the medical laboratory community. But from a distance, it's hard to see any similarities between oil rigs and labs, right?
Right?
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Alan Greenspan gave some instantly notorious testimony to the US Congress recently:
“I was right 70 percent of the time, but I was wrong 30 percent of the time,”
I'm not sure what was more concerning; the fact that he admitted that almost a third of the time he was wrong, or that he clearly believes that being right only 70% of the time was acceptable. Clearly, for a man once called "The Oracle" and Maestro, he was lowering the bar on the standards for judging him.
Testimony like that raises some instant questions:
- If Alan Greenspan was responsible for setting the direction of the world's greatest economy, is a 30% error rate acceptable?
- If Alan Greenspan was an airline, would you fly him?
- If Alan Greenspan was a core laboratory test, would you buy the instrument?
- If Alan Greenspan was a glucose meter, would you buy the device?
Posted by Sten Westgard, MS
In the January editorial of Clinical Chemistry, Few Point-of-Care Hemoglobin A1c Assay Methods Meet Clinical Needs, by David E. Bruns1 and James C. Boyd, there’s a key paragraph that goes beyond the HbA1c methods covered by the study by Lenters-Westra and Slingerland (Six out of eight hemoglobin A1c point-of care instruments do not meet the generally accepted analytical performance criteria. Clin Chem 2010;56:44 –52.)
“There is increasing recognition of a need to improve the precision of HbA1c assays, in view of the low biological variability of Hb A1c. The NGSP plans to reduce the
acceptability specification for level 1 laboratories to 0.70% and for manufacturers of all Hb A1c methods to <0.75% in 2010 (http://www.ngsp.org/ ngsp/prog/News/manuf09.html; accessed October 28, 2009). The College of American Pathologists (CAP) also has recognized the need to tighten total error criteria for Hb A1c and is in the process of
revising the criteria used in grading proficiency tests (http://www.
ngsp.org/ngsp/prog/News/manuf09.html; accessed October 28, 2009). In 2007,
the limit specified by the CAP for acceptability on HbA1c proficiency testing was +/- 15% of the target value. This limit was lowered to +/-12% in 2008 and to +/-10% in 2009, and it will be lowered to +/-8% in 2010 and to +/-6% in 2011. “
As these quality requirements tighten, how are we going to respond?
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Posted by Sten Westgard, MS
By Sten Westgard, MS
Posted by Sten Westgard
While Dr. Westgard has given a thorough update on the status of EP22 and EP23, as presented at the AACC/ASCLS conference in Washington, DC, and Dr. Jan Krouwer has done the same on his own blog, I thought it worth beating the dead horse on this.
Dr. Jan Krouwer was there at the presentation and asked perhaps the most important question about EP22 since it was created. Is the FDA going to review the Risk information created by manufacturers about their instruments?
I think the answer was somewhat nuanced and subject to interpretation. According to Dr. Krouwer, he heard that the FDA would review EP22 Risk information, but only superficially, and "only egregious problems would be flagged by the FDA."
Basically, I heard the same thing, with a slightly different interpretation: the FDA isn't really going to review the Risk information when the device is first submitted to them. But retrospectively, it might review them very thoroughly. Since the FDA has authority over labeling and branding of medical devices, if it turns out that some of the risk information from a manufacturer is incorrect, inaccurate, or misleading, than the FDA retains the power to sanction the manufacturer.
In other words, manufacturers have the right to remain silent (i.e. don't produce any Risk information, since EP22 is voluntary), and anything they say (i.e. the EP22 Risk information) can be used against them in a court of law.
Call it the Manufacturer's Miranda Risk Rights.
In the absence of a legal mandate, I don't see why any manufacturer would willingly create this Risk information and distribute it to their customers. Any corporate lawyer will be advising against it (liability exposure). Any marketer will argue against it (if our competitors aren't saying they have residual risks, why do we need to do so?). Any executive will oppose it (why are we exposing our weaknesses to our competitors and our customers?). And that's the just the internal opposition this will face.
Certainly, I believe disclosure of Risk is the right thing to do, but the competitive and legal environment are not going to be receptive to it. Unless customers overwhelmingly demand this information, manufacturers will have no incentive - and many disincentives - to produce Risk information.
As Dr. Krouwer laments, there is a lot of good work in the EP22 and EP23 guidelines, but because of the toxic environment, these standards are likely to be stillborn.
Yet another sorry milepost in the story of EQC, AQC and Option 4. -----
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. -----
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.
by Sten Westgard, MS
Updated 11/7/08