The Westgard Rules

A covid19 view from Connecticut

Posted by Sten Westgard, MS

Here's a glimpse of the covid19 situation in Connecticut this morning:

"As of Thursday morning, the state’s public health lab in Rocky Hill had completed just 90 of the 1,200 tests it has received from the federal Centers for Disease Control and Prevention.

"'That’s horrible. We are vastly, vastly, vastly under-testing at this point,' Dr. Howard P. Forman, director of the health care management program at Yale School of Public Health, said Wednesday. 'Without testing, you don’t know what prevalence of disease you have in the community.'"

Later in the article it becomes more stark.

"Because the state lab only had the staffing capacity to run 20 tests a day, a decision was made to only test those whose condition had deteriorated enough to be hospitalized....

"By next week, the state lab will have more staff trained so it can complete 60 tests daily. A cohort of nine employees will take turns working three shifts, 7 days a week. But that’s the maximum capacity the state lab will have going forward."

60 tests a day isn't going to help us - we probably need 1,000 tests a day.

When you "lean" out the lab staff, cut costs, reduce funding for public health labs, and labs in general, you set yourself up for these kind of failures. We reap what we sow.

https://www.wnpr.org/post/connecticut-has-run-only-90-covid-19-tests-thats-problem?utm_source=Connecticut%20Public&utm_campaign=d1c5f37cb3-NEWSLETTER_YOUR%20START_20200302_COPY_01&utm_medium=email&utm_term=0_685fda1a0e-d1c5f37cb3-115441717&mc_cid=d1c5f37cb3&mc_eid=07420def70

 

Losing ground on HbA1c

Posted by Sten Westgard, MS

Buried in the proposed updates to the CLIA regulations was a concerning step backwards: rather than adopt the CAP/NGSP performance specification of 6% allowable total error, CLIA proposed adopting a much more permissive goal of 10%.

https://www.captodayonline.com/idea-to-ease-pt-standard-for-hba1c-stirs-alarm/

It has been good to see that most organizations have uniformly condemned this backward step. The decades of effort behind improving HbA1c testing is put at risk if this goal is degraded. There's no sense of how the CMS and CLIA regulations will respond to this feedback, but we can be optimistic that they will defer to the overwhelming consensus of the industry.

One last thing about Theranos

Posted by Sten Westgard, MS

I know you've probably already read the book, listened to the podcast, and watched the documentaries (and are eagerly awaiting the movie and the tv series), so you've had your fill of stories about Theranos. Really, since it became so popular in the mainstream media, we've had a lot less to comment on.

But one of the heroic whistleblowers, Erika Cheung, had something to say that I wanted to share (with her permission):

"I spent many long nights independently doing training on QC systems & Westgard rules when I worked at Theranos. Before reporting Theranos company to CMS, I tried to collect and present lots of evidence on how our QC systems were severely failing and it wasn't just my opinion, but violated basic QC procedures, Westgard rules, and was far from six sigma laboratory principles. I was fortunate to be a young scientist who stumbled upon all the content you all developed and was able to leverage it to understand how a company was endangering patients...."

(Erika, it's really you we all need to thank.)

Westgard in the News: Shaking up QC Frequency

Posted by Sten Westgard, MS

Clin Lab News latest issue has an article about Sigma metrics, Risk Assessment and QC Frequency, and how all three of these things are combining to change the paradigm on QC frequency:

https://www.aacc.org/publications/cln/articles/2019/june/challenging-the-status-quo-on-quality-control

 

NY Times Editorial Focuses on Failures in Medical Device Regulation

A recent New York Times Sunday editorial focused on the deplorable state of medical device regulation. We simply can no longer trust FDA clearances, particularly 510ks:

"Regulatory loopholes — some of which date to the dawn of device regulation and were not meant to be permanent — enable companies to bring new or “update"d” medical devices to market without testing them in human trials first. Companies need only to convince regulators that their products are similar to ones that are already approved, even if the other products are decades old or were subsequently pulled from the market. Eight years ago the Institute of Medicine advised the F.D.A. to abolish at least one of these loopholes, what’s known as the 510(k) pathway. It’s past time for the agency to heed that advice, and to ensure that no medical device intended for permanent residence inside a human body is used on patients without first being rigorously tested."

