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

Posted by Sten Westgard, MS

Laboratories in the US probably already know this: their healthcare institutions are getting hit with fines from CMS due to excessive 30-day readmission rates for three conditions:

• (AMI) Acute myocardial infarction
• (HF) Heart Failure
• Pneumonia patients

CMS is imposing increasing fines for hospitals that have excessive readmissions. Guess how many hospitals have been fined - and how much money they've had to pay back...

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

Posted by Sten Westgard, MS

There was some very interesting testimony given in front of the US Congress this week. Boeing and other FAA officials discussed their failure to adequately test the lithium-ion batteries found in the 787 Dreamliner. As you probably already know, on two of the Dreamliners, those batteries malfunctioned and caused fires, which then caused the entire fleet to be grounded.

In the New York Times, it was reported "Boeing’s chief engineer on the 787, Mike Sinnett, said the calculation that a battery would fail only once every 10 million flight hours applied to the design of the battery and did not include possible manufacturing flaws."

In fact, two battery failures and serious fires occurred after less than 52,000 flight hours. The risk was actually over 350 times higher than their estimate!

How could they be so wrong? More after the jump...

Posted by Sten Westgard, MS

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

As we wait for more details about EP23 and how CMS and CLIA will actually enforce the implementation of Risk QC, the latest morsels to emerge are quite tantalizing.

On the CLSI website, a Q&A has been posted. Here is one interesting bit:

"3. Is there a planned format for documenting the EP23 QCP to present to surveyors?
There is no specific format that is required for the presentation of a QCP. The example in EP23 and those currently being drafted for future education will present some options, but laboratory directors have flexibility in the formatting of their QCPs. There may be some elements, components, or data that the Centers for Medicare & Medicaid Services (CMS) will look for when assessing compliance, but nothing standard."

This is an interesting question and an even more intriguing answer. The new standard will have "nothing standard" about its implementation. Presumably labs that use the workbooks sold by CLSI will be able to fulfill any requirements for proper design of Individual QC Plans.

So why won't there be a standard QC Plan format?

Posted by Sten Westgard, MS

So we all know that Risk Analysis is coming to laboratories in the US. (click here if this is news to you). But Risk Analysis, particularly the FMEA technique (Failure Mode and Effects Analysis), is not new to healthcare. Outside the laboratory, plenty of healthcare practitioners have been performing FMEA.

So what do they think about this technique? Try and guess which one of these responses is from a someone in healthcare:

• "The jury's still out on the FMEA process because... has anybody evaluated FMEA as a tool for analysing risk? And it turns out there isn't... well why are we doing this process?... When all it is doing is bringing a few things to the surface, which is no bad thing, but it's not a validated process."
• "...Forget FMEA. It doesn't really work effectively, I don't think, and the scores are a hindrance rather than anything else, year... We wasted a lot of time on FMEA before we realized, this isn't actually working. Yeah, because I think you can get caught up on just the score, that's the thing."
• "The scoring in the FMEA teams need to be the same people, if you change half way through because of the highly subjective interpretation things change dramatically."

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

Laboratory Quality Control Based on Risk Management

Posted by James O. Westgard, Sten A. Westgard

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

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