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?
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
By Sten Westgard
On November 4th, the Joint Commission issued an interesting press release, titled "Lab Decisions Will No Longer Affect Hospital Decisions."
The specific language of the press release stated:
"Beginning January 1, 2009, under new Joint Commission policy, laboratory accreditation decisions will no longer immediately impact hospital accreditation decisions."
I have subsequently seen comments on a listserve wondering if it's now acceptable for JC-accredited hospitals to have laboratories that fail inspections. The simplistic interpretation of this rule is that laboratory problems no longer impact the hospital. Hospitals can keep running regardless of the state of their laboratory.
But that's not really the case.
I contacted Megan Sawchuk, Associate Director of the Standards Interpretation of the Joint Commission. She elaborated on the new policy and cleared up any ambiguity:
"The December 2008 Perspectives announcement regarding laboratory accreditation decisions has two important elements. One, the Accreditation Committee voted to eliminate the automatic, direct weight of an adverse decision in the laboratory on the hospital. And two, an adverse laboratory decision from The Joint Commission, CAP or COLA will be added to the hospital's Priority Focus Process (PFP) data. PFP data is presently used by The Joint Commission to monitor the hospital's overall performance and prioritize the timing of their unannounced survey in the 18-39 month window. Thus, an adverse decision in the laboratory will significantly increase the likelihood of an earlier hospital survey to assess compliance at the organizational level.
"By using this method, the hospital decision is based on their actual overall performance with consideration of that of the laboratory. This is an improvement over the current process of automatically applying an adverse laboratory decision to the hospital, which assumes an overly simple relationship between the two integrated but separate entities. Noncompliance in the laboratory is often associated with poor performance in the overall organization, but not always. This method also maintains the integrity of the the laboratory as an essential service in the hospital's accreditation decision process."
To be clear: a failing laboratory will still take down a hospital with it. The downward spiral to revocation of accreditation may not be as fast as it used to be. But the usual regulatory process takes time in any case. Inspections generates citations, which require responses, which may then generate additional inspections, additional responses, etc. Immediate action happens very rarely. The Joint Commission retains all the policies and tools they need to come down hard on a lab and hospital. This new policy just gives them a little more latitude.
One last thing: this is a clear admission that many laboratories in America have significant problems. If laboratories were operating perfectly (or even just in compliance) and there weren't any worries about them, we would have no need to decouple their accreditation decisions from the hospitals.
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New Download: Sigma-Metrics Tool (and audioconference presentation)
On September 4th, 2008, Dr. Westgard spoke as part of the AACC audioconference on "New Directions in Laboratory QC" - which was subsequently quoted in the Clin Lab News article on Risk and CLIA. We are pleased to make available Dr. Westgard's complete presentation, as well as two Sigma-metrics Charts and instructions on how to use them in QC Design.
Westgard Sigma Analysis: A new direct HbA1c Method
At the 2008 AACC/ASCLS convention, a poster was presented for a new direct enzymatic assay for %HbA1c. How does it stack up against HPLC and immunoassay methods? How do you judge a method when you've got multiple comparison methods and multiple quality requirements?
Interview: Dr. R. Neill Carey (A brief introduction to EP 15)
We were fortunate to get R. Neill Carey, PhD, the chair of the CLSI EP 15 committee, to present and
explain that new standard at the Chicago Method Validation workshop. He also contributed a chapter to the new Basic Method Validation manual on the same topic. But for those who have never heard of EP 15 before, we conducted a short interview with Dr. Carey. This short introduction to EP 15 may pique your interest in this new guideline.
Thinking about Three Sigma: 2 thoughts on troublesome performance
In a previous lesson, we discussed some possible actions to take when the Sigma-metric for a method is higher than Six. But what about those methods with low Sigma-metrics? What do you do when Sigma analysis delivers bad news?
by Sten Westgard, MS
Updated 11/7/08
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.
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
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. -----
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