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
Posted by Sten Westgard, MS
In June of this year, Zoe Brooks presented an AACC-sponsored webinar with the title, Laboratory QC: Bridging the Gap Between Theory and Practice. During this webinar, Zoe presented a poll and more than 100 participants responded. The results are very interesting...
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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.
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Posted by Sten Westgard, MS
A recent abstract from the 2009 IFCC/EFCC (Euromedlab) caught my eye:
Quality Indicators for Laboratory Process; assessment in the Trento Department of Laboratory Medicine.
I Caola, C Pellegrini, N Bergamo, E Saurini, P Caciagli.
CCLM 2009
Examining the quality records of five laboratories, they applied a set of Quality Indicators from the IFCC. Errors were tracked and tabulated. The results are quite interesting.
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In a recent article in Annals of Clinical Biochemistry, a group over in the UK did an unusual thing - they audited their IQC (internal quality control) practices. The North Thames Audit and Quality Assurance Group use a questionnaire to assess the IQC practices in 54 laboratories in part of the United Kingdom. Here's the specific citation:
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?
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. -----
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) -----