Category: generalist

Red Tape

I like debates so I’m going to start one and I hope people will comment below and get a dialogue going. How many pieces of paper do you have framed on your wall in the lab from regulatory bodies? If you are a reference lab that serves nationwide customers you may be putting up regulatory wallpaper! I have heard of more and more inspections in regards to laboratories.. My laboratory is inspected by CLIA, CAP, and AABB. With budgetary constraints the importance of the AABB certification has been discussed numerous times. I even feel myself that AABB is becoming more of a consulting company that publishes medically relevant treatment recommendations than an inspection body. I would like to see consolidation between CAP and AABB where the somewhat higher standards of AABB are adopted by CAP and laboratories would not have to pay separate fees for each.

Let’s take it a step further. If CLIA inspections are increasing are there rising tensions between them and CAP? What is making CLIA step up? Do they not trust the job that CAP is doing performing inspections of the laboratories? If CLIA inspections are becoming that difficult what do you as a manager/supervisor put your efforts toward to ensure you will be compliant no matter who inspects you? How does a laboratory go through 3 or more inspections a year and still stay on top of everything else? All these questions must be answered and quickly if you expect to have time to do what is required of you as a manager/supervisor. I don’t think too many laboratorians would care who inspects them, but I do think we would care about having one universal checklist that we can abide by and really dig in to what is important to keep the lab accurate and safe.

How are we expected to grow our business and serve our patients when we are constantly guessing on what checklist to abide by or who is coming to inspect us? We are consolidating in every other sector of healthcare to improve efficiency except in regulatory bodies. Is this just another consequence of big government or do we actually need them all? We should start the discussion and make our voices heard on what we feel we need from regulatory bodies to ensure we are doing our jobs as laboratorians. Are you as frustrated as I am? Or have I inadvertently started my career as a lobbyist for the laboratory field?  Comment below.

-Matthew Herasuta

Under the Hood

I like to keep some humor in the lab so when I see a technologist with a panel off a machine trying to troubleshoot an issue I will say “Uh-Oh, why do you have the hood up?” It’s a little tension breaker, especially if they are stressing about having their instrument down. It also acts as a little reset button so I can go through the troubleshooting steps with them. As technologists, we are modern day mechanics. We use instruments much more than we perform manual testing, and we are expected to be able to troubleshoot instruments that are more complex than the current day automobile.

Acquiring new instrumentation can be a lab changing experience. Each instrument has its quirks and special requirements. The vendors usually offer on site or even off site training for staff once the instrument is purchased. Who you send to these training sessions is just as important as the quality of training they receive. These sessions are where your staff will learn maintenance, operation, and most importantly troubleshooting. When your shiny new analyzer goes down, and it will, the time it takes to get it back up and running affects productivity, turnaround time, and staff morale. Nothing is more detrimental to a staff’s morale then coming into work and the first thing they hear is that the instrument they are on that day is already down. Having experienced that exact thing I can tell you it takes the wind right out of you.If it happens consistently you will see a decreased engagement by staff.

Whom should you send for analyzer training? You should have a good mix of talent and maybe some of the lower performing staff. This assures that you are keeping your talented staff engaged and shows weaker performers that you are invested in building them into a top performer. The question becomes, how do I make sure that the people I send get the most out of their experience? Let them know they will be responsible for presenting the material they learned to the rest of the staff once they get back from training. If any of your staff have an issue with that they are not the ones you should send. These small presentations will help with team building as well as solidifying the information for the key operator.

As leaders we must pick our key operators very carefully. When these choices become important is most likely when we won’t be in the office. Observe the staff that likes to troubleshoot instruments or that keep a level head once instruments are down. You want to make sure that once the hood goes up you have the best mechanic for the job.

-Matthew Herasuta

Reference Intervals vs. Reference Change Values

If we didn’t use reference intervals (RI), how would we know whether a person is “normal” or not? Or more accurately, how would we know whether a lab test result indicated health or disease? Reference intervals have been around as long as lab tests and they help clinicians diagnose and monitor a patient’s disease state. .

