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
James O. Westgard, PhD
[Editor's note: this essay contains some discussion of politics]
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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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.
Sten Westgard, MS
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 NIAHOSM (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. -----
Posted by Sten Westgard, MS
Recall back in July we mentioned a raffle for a "Westgard Rules" Bobble-head?
Well, the Bobble-heads took a bit longer to arrive (that boat from China is slower than we thought), so we can now announce the winners...
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Posted by Sten Westgard, MS
It's almost mandatory that any presentation or report discussing patient safety references the landmark IOM report of 2000: To Err is Human - Building a Safer Health System. The takeaway quote from this report is that US hospitals were causing 44,000 to 98,000 deaths that were otherwise preventable. That is, hospitals were causing tens of thousands of avoidable deaths.
A recent paper has attempted to revise that estimate, focusing on Preventable Adverse Events (PAEs) that contributed to the death of patients. Can you guess how lethal US hospitals are now?
- 4,000 to 10,000 PAEs per year
- 44,000 to 98,0000 PAEs per year
- 100,000 to 200,000 PAEs per year
- 210,000 to 440,000 PAEs per year
The answer, after the jump...
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Posted by Sten Westgard, MS
A lot of interesting studies coming out this month, unfortunately none of them with encouraging news about the US healthcare system.
The latest, from Sunil Eappen, MD, Atul Gawande, MD et al, Relationship Between Occurence of Surgical Complications and Hospital Finances, JAMA, April 17, 2013, Vol. 309, No. 15 1599-1606
Take a guess: do US hospitals make more money when things go wrong, or less?
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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...
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Posted by Sten Westgard, MS
Can you guess which of these categories is the leading source of successful malpractice claims?
- Surgical mishaps
- Obstetrical problems
- Medication errors
- Anesthesia disasters
- Diagnostic errors
- Treatment errors
- Something else entirely?
The answer, after the jump...
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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.
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