Posted by Sten Westgard, MS

Now that we know EQC will officially be phased out and instead Labs will have to develop QC Plans through Risk Analysis (as explained in CLSI's new guideline EP23A), some of the waiting is over. EQC, which was fatally flawed from the start, is going to go away.

However, the exact regulations about QC Plans and Risk Analysis have yet to be written (or, at least, are not yet known by the general public). What makes this more uncertain is that EP23A is only meant as a guideline, and the Risk Analysis approach discussed in the guideline is only meant as a possible example. Risk Analysis is a long-established technique (outside the medical laboratory) and has many different formats and levels of complexity. Even between EP18 and EP23, there are discrepancies between the Risk Analysis recommendations (EP18 recommends a 4-category ranking of risk, while EP23 recommends a 5-category approach).

So while we're waiting for the other shoe to drop (in the form of detailed regulations and accreditation guidelines governing Risk Analysis), we might as well talk about what questions those rules will have to answer...

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?

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.

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
Updated 11/7/08

posted by Sten Westgard, MS

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

On August 16th of this year, CMS issued a new memo about IQCPs. If you recall, IQCP stands for  Individualized Quality Control Plan, and it's part of the new Risk QC being proposed by CMS as a replacement for EQC. The CLSI guideline EP23, which came out about two years ago, laid out the broad outlines of this new policy, but we have been waiting for the government regulations to spell out the specifics of implementation and interpretation.

Posted by Sten Westgard, MS

The biggest news coming out of the AACC/ASCLS conference in Houston was made by Judy Yost of CMS.

So the new future is IQCP. Remember what that stands for?

• It's Quickly Coming to Pass
• I've Quit Caring about Performance
• It's Quackery, Chaos, and Pablum
• I'm Quietly Compromising my Processes 

Posted by Sten Westgard, MS

Dr. Westgard had the pleasure of taking part in the Bio-Rad industry workshop on July 17th, which was focused on Quality Control for the Future - Risk Management EP23 for Laboratories.

Can you guess what Dr. Westgard had to say?

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Heads up. There's a new abbreviation in town: IQCP

Can you guess what IQCP means?

1. Information Quality Certified Professional
2. Individualized Quality Control Plan
3. Intelligent Quality Control Plan
4. Incoherent Quality Control Plan
5. Ill-conceived Quality Control Plan

The answer, after the jump...

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

Posted by Sten Westgard, MS

Now that the age of the IQCP is here, laboratories are grappling with the time and effort it takes to build their Individualized Quality Control Plans. How long should it take to build an appropriate IQCP?

• 40+ hours
• 21-40 hours
• 11-20 hours
• 5-10 hours
• Less than 5 hours?

How much time has it taken for you? How much time do you think it should take?

Posted by Sten Westgard, MS

Another shoe has dropped in the regulatory world. Recently, CDC/CMS issued their "how-to" guide for IQCPs, CAP dropped their checklist for IQCPs, and now the other major deemed accreditor has put out their IQCP guidelines: The Joint Commission.

New and Revised Standards for Individualized Quality Control Plans (IQCP) Prepublication Requirements

So what is JCI doing about IQCPs? Join us after the jump