Most RI are developed using a specific patient population and should be used only with that population. However, some RIs are “health-based,” such as cholesterol and vitamin D. Both these analytes have RI that indicate what amount of the analyte should be present in a healthy individual, not how much is present in your specific population of patients. In general, health-based RI can be utilized in all populations, as long as the analyte assays are commutable. Thus these type of RI are often more useful than population-based intervals.

But should we be using reference intervals at all? One problem with population-based RI is that any given individual’s values may span a range that covers only part of the population RI due to biological variability. For example, an individual’s creatinine may be 0.6 – 0.9 mg/dL regularly. Since the RI for creatinine for his population is 0.4 – 1.4 mg/dL, a value of 1.2 mg/dL would not be flagged as be abnormal. However, 1.2 mg/dL may very well be an abnormal result for this individual We need to consider using reference change values (RCV) in addition to RI.

Reference change values are calculated values that are used to assess the significance of the difference between two measurements. Essentially, a RCV is the difference that must be exceeded between two sequential results for a change to be a significant change. The calculation requires knowledge of the imprecision of the analyte assay (CVA) and the biological variation (CVI) of the analyte. The formula for calculating RCV is: RCV=21/2 · Z · (CVA2 + CVI2)1/2 , where Z is the number of standard deviations for a given probability. Luckily, labs know the imprecision of their assays and there are tables available for biological variation.

It’s very likely that neither RI nor RCV by itself is adequate for interpreting analyte results. Using both may be a better alternative, especially using RCV for monitoring disease progression or therapeutic efficacy. Flagging sequential values that exceed the RCV—and reporting this change—should be considered.

-Patti Jones

Equipment Procurement in Resource Limited Settings

In the developing world, equipment procurement can be a huge challenge. Funding is usually the initial major road block. In countries where many people live on $2.00 per day, Ministries of Health and local hospitals do not have large budgets to buy necessary laboratory equipment. In such situations, well-meaning donors from developed countries may be inspired to donate their gently used equipment to labs in developing countries.

While this donation is certainly well intentioned, it does not solve the problem. Equipment donations often do not come with assisted installation, a maintenance package or end-user training. While it may be possible to receive technical support from various international companies in some of the larger cities throughout Africa, outside of a major city technical support is difficult to obtain. Therefore, without a clear maintenance package as part of an equipment purchase or donation, the machine may languish uninstalled. The analyzer could also be used for a period of time before an inevitable breakdown renders it inoperative.

Equipment donations often do not come with assisted installation, a maintenance package or end-user training.

The issue of voltage differences between the U.S. and many African countries creates another challenge when it comes to equipment procurement. Equipment that is manufactured for use in the U.S. will not have the correct voltage for use in many African countries. This is certainly a problem when it comes to donations from U.S. labs. When acquiring new items it is crucial that those involved in the procurement process know the voltage needs at the laboratory site.

Once the equipment challenges have been met, the next hurdle is reagent procurement. With both donor-provided machines and those purchased by the local government, MOH, or hospital, funding must remain available for reagents in order for the lab to continue using the machine. I have seen labs with beautiful, well-maintained machines sitting unused because there was no money to purchase new reagents. Without long-term funding for reagents and other supplies, the analyzer itself is ineffectual. No matter if it is the local government, hospital or lab staff, or a donor involved in the procurement of equipment, it is vital that equipment maintenance and reagent supplies be accounted for at all times. A brand new machine can do no good if there is not money to ensure that it keeps working.

Overcoming these challenges is certainly possible, but all players involved in equipment procurement must be conscious of every aspect of the process.

