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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By Sten Westgard, MS
Posted by Sten Westgard, MS
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...
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Posted by Sten Westgard, MS
With sincere thanks to Carolyn Maurer, the Director of the CAP 15189 program.
As the new IQCP regulations kick in, it's been interesting to see the international reaction to them.
I admit that I thought the IQCP impact would be contained within the US, that contagion would not spread to the international community. After all, IQCP is only a required option for labs within the US, and then only required for labs that seek to find a replacement to their now-outdated EQC policies. For labs that don't want to reduce their QC frequency below once a day, there's no need to create an IQCP at all.
But the situation appears to be more complicated. CAP, which has a significant international presence, is rolling out IQCP to all of its members, not just its US customers.
In light of that, I asked CAP how it balances the IQCP reduced QC frequency with the ISO 15189 standards. Their answers, after the jump...
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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.
So what is JCI doing about IQCPs? Join us after the jump
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Posted by Sten Westgard, MS
We knew that the accreditation agencies needed to develop their own policies to handle the new CMS IQCP regulations. CAP gets the prize for being first out of the gate with some practical steps, as well retaining some safeguards for quality.
IQCP, if it's not already burned into your head, stands for Individualized Quality Control Plan, and this is supposed to be the replacement for the EQC policies which have been in place for several years. The EQC policies are being replaced, you may recall, because they are scientifically untenable. It was hoped that IQCP was going to be more scientifically robust. That remains to be seen. CAP is attempting to assure that it will implement the CMS IQCP regulations but also provide a higher level of quality assurance than that low bar.
More after the jump.
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Posted by Sten Westgard, MS
A recent news investigation produced a litany of laboratory errors. Can you guess which of these lab errors actually happened?
- a blood screening test fails to identify a critical blood disorder in a pregnant woman. Her child dies 3 weeks after being born
- an HIV test falsely identifies a husband as HIV positive. The couple separates, the wife unwilling to trust the husband anymore.
- a paternity test sample gets switched: a father is falsely told that his daughter is not his biological child. The family splits up. Nearly 4 years later, the laboratory contacts him and tells him he was the father. The father-daughter bond remains broken.
The answer, after the jump.
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
While traveling in the middle east recently, I was asked by a colleague about the new US IQCP regulations, specifically how to implement them in their foreign laboratory.
Frankly, I was a bit shocked. I didn't realize that anyone outside the US was paying attention to the IQCP roll-out.
But it does raise a good question: Is IQCP a global necessity? Or merely a US idiosyncrasy?
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Posted by Sten Westgard, MS
Dr. Westgard talks about the new era of QC at the Thermo Fisher workshop.