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
Antwerp participants vote on meeting conculsions
As some of you know, the Quality in the Spotlight conference has one dinner that is infamous for its limerick contest. Finlay MacKenzie of the UK presides as the Master of Ceremonies, and all diners are invited to participate in constructing a limerick based on the events of the first day of the conference. Yes, that's right - try to turn statistics into lyrical poetry. A very difficult feat indeed.
And who was 2016's winner, you may ask?
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Posted by Sten Westgard, MS
The news hasn't been getting any better over at Theranos. Since the Wall Street Journal pierced the facade on Theranos' promise of revolutionizing the lab test industry, there have been additional stories that Walgreens is seeking an exit from their partnership, that some of their premier clinical partners, Intermountain Healthcare and Cleveland Clinic, have not even started work on any validation studies with Theranos technologies, and that Capital BlueCross has put a stop to Theranos blood-drawing at the insurer's retail store in Pennsylvania.
But that's nothing compared the release of the full, but redacted, CMS inspection report of Theranos' Newark, California laboratory.
Earlier, we had seen the top sheet of the report, noting five major violations that meant Theranos was putting its patients in "immediate jeopardy."
The full report, more than 121 pages long, is as bad an inspection report as I have ever seen. More explanation of this, after the jump...
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
I had the pleasure of taking part (albeit remotely) in the Quality at the Crossroads conference in Alexandria, Egypt.
As part of my session, we took questions from the audience, and I thought I would share a few of them with you, as well as a few of the "wrinkles" that labs in Egypt experience that we in the US do not. So here are the questions:
- How frequently should I measure Total Error and Measurement Uncertainty?
- Can I resort to comparing my EQA result to allowable bias when EQA result is violated and declared incorrect due to tight SD of comparator group?
- When using a new manufacturer’s QC, we should establish our own mean and CV, but it would result in tight CV and shift after 20 days. What are the recommendations for this? Is it better to wait more days to establish CV?
Some answers, after the jump...
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Posted by Sten Westgard, MS
The IATA (International Air Transport Association), whose 260 member airlines comprise 83% of global air travel, released their statistics on 2015 airline safety.
Can you guess how safe it is to travel? What was the global jet accident rate?
- 0.32 per million flights
- 0.22 per million flights
- 0.12 per million flights
- 0 per million flights
The answer, after the jump...
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Posted by Sten Westgard, MS
A recent op-ed in the New York Times by Dr. Robert Wachter as well as an interview with Don Berwick in HealthLeaders Media broached a taboo topic: is healthcare measuring too much?
'[T]he measurement fad has spun out of control. There are so many different hospital ratings that more than 1,600 medical centers can now lay claim to being included on a “top 100,” “honor roll,” grade “A” or “best” hospitals list. Burnout rates for doctors top 50 percent, far higher than other professions. A 2013 study found that the electronic health record was a dominant culprit. Another 2013 study found that emergency room doctors clicked a mouse 4,000 times during a 10-hour shift. The computer systems have become the dark force behind quality measures.'
How Measurement Fails Doctors and Teachers, New York Times, January 16, 2016
As the global debate over establishing the best error models and performance specifications rages, laboratories are probably asking themselves the same questions that the doctors are asking: how many metrics are too much?
A possible answer, or at least some more questions, after the jump...
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Can you guess just how bad US healthcare is at making the right diagnosis?
Is the error rate in the US related to diagnosis
- 5%?
- 10%?
- 6 to 17%?
- all of the above?
The answer, 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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