-Marie Levy

How We Can Make a Clinical Difference Despite Not Seeing Patients

People assume that I chose pathology because I didn’t like patients but this couldn’t be further from the truth. During medical school, I was a Schweitzer Fellow and volunteered at two free health clinics in the Philadelphia Asian community where I helped start hepatitis B screening and vaccination programs in populations with a high prevalence of this disease. I also served as the student director of my school’s migrant farm worker health clinic where we provided screenings and care to farm workers every summer. In fact, I often was asked to speak with patients because I could convince reluctant patients to comply with care.

But this doesn’t mean that I was the best medical student on the wards or in the clinics; in fact, far from it. Now that I look back, I was often too stressed to quickly triage what was most important to do clinically. But being a trained critical thinker, I could often reason out the answers. A couple of my residents thought that I wasn’t made for clinical medicine because I thought things out in a different way than most.

For an artistic and introspective person like me, I found my home in pathology. I need work that visually stimulates me and provides variety, challenges, and most importantly, enough time to take a breath, gather my facts, and think things through. Sometimes, even my physician friends joke that we are introverts who don’t like patients. They think that we sit at microscopes all day, can’t write prescriptions, make diagnoses in isolation, and prefer to release reports with the words “recommend clinical correlation”  so that other doctors can provide the actual care. All of these things are so untrue.

On my molecular pathology rotation, I was reminded how the pathologist and the clinical lab are integral to the complete clinical care of the patient. A transplant patient on anti-CMV prophylaxis was admitted for diarrhea. His labs were positive for both C.difficile and a very high CMV viral load. He was given antibiotics and an increased anti-CMV medication dosage before being subsequently discharged. He was again admitted a few days later with worsening diarrhea despite medication compliance. He was again C.difficile positive and his CMV load was now three times higher than his previous result. He was put on IV gancyclovir and a repeat CMV load ordered to assess therapeutic response before discharge with a prescription for the same dosage of valgancyclovir he was given on his previous recent admission.

Our techs always compare abnormal results with previous values, so my attending and I were notified of the elevated CMV viral loads. The techs in my facility cannot access patient medical records so I was responsible to work up this case. I’m often amazed at how often they pick up a serious issue even without access to clinical records– more than just looking at the number, they know that something is not quite right.

I noted that the patient had been on valgancyclovir with dosage increases for CMV prophylaxis since discharge from his transplant. His CMV load was previously undetectable prior to the recent admissions. I called the transplant surgeon and suggested CMV resistance genotyping based on the clinical history and blood was sent that day. As the experts in diagnostic medicine, we can impact clinical care even when we don’t physically examine the patient. We must serve as the bridge between the clinical lab and primary physician – both informing them of available diagnostics as well as suggesting appropriate tests – because care is more than just the numbers.

-Betty Chung

Passions and Pitfalls as an International Consultant, Part 1: What We Do and How We Do It

According to the dictionary and the ever-popular Wikipedia, the definition of a consultant is “a person who provides expert advice professionally.” These same sources define “international health” as “an area for study, research and practice that places a priority on improving health and achieving equity in health for all people worldwide. Global health focuses on determinants and distribution of health in international contexts from several perspectives including: the pathology of diseases and promotes prevention, diagnosis, and treatment…”

Describing my “avatar life” as an international global health laboratory consultant is both a lofty definition and a mouthful. When people ask what we do as consultants, it’s easy to say “we provide expertise, training and mentoring in laboratory operations, to help strengthen them in process improvements so countries can grow in their capacity to provide the quality of laboratory services needed to diagnose, treat and prevent diseases in their countries.”  What exactly does that all mean?

When a country invites a consulting team to work with them, the first steps are to identify what their particular needs are in their laboratory system. Sometimes it’s developing a classroom curriculum that helps prepare students for laboratory and pathology careers. Often it is preanalytical training so specimen integrity, supply chain, and transportation issues do not compromise results. Other times it is analytical process mapping to identify areas for operational improvements and use limited resources in the most effective ways. And in many cases, it’s helping a lab comply with accreditation requirements. This entails assessing, advising, coaching and mentoring in the areas of procedures and quality metrics.

