LDTs: Public Perception

It seems like everyone is getting into the act these days, related to the regulation of laboratory developed tests (LDTs). Even politicians and lawyers are talking about LDT regulation. A recent online post (http://thehill.com/policy/healthcare/211250-lawmakers-push-fda-oversight-of-lab-tests) reported that several lawmakers are now writing to the Office of Management and Budget (OMB), asking it to quickly approve the FDA’s guidance document for FDA regulation of LDTs, in order to protect the public from the depredations of the evil lab people developing tests that will harm the public. That last clause is my paraphrase of course, but is not that far off what the post actually says.

The harm in posts like this is that the general public, including lawmakers and politicians, have no understanding of the laboratory field in general, and definitely no understanding of the regulatory environment that all reputable labs operate under. The majority of hospital labs and big reference labs are accredited and operate under the regulations of an accrediting agency including such agencies as CMS, CLIA, various State regulatory bodies, CAP and The Joint Commission. The combined regulations of these agencies result in labs which not only produce test results using good laboratory practice, but when these labs develop tests (LDTs) they do so meeting many regulatory standards already. FDA oversight of these labs is overkill, in my opinion.

Where FDA oversight of LDTs would be useful is in the plethora of start-up companies offering the public a variety of tests to diagnose disease, monitor their health, or determine their genetic code. Many of these labs have no accreditation and have used LDTs as a loophole for bypassing FDA regulation of their tests. In fact it’s likely that many of them are in need of regulation from some agency.

John Q. Public in general is just beginning to understand what a lab test is. He has no idea that he should be looking for an accredited lab, and asking for some sign that minimum standards were used to develop tests. He simply Googles his symptoms and gets 4 million options for lab tests he can have run to diagnose his disorder. Laboratory professionals have an obligation to try harder to educate the public. We need to be involved and be visible. FDA regulation of laboratory tests is a “hot” issue currently that is being picked up by the public. We should take every opportunity to set the record straight.

 

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-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

FDA Regulation of Laboratory Defined Tests

Yesterday the FDA announced its “intention to publish a proposed risk-based oversight framework for laboratory developed tests (LDTs), which are designed, manufactured and used within a single laboratory.”

Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said, “With today’s notification of the agency’s intent to issue the lab-developed test draft guidance, the FDA is seeking a better balanced approach for all diagnostics. The agency’s oversight would be based on a test’s level of risk to patients, not on whether it is made by a conventional manufacturer or in a single laboratory, while still providing flexibility to encourage innovation that addresses unmet medical needs.”

You can read the entire press release on the FDA website.

What do you think? How would this affect operations in your laboratory?

Getting Out of an Intellectual Laziness Slump

I’m currently listening to the Q&A session after a Big Data Analytics talk in the Grand Ballroom here at the American Association of Clinical Chemistry (AACC) Annual Meeting at the McCormick Place in Chicago. As a medical resident with an MPH and health economic and statistics training and someone who helped perform lab error analysis during my PGY1 year that culminated in a poster presentation at this meeting last year, I found this series of talks very interesting. I feel re-inspired. What I mean by this statement is this…I often find myself in intellectual laziness slumps and I need experiences like these to recharge – to find other people with similar interests who want to participate in such discussions and who can also support us through those times when we are uninspired (or lazy, which can depend on point of view).

I’m just over halfway through my residency training. I’m also preparing materials and gathering letters of recommendations to apply to fellowships very soon. I also have peripheral thoughts of needing to start studying for boards, but that’s lower on my list after fellowship applications and publication submissions that I’ve put off writing for far too long. It’s easy during this long journey to become overwhelmed in addition to uninspired or lazy.

During the day, I work hard to approach my residency service tasks because patient care seems more imminently involved. But I need to get back to devoting one day during the weekend on non-service but also important residency-related tasks on my things-to-do checklist because despite how it may seem, I’m also passionate about them as well. What gets me more excited than networking at conferences such as these, is the opportunity to talk with experts about shared interests and possible collaborative projects…or at least the start of a friendship/mentorship where we can help each other move our healthcare system forward.

On another note, at the end of the week, after AACC is over, I will remain in Chicago to serve as the junior (resident) member of the College of American Pathologists (CAP) Council on Education (COE). I’m looking forward to our Friday night meeting dinner where we also have discussions that re-energize me as well in terms of working together to transform our profession for the better. I always feel privileged to be able to “pick the brains” of others who are intimately and actively involved in this endeavor over the casual setting of a delicious meal.

So, are you in an intellectual slump? If you need encouragement, feel free to email me at chungbm@rwjms.rutgers.edu and I hope to pay it forward and help you out of your slump or connect (I’ve always been a consummate “connector”…a quality from my grassroots organizing days, I suppose) you with mentors who might inspire you. If you are going to be in Chicago in early September, I also recommend that you attend the CAP Residents Forum on September 9, 2014 – you can register at www.thepathologistsmeeting.org or better yet, contact Jan Glas, head of resident engagement for CAP, at jglas@cap.org  to become your program’s delegate and/or volunteer to serve on the credentialing committee and sign in delegates who attend the RF in September.

 

Chung

-Betty Chung, DO, MPH, MA is a third year resident physician at Rutgers – Robert Wood Johnson University Hospital in New Brunswick, NJ.

 

Test Utilization Made Easy

Just kidding–this sort of thing isn’t easy. Right?