There's a balance that needs to be struck between speed to market and safety of the public. Right now the regulations are tipped too heavily in favor of the corporations.

https://www.nytimes.com/2019/05/04/opinion/sunday/medical-devices.html

Method Validation Matters

Posted by Sten Westgard, MS

https://www.evaluate.com/vantage/articles/news/snippets/healthineers-sinks-atellica-letdown

I'm late to the party on this story, but I think this illustrates an atrophy in our core laboratory skills. When a multibillion-dollar diagnostic manufacturer loses profitability due to the "longer than expected installations times" of its instruments, that's a telling sign we are losing our ability to validate and verify our methods.

For too long, labs have been out-sourcing these skills to the manufacturers, making that validation and verification phase part of the purchase of a new instrument. Or if they're not out-sourcing it, they are not training enough staff internally to handle the big instrument validation projects - where hundreds of tests need to come online in a very short period of time.

Our neglect of statistical training means we don't have enough skilled staff, either at the manufacturer or in laboratories, to complete the necessary validation / verification studies. Then it takes longer to get these instruments up and running. Certainly bad for profit, but possibly even worse for patients.

[An even worse scenario would be if the instruments are actually failing validation or verification... but we don't know that is happening here.]

It was pointed out that there isn't a pure causal relationship established in this article - that I'm being speculative about the reason installation is taking longer than expected.

There are other possibilities that could delay profitability, but most of them are less flattering to the manufacturer:

• The complexities of installing systems these days are much higher. But if that's true, isn't it foreseeable? Isn't it therefore possible for the company to either hire more staff for installation, or warn analysts that profitability will be delayed while installation is performed? If the company didn't know installation was going to be so complex, that's a failure of execution and implementation. If the company knew but pretended it wasn't going to happen, that's a failure of leadership and financial disclosure.
• A further follow-up, if the company is having problems installing 340-odd systems, what's going to happen when they scale up to the 1500+ systems that they claim they will achieve this year?

My speculation places the blame closer to the lab, for lacking the skills to be able to efficiently validate new instruments. That's something that's out of the control of the manufacturers, and less predictable. I'm trying to give the manufacturer more benefit of the doubt here. But if you prefer, we can go dark - and blame the manufacturer for all the problems.

Theranos: a postmortem

Posted by Sten Westgard, MS

At the LabQuality Conference, I presented a discussion of the lessons of Theranos:

Bad Blood: The Rise and Fall of a 9 Billion Dollar Diagnostic Disrupter and What the Profession of Laboratory Medicine Didn't Do (But Should Have) to Stop It

The link below is to the abstract of the talk.

https://www.labqualitydays.fi/wp-content/uploads/sites/2/2019/01/LQD19_Abstract_Westgard_Sten_1.pdf

Coming to Helsinki, February 7-8

Posted by Sten Westgard, MS

Coming to LabQuality Days in February. Join me in the cold north!

Are There Westgard Rules in Your Future? The Current Devolution and Future Revolution in QC Practices

Sten Westgard, Director of Client Service and Technology (Westgard Quality Control, USA)

07.02.2019 10:30 - 11:15

Auditorium 103 (Roche Diagnostics), session: Quality Control Reinvented?

Bad Blood: The Rise and Fall of a 9 Billion Dollar Diagnostic Disrupter and What the Profession of Laboratory Medicine Didn’t Do (But Should Have) to Stop It

Sten Westgard, Director of Client Service and Technology (Westgard Quality Control, USA)

08.02.2019 12:00 - 12:45

Auditorium 103 (Roche Diagnostics), session: Digital Health

Univants of Healthcare Excellence Award

Posted by Sten Westgard, MS

An opportunity to demonstrate your patient impact! If we face the reality that the laboratory future must involve a closer interaction with clinical care and outcomes, here's an award that focuses on that very thing. Demonstrate how your lab results improve care and benefit patients, and your healthcare organization will receive and award from a consortium of AACC, IFCC, HIMSS, Modern Healthcare and more: https://lnkd.in/dGBz5Fq hashtag#Univants hashtag#labfuture

[full disclosure: this award is sponsored in part by Abbott Diagnostics, a company with which Westgard QC has business.]

Theranos finally bleeds out...

Posted by Sten Westgard, MS

ICYMI, The Theranos saga is finally done. It's bled out, its hundreds of millions in funding depleted, dissipated, and the company will finally dissolve. Hat tip to John Carreyou's dogged reporting, and to other journalists like the Dark Daily who provided skeptical coverage rather than fawning admiration. https://lnkd.in/ebBSKPr