Posted by Sten Westgard, MS

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

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.

The Hamilton, Ontario, AQC Workshop

Posted by Sten Westgard, MS

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:

Posted by Sten Westgard, MS

By Sten Westgard, MS

By Sten Westgard, MS

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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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. -----

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.

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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