Not so fast. A few days ago I attended a session on test utilization management at the AACC meeting in Chicago. While the issue is quite complex–it’s not just a matter of right test/right patient/right time (which is tough enough already)–the speakers gave the audience a few relatively easy ways to improve test utilization.

  • Find and fix ordering errors
  • Identify tests with limited clinical use and eliminate them from your menu
  • Suggest a better test for the same disease/condition
  • Identify and correct deviations from established guidelines
  • Investigate odd patterns. (For example, if General Hospital generates 5% of your business but accounts for 70% of test X.)
  • Monitor year-to-year practice variations

As I said, this issue is quite complex, but implementing even a few of these changes could improve your lab’s bottom line.

 

Swails

Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.

 

First-RISE

There had been talk about it for some time. We even discussed the topic during the meeting of an ASCP committee that I served on previously. It’s the First-RISE. So, all of us senior residents know the RISE but this month, ASCP administered a slightly different test that is meant to test the new PGY-1 in their baseline knowledge compared to what is required for AP/CP training. Sometime next month, they will receive their test results just as we did our RISE scores this past spring.

I know that the First-RISE is not merely giving the RISE that we all know and love/hate to the first years…and that there are some topics on there that we just don’t see on our version of the RISE. But the idea is the same – to identify areas of strength versus weakness. Programs and residents can then take this information to devise personalized study plans or lists of topic areas to focus on more intently.

For those of you who are checklist people and/or disciplined studiers who stick to their “plans”, what is the best way to study? Do you think that First-RISE will assist program directors in helping to start off their first years on the right track? Do you think that First-RISE is meaningful?

 

Chung

-Betty Chung, DO, MPH, MA is a third year resident physician at Rutgers – Robert Wood Johnson University Hospital in New Brunswick, NJ.

Fresh Ideas

It’s always interesting to me how you can “look” at something for so long you no longer “see” something right in front of you! Take advertising for instance…we can all recognize the fast food chains advertising signs, but if asked whether or not one is hanging in your patient waiting room, you might be surprised that you’d walked by it so many times you just don’t see it!

I had the privilege to do a walk-through in a small, but efficient and organized, critical access hospital laboratory in the past few days. As we looked in their storeroom, we were ushered past a row of neat, clean, personally labeled lab coats—obviously one for each staff member. And, on a shelf just near them were a couple of neat, clean, and organized rows of tennis shoes…what?? Lab shoes!

I’ve seen this in other countries where laboratorians have “street shoes” and “lab shoes”—often because they wear sandals in tropical climates or boots in frosty climates—and they work in labs where the instance of public health contaminates tend to be very high. Hence the safety of not taking home any lab detritus on your shoes.

I’ve not seen this safety practice in this country, or at least not often—which makes me wonder if I have just “walked by” this best practice in laboratory safety so many times that I just don’t see it as often as perhaps it is being implemented. My “kudos” to the laboratory staff who pointed theirs out for me, they are certainly showcasing a best practice—and I’m reminded that perhaps it never hurts to look more closely at things we take for granted in our laboratories! If your lab has a best practice in laboratory lab coat/shoe/personal wear safety, I’d love to hear about it; please email me at beverlysumwalt@gmail.com and I’ll be happy to share it with your colleagues in my travels both at home, and globally.

Cheers!

 

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Beverly Sumwalt, MA, DLM, CLS, MT(ASCP) is an ASCP Global Outreach Volunteer Consultant.

Validate, Transfer or Establish: What Are You Doing with Your Reference Intervals?

Reference intervals are absolutely necessary for proper interpretation of laboratory tests, and yet obtaining appropriate reference intervals can be the bane of the laboratory. I mentioned establishing, validating or transferring reference intervals in an earlier blog post, but didn’t talk about exactly what these are and when to use which one.

Establishing a reference interval is exactly what it says. A reference interval must be established if a new assay has never been performed in the lab and there is no current reference interval to start with. Most often, laboratory developed tests (LDTs) that are developed from scratch will require the establishment of a reference interval. To do this, ideally 120 samples from healthy individuals for each sub-population (gender or age sub-group) is used, although there are methods available using smaller sample sizes. Samples used to establish reference intervals may be collected a priori, meaning they are collected from individuals for the express purpose of establishing a reference interval, with well-defined inclusion or exclusion criteria used, or a posteriori, meaning they are samples collected and analyzed first, with exclusion criteria applied after statistical analysis.

Validating a reference interval is the easiest way to obtain one, and is what is hoped for when a new method is introduced. Validation is usually used when a new instrument or method replaces an old one, and reference intervals are currently in place. A patient correlation study is done using at least 20 patients. The data is analyzed with regression, bias and correlation statistics. If the bias and regression are acceptable, the reference interval that is currently in place will also work with the new assay. The interval has been validated and can be used with the new method.

When a validation study is done for a new method and the results of the data analysis are NOT acceptable to validate the assay, then a transference study is necessary. A transference study is simply an extended correlation. More than 20 patients are used, enough to determine the amount of bias between the two methods. Then the old reference interval is adapted to fit the new method, using the amount of bias determined. For example if the new method measures 15 percent higher than the old method, the reference intervals will be increased 15 percent across the board. Transference is recommended to be performed once. If another new method is brought in for that analyte, rather than transfer the reference interval again, a new interval should be established.

All three of these methods for obtaining reference intervals are useful in the right situations. It is important to know when to use which method.

 

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-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.