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
Updated 11/7/08

posted 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

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

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?