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

Beyond the Lab

If you can’t make it to ASCP’s Annual Meeting this year, experience it vicariously through Lab Medicine. We’ll listen to the Honorable Hillary Rodham Clinton’s keynote speech, attend seminars, hang out at Science Connection Central—and report everything to you. Watch this space next week–September 18-21–to keep on top of what’s happening at the meeting in Chicago.

Tough Conversations

Leadership involves all the difficult situations that most people tend to avoid. However, as leaders it is our responsibility to take those difficult situations and turn them into constructive encounters. No one enjoys telling an employee that their performance is subpar but there are productive ways to have  this discussion. A Performance Improvement Plan (PIP) is one of the tools I use to identify the specific areas that an employee is struggling, identify the tools they need to improve, and give them a timeline to achieve success. It’s important note that these discussions do not have to be technical in nature. PIP’s are also used for behavioral issues such as conduct detrimental to work environment.

A Performance Improvement Plan (PIP) is one of the tools I use to identify the specific areas that an employee is struggling, identify the tools they need to improve, and give them a timeline to achieve success.

I begin by identifying the job tasks that are not being performed at the expected level of competency. The key here is identifying specific job tasks that the employee can work on. For example, let’s say when John Doe works in Hematology, stat turnaround times aren’t met. When meeting with John, don’t say something like “you need to be better at hematology.” Instead, say “I need you to work on completing stat samples within the turnaround time. How can we make that happen?” Listing generalized deficiencies doesn’t give the employee a real sense of what they need to work on.

Second, clearly identify the expected improvement that the employee needs to achieve. Using our example above, we would tell John that we expect stat turnaround times for CBCs with differentials need to be less than 60 minutes when he is working in Hematology.

The last step is to determine a fair time frame to give the employee a fair chance to succeed. For our example we may monitor John’s stat CBC turnaround times for 30 days. At the end the PIP is evaluated to determine  whether or not the employee has met their stated plan. If the answer is no, you need to have a serious discussion with the employee. You may find yourself asking him if he might be successful outside of your laboratory. As leaders we must be willing to have those tough conversations. In the long run, however, a 30 day performance improvement plan is much more efficient than three to six months of training a new employee.

-Matthew Herasuta

Neophyte Pathology Resident Musings on the Impact that Staff Can Make

As a pathology resident that is just barely into the start of my second year, I’m often amazed at how my perspectives about the profession, the training, and my role within this system have changed. My program has four hospitals through which we rotate: an urban academic center, a VA hospital, and two community hospitals. During PGY-1, the six of us residents remained entirely at the academic center with one month of hematopathology at the VA. For the first three months, we were on an “intro to surgical pathology” rotation together before we were separated to various clinical or anatomic pathology rotations.

No program is perfect, but one of the assets of the surgical pathology department at our main academic center was the active hands-on effort our pathology assistants and fellows made to help us learn to gross and manage our time. Our attending physicians, if asked, also would come to the gross room to explain how and why we should gross their specimens in a specific manner. They were also very open to feedback and incorporated our comments into refining the two week orientation “boot camp” that is given every year to new PGY-1’s. Without being overbearing, they allowed us to progress at our own pace and constantly nudged us to improve in areas where we were weak, because as a PGY-2’s at the VA and community hospitals, we would be on our own. I would hear them say this over and over but didn’t really internalize the true impact of their words until the end of my first year.

During PGY-1, I was able to attend multiple conferences where I met other residents who told me about how surgical pathology was taught at their institutions. Of course, I had appreciated and recognized the extra time our PAs, fellows, and attendings had put into our learning then but now a year later, I truly understand how lucky I was to have them because not all residents were as fortunate. The interactions that staff has with residents can have a lasting impression on what type of pathologists we become, so I’d like to start my inaugural blog with a simple “thank you.”

-Betty Chung

A Brief History of Global Health—“Rats, Lice and History” in Action!

Wandering the planet in search of diseases to cure is not a new concept. Global Health certainly is a focus for the 21st Century, whether or not you are a movie star, a superhero, or Bill Gates! Most of us remember anecdotal history stories about “Dr. Livingstone, I presume.” Dr. Livingstone bush-whacked his way through Africa and encountered several tropical diseases as well as what we now know as malaria. With the onset of internet, frequent travel, and advanced international public health issues we find global health to be a connecting factor affecting the well-being and progress of all nations today. Volunteering in this area is a major way to help meet the increasing demands for worldwide health improvement.

So how did we get here? About 25 years ago, Rotary International began what is now a worldwide crusade to eradicate polio from the globe. The World Health Organization outlined the program and partnered with Rotary to provide the volunteer man/woman-power. “Polio Plus” took its place among the most effective international health campaigns of our time. With the help of other foundations and contributions (Gates Foundation matching grants, for example) we are close to ending this devastating disease. This campaign paved the path to the Global Health Initiative of2009, establishing the President’s Emergency Plan for Aids Relief. Commonly known as “PEPFAR”, this funding is dedicated to the global focus on HIV/AIDS treatment and prevention. PEPFAR funding oversight has been the responsibility of several governmental organizations including the CDC, and they partner with non-governmental and professional organizations to implement global health initiatives. This of course is a very high level summary; it should be noted that several other public and private international health funding streams exist in addition to PEPFAR.

Along with several other laboratory professional partnering organizations, ASCP has been working with the CDC for many years on improving and strengthening laboratory capacity in many PEPFAR funded countries around the globe. Projects include phlebotomy training, quality management, operational expertise, curriculum development for university training programs, and just about everything in between. One of the best ways to connect and build rapport with our international colleagues is by comparing and contrasting standard operating procedures, supply chain processes, teaching and training methods, and process improvement projects. I have had the good fortune to participate in all of these laboratory improvement initiatives. I learn something new every time I participate.

Laboratory professionals know that without a quality laboratory, healthcare is compromised. The Mayo School of Health Sciences reports that 60-70% % of healthcare decisions requires laboratory diagnostics (and it’s even higher in pediatrics). What better way to make the world a better place than to improve and strengthen the quality, safety, and operational effectiveness of our laboratories worldwide? On a personal level, it’s a way to give back to the profession that has enriched my life and given me so much over the years.

Global and international health affects all of us, and this century will be one of global initiatives and improvements worldwide. We can all make a difference locally, regionally, internationally. No matter where your focus and heart for laboratory improvement lies, you can make a difference. We’re all a part of the world’s big and interconnected laboratory! I’ll look forward to hearing about YOUR interest and involvement one day. Next time let’s explore some of the passions and pitfalls of being an international volunteer.

If you’re ever in Windhoek, Namibia during the last part of the rainy season, be sure to try the big white and meaty omajova (Oshiwambo for mushrooms…). They are the size of flying saucers, (no exaggeration!) and really, really good fixed just about any way you can imagine! If you’d like to see a picture of them and maybe a recipe from my favorite German chef in Windhoek feel free to email 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