When a country invites a consulting team to work with them, the first steps are to identify what their particular needs are in their laboratory system.

An in-country consulting project usually has multiple phases. Once a country decides their course of action and focus, a series of visits are arranged to meet the goals set by the country’s leaders and the CDC in their region. That coordination of effort helps maintain focus and leadership so the time and resources are used most efficiently. Consulting teams are then set up depending on the expertise needed, previous experience and familiarity with the country, availability, and other considerations unique to the project. When a team is assembled they work together on logistics, content, accumulating materials needed for the project, and coordinating their efforts. When the project finishes, the team continues to collaborate on follow up, reports, lessons learned, next steps, and sustainability issues. It’s all very fun and exciting. It’s also all hard work as my fellow consultants and ASCP staff teammates can attest to! And that same cycle is being done in multiple countries, multiple phases, and multiple times during the year. Shifting gears quickly and maintaining flexibility are key capabilities you must be able to pull out of your bag of resume tricks or you won’t survive to tell the story!

That is a summary of what we do and how we do it, but that’s just the standard operating procedure. The real purpose is the passion and dedication to improving the health and laboratory conditions alongside our international colleagues and partners. And the outcome? Evidence based results are proving each step makes a difference, and we are seeing growth and change each trip, each project, each step of the journey. Come to the ASCP Annual Meeting and see the progress being made and how the Global Outreach teams are working together!

Next time let’s talk about some of the “pros and cons” of what works…and what sometimes doesn’t. And if you are ever in Kazakhstan, be sure to order beshbarmak…which means “five fingers” because you eat it with your hands. The traditional dish is made of wonderful thick boiled noodles in an onion broth and chunks of a variety of boiled meat…goat, mutton, beef and yes, horse. And if you’re there in the spring, wash it down with the traditional drink of fermented mare’s milk.I don’t have a recipe…but I do have a wonderful friend there who will take you out for an authentic Kazakhstani meal! Contact me at bsumwalt@pacbell.net.

-Beverly Sumwalt

Who Regulates Laboratory Developed Tests?

A laboratory developed test (LDT) is any test that has been developed by an individual laboratory, often using instruments and/or reagents that have not been approved by the FDA for use as/in an in vitro diagnostic test. For example, measuring pH using a pH meter and pH calibrators from a scientific supply company is an LDT. So is performing a spun hematocrit,  measuring acylcarnitines by tandem mass spectrometry, or performing newborn screening on dried blood spots. Even using an FDA-approved assay for samples or in a manner not specified by the manufacturer makes that assay an LDT. If you look around your lab, you may find that you’re performing an LDT without really thinking about it.

Who regulates these tests? The FDA regulates in vitro diagnostic testing, and LDTs fall under their purview. Until recently the FDA has used “enforcement discretion” and has essentially allowed CLIA regulations and CLIA oversight to ensure proper validation and monitoring of LDTs. CLIA regulation Subpart K, Section 493.1253 gives the specific parameters that must be properly validated in any non-FDA-approved assay. CLIA also regulates the proper usage and control of LDTs, just like any test performed in the laboratory. Is it necessary for LDTs to be regulated more highly than this?

In June of 2010 the FDA announced its intention of taking a more active role in LDT regulation in the future. They also held a public meeting to discuss their increased oversight. All laboratories which perform LDTs will do well to monitor developments in this newly intended enforcement of the FDA’s role, and keep abreast of changes coming out in the regulatory environment for these tests.

-Patti Jones

On the Lab Medicine Website

Anyone who has worked in a laboratory for any length of time knows that animosity can exist between health care providers and laboratory staff. Dennis Ernst, MT(ASCP), Executive Director of the Center for Phlebotomy Education, recently spoke with Lab Medicine about this “wall” and how laboratory professionals can break it.

Listen to the podcast here.