Laboratory Testing in A High-Containment Facility

The team at Emory that cared for the patients infected with the Ebola Virus have published a paper on Lab Medicine about laboratory testing within a high-containment facility. You can read the entire paper on the Lab Medicine website.

Biobanking and Sample Stability

A common question often asked of laboratory professionals is the length of time an analyte is stable in a sample. This question may arise simply because a sample has been delayed reaching the lab, but can also be asked in the case of adding on a test to an existing sample a day later, or a week later. Most laboratory professionals can tell you the stability of an analyte in a patient sample, at both ambient temperature and refrigerated, because assay manufacturers perform those short term stability studies when they create their tests. And many of them also include the stability of the analyte in a frozen sample. Beyond this information, it’s harder to find stability information for analytes.

Some stability information can be found at large reference labs, as they have often done their own stability studies and may know how stable an analyte is when frozen for a month, or for 6 months. The really difficult information to come by is how stable an analyte is for really long term storage. This is a question that needs to be answered as biobanking becomes increasingly popular.

Biobanking is the use of repositories to store biological samples, usually for use in later research. Biological material can be stored frozen in many forms, including tissue, cell culture, serum and plasma and dried blood spots. Determining how stable an analyte is under long term storage conditions is important in order to be able to use those samples for research in the future. And yet sometimes determining the long term stability is itself difficult. For example, if a person wished to see if albumin was stable frozen at -80 degrees for 25 years, the difficulty would be in having the same assay available 25 years apart to perform both sets of measurements. (Not to mention the personnel). Measurement technologies change over time, some very rapidly, making longitudinal studies difficult.

The design of studies utilizing biobanked samples will be important. Even when not performing longitudinal studies, if a sample has been stored for 10 years frozen in a biorepository and I remove it and measure the calcium, how do I know the calcium present is the amount of calcium that was present when the sample was stored? If I have knowledge of the patient the sample came from, I could use this data to say that in stored samples, patients with X disease have higher calcium than patients without disease, but I could not necessarily make the jump to what is true in vivo, without knowing how stable calcium is upon long term storage.

Often stored samples are used for measuring analytes that weren’t able to be measured when the samples were originally stored. In those cases, you may be able to infer stability if the amount of analyte measured in the stored samples is comparable to the amount measured in fresh samples.

Biobanking is a growing enterprise, and stability studies will need to grow along with it.

 

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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.

Ebola Information for Laboratory Professionals

While it’s unlikely you will ever encounter a case of Ebola, it’s best to be prepared. The CDC has a health advisory page full of information, including specimen requirements for Ebola testing. The laboratory’s first step is to contact their state health department.

 

 

CDC Interview About Ebola

Medscape interviewed the CDC about the current Ebola outbreak. In it, the CDC reiterates that healthcare workers are at particular risk for infection. While the interview doesn’t specifically mention laboratory professionals, of course they are included in that risk group. Protect yourself using standard precautions (sometimes called contact or droplet precautions). This includes gloves, gowns, face mask, and eye protection when handling specimens from a potential victim.

You can read the entire interview here.

 

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.

Product Recalls and Patient Safety

Manufacturers issue product recall notifications when their product doesn’t perform as it should. A few examples include control materials not performing as expected, instrument software malfunctions, or in-vitro diagnostic devices (IVDs) such as glucometers and hemoglobinometers failing to perform. There are different classification of product recalls according to the Food and Drug Administration (FDA).

  • Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violate product will cause serious adverse health consequences or death.
  • Class II recall: a situation in which use of or exposure to a violate product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
  • Class III recall: a situation in which use of or exposure to a violate product is not likely to cause adverse health consequences.

In some cases, these situations also are considered recalls:

  • Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems would be a market withdrawal.
  • Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm.

These notifications require acknowledgement of receipt as well as an action plan to assess if the malfunctioning material or instrument affected patient care. Recalls need to be taken seriously due to the potential of patient harm resulting from inaccurate test results. It’s not uncommon for laboratories to receive non-compliance findings in this area, usually due to lack of documentation and proof of action to assure patient safety.

The Joint commission standard MSE.8.2 requires that an organization has a product/equipment recall system. Element of performance 11(EC.02.01.01) requires that hospitals have a way to respond to product recalls and notices. Accordingly, each laboratory needs to establish a product recall system that includes documentation of any actions taken in response to a Letter of Recall notice. This documentation should include distribution lists to departments in the hospital, acknowledgment of read/action from department (s), initial/ date, identification of the returned/ recalled products affected or confirmation that no products were affected per manufacturer’s instruction, and the patient safety assessment study conducted that’s reviewed and approved accordingly by the department manager and/or quality assessment manager. Management should insure that none of the recalled products were used to conduct patient tests. If the products were used and the resulting potential result inaccuracy might harm patients, communication to the providers and/ or patients, needs to be considered.

 

Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.

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-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

My 3Ts: Trials and Tribulations of Technology!

Like so many others, I figured it wouldn’t happen to me. Like countless others, I have been through the fires of Hades trying to straighten out a “hacked” email account. Like numerous others, I’ve come away from the experience knowing more and enjoying less of my techno-challenged universe! Changing your email address is about as complicated as changing your DNA. Consider, it’s not just closing down “yahoo” and opening up “gmail.” It’s re-capturing the twenty-year list of professional and personal contacts that were compromised and will never be found again. Or the list of archived documents that hold the history of your collective files, reference materials, all the “stuff” you keep. Never mind the cartoons and pictures…I gave up on those long ago.

After my gnashing of teeth and ultimate resolve to fix the issue, it occurred to me what a huge problem it would be to re-create a “hacked laboratory.” In the laboratory, it would be like wiping out every send-out log, every result, every known micro or blood bank patient history, every phlebotomy encounter, and every patient demographic that exists. Well, you get the picture! It’s a “do over” at the highest level. Back-up and clouds aside, it would be very difficult. What computers have done FOR us is to standardize and streamline data collection, improve error rates, and decrease turnaround times for diagnoses, test results and treatment. All VERY good things. I would also propose that….if a process is broken or not working, adding computerized technology only speeds it up and makes it go really really fast….it doesn’t fix the process! Technology is an enabler, and should be used to enhance where needed. As laboratory professionals, in addition to learning the skills of “medical technology”, we are also rely on LIS systems, HIS integrations, and the other “non-medical technologies” that make our systems more efficient. I encourage us all to remember that we must also focus first on improving our processes, so that when they go fast, they also go well. Having someone hack my email forced me to look at my processes…and indeed, some of them were going fast but needed improvements!

Technology is what we do. Technologist is in our title and licensure. It seems to me that science geeks, which most of us are, weren’t prepared to be computer geeks as well….and therein lies the hope for an even better next generation of “medical technologists.” Are we indeed still medical, still seeking continuous improvement and quality processes for our patients, or are we just highly computerized technology teams who can deliver results really fast? Something to ponder…

Cheers!

 

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