Harmonization

What does “harmony” mean to you? And how does it apply to lab testing?

One of the biggest problems that arise where lab testing is concerned is that tests run in two different labs will give you two different results unless the labs happen to be using the same equipment (and sometimes even then the results won’t match!) This is a huge problem for doctors of patients who use different laboratories for their testing or patients who move across the country and need to continue following lab test results.  A prime example of this dilemma is the current state of T4 testing. The same CAP sample when analyzed using different assay methods for thyroid stimulating hormone (TSH) can yield results which range anywhere from 2.66 to 8.84 mIU/L. Although CAP samples are not always commutable with patient samples, thyroid testing on patients shows this same lack of harmony.

This example underscores the need for harmonization. In our increasingly small world, where nearly everyone will soon be using the electronic medical record, and all lab results on a patient will be in one place whether they were all performed at the same place or not, it will be paramount that the lab results for any given test can be compared. Efforts to date have successfully harmonized several important analytes, including creatinine (IDMS-creatinine), cholesterol and hemoglobin A1c.  Efforts are on-going to harmonize vitamin D assays against the NIST standards. These harmonization efforts took a massive amount of coordination and work between the in vitro diagnostic industry, regulatory agencies and laboratory and clinical societies.

Laboratory professionals have long recognized this problem, and sought to inform non-laboratorians of the realities at every opportunity. Lack of comparable test results can lead to patient safety issues, including misdiagnoses and/or inappropriate treatment. Recently an international consortium has recognized the need for harmonization of all lab results and begun to work on the problem. Although this effort is just beginning and the road ahead is long until general test harmonization can occur, it is a road worth traveling.

 

???????????????????????????????????????????????????????????????????????????????????

-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.

Happy Holidays from Lab Medicine

It’s going to be a little quiet here over the next few weeks while our team of mad scientist writers enjoy time with their families. We’ll be back in action after the New Year with lots of great information for you. In the meantime, the editors of Lab Medicine would like to wish you and yours a happy and safe holiday season.

 

 

Pathologist and Pathologist-in-Training Engagement as Patient Advocates

I’m used to being surrounded by people who are passionate about transforming systems. I’ve spent many years involved in organizing grassroots movements, health advocacy, and health equity campaigns in the minority and immigrant communities. And the year before I started residency, I studied for a masters degree in public health where I focused on these same issues,  along with more scientific training in molecular and infectious disease epidemiology. But as a resident, I have had to make some tough choices.

Even though I am back in Chicago where I attended college and first got involved working with minority and immigrant health issues, my community organizing, for now, will take a back seat to my education and service duties. And even though I sometimes reminisce about and miss the electrifying momentum involved in pushing toward such social change, I know that once I’m finished my training that I can return to contributing to these movements again on a more personal level. So I’m fine with the decisions I’ve had to make. We all have to make choices about what is most important at that specific time in our lives.

And so as a resident, I’ve focused my thoughts and efforts on how to create a movement within pathology to question our role on the clinical patient care team and to engage those in our profession to respond to this question – reasons why I got more involved with ASCP and CAP. With the gradual implementation of portions of the ACA since 2008 that is now moving into a more palpable phase, pathologists, tech staff, and residents have an opportunity to show our worth to the health care team. We have the opportunity to show that we are the experts in data interpretation and that in terms of more complicated testing such as flow cytometry, cytogenetics, or molecular tests, that the pathologist would be the best person to order the most appropriate tests.

No one knows better that we do what are the costs, indications, and limits of specific tests and despite what non-pathologists may think, we were trained just as they were in how to work up a patient and differential diagnosis. So who better to choose the right test for the right patient at the right time? I know that pathologists have the reputation of being not the most vocal or interactive doctors so how do we engage not just our leaders but also pathologists in general to take more ownership of patient care decisions and to speak up? How do we train our next generation to also see this as the big picture?

In grassroots organizing, strategy requires an understanding of the power dynamics and forces involved in decision making within the system one wants to change. So what drives pathologists and pathologists-in-training and how do we light a fire within our profession not to waste this opportunity that has been provided by health care reform to redefine our role within the patient care team? How do we nurture true patient advocates? I’ve been a little frustrated with these thoughts lately so please leave a comment with suggestions on how you think that we can accomplish these goals.

 

Chung

Betty Chung, DO, MPH, MA is a second year resident physician at the University of Illinois Hospital and Health Sciences System in Chicago, IL.

