management/administration – Page 21

What’s Your Number?

When I ask “what is your number,” I mean “what is the percentage of time you spend on the bench versus time in the office doing administrative work.” In my laboratory we currently have a chemistry supervisor on extended leave so myself and the hematology supervisor are 90/10 bench/office. I know what you’re thinking, how do you do the administrative portion while working the bench that much? The answer is simply, we can’t. Unless I work 60 hour work weeks there is no humanly possible way to be able to work on the bench and get done what I need to in the office. Prioritizing the administrative duties and taking advantage of slow days on the bench is the number one reason why I am somewhat successful at getting things done.

The biggest challenge I face is competency. One of CLIA’s six competency guidelines is physically watching each technologist/technician perform each test that is on our test menu. So let me break this down. I have 15 employees that need to complete competencies. We perform gel testing in blood bank as well as LISS, PEG, and Pre-warm screens in tube if necessary. Let’s round all of those tests to 45 minutes. 15 employees times 4 different methods is 60, times the 45 minutes is 2700 minutes, or 45 hours. Now don’t forget that I am in the hospital setting which is 24/7 so I have to be available for second and third shift if I want to make sure those employees are competent. So for simplicity sake I’m going to round those hours up to 48 which makes six 8 hour days of competency. If I get two office days a month, competency will take me four months to accomplish and that isn’t counting my other duties. This is also assumes uninterrupted time which we all know happens once a millennia. These are just four tests as well; we perform many others such as antigen testing, long crossmatching, etc. When looking at this it can be overwhelming but there are ways to accomplish the impossible without killing yourself.

One way to help yourself out is to look at the CLIA definitions of who can be a technical supervisor for competency testing. Chances are you have more than one employee who qualifies and as long as you sign them off as competent they can sign off other employees. This can drastically cut down the amount of time you need to spend individually with each employee. Another way is to have the employee’s videotape themselves performing the tests while explaining out loud what they are doing. This not only confirms their competency but you can watch back the tape at your leisure as well as show inspectors if they ask how you satisfy the observation portion of the competency. I now ask you in the comment section below write down your numbers and let me know what your biggest challenges are and some possible solutions. We can help each other out, and share in the continuous struggle. So, what’s your number?

–Matthew Herasuta, MBA, MLS(ASCP)CM is a medical laboratory scientist who works as a generalist and serves as the Blood Bank and General Supervisor for the regional Euclid Hospital in Cleveland, OH.

CDC Update on the Ebola Outbreak

Yesterday Dr. Tom Frieden, Director of the Centers for Disease Control in Atlanta, briefed the media about the current Ebola outbreak in Africa and called for an immediate global response to the outbreak. “There’s nothing mysterious about what we need to do,” says Frieden. “The only real question is whether we’ll do it fast enough.”

Read the full transcript on the CDC website.

Read Maryn McKenna’s astute summary on the Superbug blog.

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.

-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.

Is Your Lab Ready to Give Results to Patients?

In February I wrote about the Department of Health and Human Services regulation that amends the Clinical Laboratory Improvement Amendments of 1988 and the Health Insurance Portability and Accountability Act of 1996 in regards to reporting of patient results. The deadline for implementation is fast approaching–9/27/2014–and so I’m curious as to how prepared laboratories are for this change.

Is your lab ready? What sort of changes have you made, if any? And do you see this as a way for pathologists and laboratory professionals to become a bigger part of the healthcare team? Or is it simply going to make everyone’s life harder?

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

Test Utilization: A Deeper Look

The test utilization seminar I attended at the AACC annual meeting (I talked about it here) presented fascinating information that I’m going to try and sum up for you.

Test utilization isn’t just about ordering the right test, making sure the order entry system is efficient, or even about the accuracy of the test. Sure, all those factors are important, but patients aren’t treated by laboratory data. They’re treated by doctors, and those doctors are human. Humans are irrational and make mistakes for all sorts of reasons like fear, cognitive limitations, and social complications. Medical decisions are incredibly complex and driven my mounds of data. This complexity contributes to medical errors.

I found this notion counter intuitive—one would think that more data would mean better decisions. However, a study conducted by the CIA on horse race prediction found that when analysts were given more data, the accuracy of their predictions didn’t improve. However, the analysts had more confidence in their predictions. What does this mean? Just because your doctor runs fifty tests doesn’t mean he’ll diagnose you accurately. It probably means, though, the doctor will be confident they are right.

Another tidbit from the seminar: diagnostic error is usually the convergence of several different factors that are organizational, cognitive, and technical in nature. Any laboratory professional who has dealt with major errors has seen this in action—an event investigation will usually reveal that anything that could go wrong did, and that’s why the event occurred. The authors of this particular study did note that technical/equipment problems contributed to only a small fraction of diagnostic errors. This speaks to the integrity, critical thinking, dedication to quality that laboratory professionals possess.

If you want to read more, here are a few of the studies mentioned during the talk:

Diagnostic Error in Internal Medicine http://archinte.jamanetwork.com/article.aspx?articleid=486642

CIA: Do You Really Need More Information? https://www.cia.gov/library/center-for-the-study-of-intelligence/csi-publications/books-and-monographs/psychology-of-intelligence-analysis/art8.html

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

Right Test, Right Time, Right Patient: The Age of Lab Stewardship

Last week, I attended the American Association of Clinical Chemistry (AACC) conference in Chicago. I attended molecular diagnostics talks but also talks about quality improvement, the use of “big data,” and lab stewardship. I have an interest in QI as my AACC poster presentation last year was on lab interventions to reduce lab error frequency and I am also a resident on my hospital’s performance improvement committee.

So, what exactly is “big data?” It’s a word that we are hearing more often in the media these days. It’s also a term that is increasingly being used in our healthcare systems. In 2001, analyst Doug Laney defined “big data” as the “3 V’s: volume, velocity, and variety” so that’s as good a point as any to start deconstructing its meaning.

Volume refers to the enormous amounts of data that we can now generate and record due to the blazing advancement of technology. It also implies that traditional processing matters will not suffice and that innovative methods are necessary both to store and analyze this data. Velocity refers to the ability to stream data at speeds that most likely exceed our ability to analyze it completely in real-time without developing more technically advanced processors. And finally, variety refers to the multiple formats, both structured (eg – databases) and unstructured (eg – video), in which we can obtain this data.

I’m always amazed at the ability of the human mind to envision and create something new out of the void of presumed nothingness. Technology has always outstripped our ability to harness its complete potential. And the healthcare sector has usually been slower to adopt technology than other fields such as the business sector. I remember when EMR’s were first suggested and there was a lot of resistance (in med school, not that long ago, I still used paper patient charts). But now, healthcare players feel both pressure from external policy reforms and internal culture to capture and analyze “big data” in order to make patient care more cost-effective, safe, and evidence-based. And an increasing focus and scrutiny (and even compensation) on lab stewardship is a component of this movement.

I often find myself in the role of a “lab steward” during my CP calls. The majority of my calls involve discussing with, and sometimes, educating, referring physicians about the appropriateness of tests or blood products that they ordered…and not uncommonly, being perceived as the test/blood product “police” when I need to deny an order. But lab stewardship goes both ways. And these days, the amount of learning we need to keep up with to know how to be a good lab steward is prodigious, daunting, and sometimes, seemingly impossible.

So do you believe in this age of lab stewardship that it’s the job of the pathologist to collect and analyze “big [lab] data” and to employ the results to help ordering physicians to choose the right test at the right time for the right patient? Or is it a collaborative effort with ordering physicians? With patients? How do you foresee that the future practice of medicine needs to change from standards of practice currently?

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

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.

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.

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