Passport Nostalgia—Looking Back

One of my life mottos is, “Never let your passport expire.”I just renewed mine and when they sent back the old one, punched full of holes, it was interesting see all the passport stamps and colorful visa stickers, and reflect on places I’ve been in the past ten years.  I enjoyed revisiting a variety of unexpected journeys and the opportunity to relive some very special travel memories.

The pages are home to circles, squares, and odd shaped stamps in a variety of inks. I find hurried and smeared signatures, kanji graphicsand Aramaic scripts, and a variety of illegible initials; there is a whole page devoted to the amount of US dollars and Ugandan currency I was required to pay for an “on foot” border entry; there are colorful images and seals; the back has a host of barely legible security stickers in a rainbow of colors; there is even a page announcing an “amendment” to add more page.  Ten years of travel history bound in a single, 3.5 x 5 inch dark blue booklet, and it speaks about the world in a subtle stillness from the corner of my desk.

As I flip through the pages, I’m reminded that this little booklet has been with me for all my laboratory consulting journeys, and occasionally has had a mind of its own.  The Johannesburg airport incident for one; and next time I’ll tell you about passports and horses.  I don’t have a stamp in there for this little side trip in the mountains outside Bishkek, Kyrgystan, but I’m thinking I should have—you can be the judge.Take a moment and thumb through your passport.  I promise it will jog travel memories, and perhaps invite you to take another international journey soon.  The world is indeed a small place, and I intend to fill as many pages as possible in the next ten years!

 

???????????????????????????????

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

Inborn Errors of Metabolism in Adults

In general when people think of a genetic defect or an inborn error of metabolism (IEM), they think in terms of disorders that are diagnosed and treated in infancy or early childhood. Interestingly, the more we learn about IEM, the more we see that IEM can be diagnosed at nearly any age. Milder forms of the disorders may present in later years, anywhere from adolescence through adulthood.

Classical presentations of IEM are generally due to total or near total enzyme deficiencies that result in life-threatening medical crises, or major developmental delay and mental retardation. Adults or near adults who present with a range of milder symptoms may be misdiagnosed or nor diagnosed at all.

A few examples of IEM that may have later and milder presentations include:

1)  Ornithine transcarbamylase (OTC ) deficiency, the most common urea cycle defect which is often fatal in newborn male infants, can and does present in the teenage years as altered mental status, when a protein load cannot be handled and ammonia levels rise and impact brain function.

2)  Carnitine palmitoyltransferase 2 (CPT2) deficiency, a disorder of fatty acid metabolism, presents with cardiomyopathy and liver failure in the newborn period. It can also present with muscle weakness, myopathy and rhabdomyolysis in the teenage or young adult years when the teenager tries out for a sports team and the muscle cannot metabolize adequate fats.

3)  3-methylcrotonyl-CoA carboxylase (3MCC) deficiency, a disorder of leucine metabolism, may present in infants or toddlers as feeding difficulties, neurological symptoms including seizures, and can cause death. 3MCC can also present in a completely asymptomatic mother whose infant is picked up on newborn screening because of the Mom’s abnormal metabolites in the infant’s blood.

In most of these cases the deficiency is mild enough that the individual is self-regulating, avoiding foods or activities that make them feel bad. In addition, the IEM may not manifest unless some other confounding factor precipitates it, such as stress, illness, or fasting. The important thing to remember though, is that altered mental status in a teenager does not always represent alcohol, drug or other mood altering substances. IEM can be diagnosed at any age and should always be considered as part of the differential diagnosis.

 

???????????????????????????????????????????????????????????????????????????????????

-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.

Are Antibacterial Soaps Effective?

The FDA is asking manufacturers to prove the effectiveness of their antibacterial products that use triclosan or triclocarban as the active ingredient. (See the press release here.) This comes on the heels of last week’s announcement of their plan to help phase out the use of medically important antibiotics in food animals.

When I became a microbiologist I stopped using products with triclosan in an effort to curb antibiotic resistance. While I like to see the FDA’s efforts, I wonder if they’re doing too little, too late, and I’m not the only one.

Some additional reading on the topic:

1. Mechanism of triclosan resistance study, published 1999.

2. Another triclosan resistance study, published 2006.

Edited to add: Maryn McKenna’s excellent write-up on the topic.

Swails

-Kelly Swails is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.