American Association for Clinical Chemistry
Better health through laboratory medicine
March 2009 Clinical Laboratory News: Certifying Excellence

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March 2009: Volume 35, Number 3

Certifying Excellence
How Board Exams Position Laboratorians on the Cutting Edge
By Bill Malone

With an economy in critical condition and the specter of broad healthcare reform on the horizon, board certification in lab medicine is poised to become even more vital to the field as the bedrock of lab professionals’ medical credibility and value. In recent years, lab professionals have outgrown the role assigned to the classical clinical chemist, and now contribute their distinctive expertise in areas such as molecular biology, pharmacogenetics, and biomarker discovery. In fact, three laboratorians now have achieved certification in all three specialties offered by the American Board of Clinical Chemistry—clinical chemistry, toxicological chemistry, and molecular diagnostics—a symbol of the increasing reach of laboratorians into emerging areas of medicine.

Board certification has allowed PhD-level laboratorians to be integrated into clinical medicine and helped open doors that might otherwise only be available to physicians, said John G. Howe, PhD, DABCC, FACB, president of ABCC, and assistant professor and director of Yale’s molecular diagnostics laboratory. “There aren’t many areas in medicine where you see PhDs operating at a clinical level, and clinical chemistry is one of the most successful disciplines for that. PhDs could not have achieved that level unless there was a certification process that showed they had gone through a rigorous program and examination.” For a look at a breakdown of ABCC board certification, click here.

An Evolving Field

Besides being one of the few areas where PhDs work in a clinical setting, laboratorians also enjoy a unique position as innovators close to the cutting edge of science, where new research is translated into biomarkers for diagnostic tests, companions to drug development, or highly sophisticated instruments. And with forecasts for an epidemic of retiring laboratorians in the coming decades, the field promises to maintain demand for highly trained, board-certified professionals who can fill the special role laboratorians have made for themselves, said Ann Gronowski, PhD, DABCC, FACB, who trains post-doctoral fellows at Washington University in St. Louis School of Medicine. Gronowski is also associate professor of pathology and immunology, and associate medical director for clinical chemistry. “Certainly one could argue that as people retire, there’s going to be some extent of downsizing and consolidating, but there’s still a great opportunity for jobs. There are a lot of opportunities for laboratorians to be involved in: developing tests, determining their clinical utility, and educating physicians about how and when to use them.”

Gronowski compares the field to that of pharmacy, where people have said for a long time that since pharmacists merely count pills, maybe there isn’t a need for so many pharmacists. “To some extent, there has been some downsizing in the pharmacy, but there is no way that physicians can know all there is to know about all the different drugs out there,” said Gronowski. “It’s the same with lab tests; there’s no way that physicians can be familiar with all of them, especially as we get so many new tests on the market every year. The lab will change, but that doesn’t mean that there’s less of a need for highly qualified people who know how to develop, interpret, and properly utilize lab tests.”

As the field continues to change, board certification is a way to add value to yourself and open doors for a richer career, according to Gronowski. “ABCC is seeing more multi-boarded people, and that just broadens the areas of the laboratory that you’re able to cover. We all fill our own niches, but it makes you more broadly applicable and more valuable to the hospital or other institution you’re in.”

Maintaining Excellence

Keeping up with the pace of change in the field poses the toughest challenge to licensing boards. Howe pointed to ABCC’s creation of the molecular diagnostics exam in 2000. The board saw how clinical chemists were moving more and more into molecular diagnostics and wanted to stay ahead of the curve. ABCC designed the molecular diagnostics exam to cover the full breadth of the field, from genetics to hematopathology and microbiology. “Into the future, we have to be nimble enough to advocate the need for this certification and then be able to keep it up to date. I think ABCC is interesting as one of the few organizations certifying PhDs in medical care, and I feel there is a significant requirement on our part to keep it as high quality as possible and maintain it as the gold standard in our field,” said Howe.

The main way the board wrestles with changing science is crafting new questions for the exams. Formally, ABCC reviews each exam and incorporates new questions on an annual basis, but it’s really a more organic process, said Howe. ABCC exam committees pull in people who have expertise in each area of the exam, and the board works on how to write and include state-of-the-art methods on a continuous basis. Currently, the board is tackling pharmacogenetics, working to determine how it should fit into each of the three exams.

But adding new questions is easier said than done. It’s a tricky and painful undertaking when the board knows the exams can’t grow indefinitely in length, but that there are new methods that need to be dealt with. “We really struggle with that, because as the knowledge base expands and laboratorians have to know more, how can you incorporate that into the same number of questions? It’s very difficult,” said Loralie Langman, PhD, DABCC, FACB, assistant professor and director of Mayo Clinic’s toxicology and drug monitoring laboratory.

On the flipside, the board also deals with not only what to add but also what to keep in the exams. Often students forget that they may encounter a question about an analytical method that’s not frequently used anymore, but there’s a purpose in keeping these questions, said Langman. “I think it’s important to remember where we came from, to understand how the chemistries and assays developed chronologically into what we have now. Moreover, some smaller labs don’t have access to the high-tech equipment students are familiar with, so there are a lot of labs out there still using more traditional methods.”

To ensure diplomates stay on the cutting edge, board-certified laboratorians also make a commitment to continuing education. Diplomates must document 50 contact hours of continuing education (CE) credit every 2 years in order to maintain listing in the directory of active diplomates. “I think just because you’ve passed the exam once doesn’t prove you still have that medical knowledge from now until the end of time,” said Langman. “This is why continuing education is so critical.”

Building a Career

For students in post-doctoral programs around the country, board certification marks an end to one phase of their careers and the start of another. Deciding which exam to take and when really boils down to what you want to do with your career, said Langman, who also trains post-docs, and is one of three to hold ABCC certification in all three specialties (See Box, below). “I wouldn’t recommend taking all three exams to everyone. I tell students in the post-doctoral training program, get clinical chemistry first, find your niche, or find what you love, and if it happens to be one of those other disciplines, then it’s up to you.” In fact, most ComACC programs expect their trainees to take the ABCC Clinical Chemistry board exam, and they don’t accept applicants if they don’t have the required coursework to sit for the exam.

Three Unique Careers

These three laboratorians have achieved ABCC certification in all three specialties.

Abdel-Baset Halim, PharmD, PhD, DABCC, FACB
Director, Clinical Biomarker Development, Daiichi-Sankyo
“Even though I work at a pharmaceutical company, people here recognize my board certifications in lab medicine and feel confident that they have a knowledgeable person on board who can develop and validate assays and develop biomarkers for drug discovery. It is a good investment for the company, because drug discovery requires expertise in all three of these areas. They can save money hiring one person instead of three.” 

Loralie Langman, PhD, DABCC, FACB, DABFT

Director, Toxicology and Drug Monitoring Lab, Mayo Clinic
“Personally, I decided to go for all three certifications because I like to challenge myself. I’m a forensic toxicologist who’s interested in pharmacogenetics, so it made sense for the advancement of my career. This has also given me a unique position where I can help contribute to improving each of those exams as a member of the ABCC board.”

Robert White, PhD, DABCC, CHRM

Scientific Director and Laboratory Director, Clinical Chemistry and Toxicology, DSI-LabCorp
“As the director of a forensic toxicology laboratory, I do a fair amount of courtroom testimony. If you’re going to be declared an expert in a courtroom, board certification is just about essential. All three of the certifications really do have application to my everyday practice—it’s not just something neat to add to my name.”

Taking a board exam is about more than deciding where you want to work, though. It’s a critical step that gives laboratorians not only the cachet of adding a designation to their name, but also a level of credibility that engenders acceptance and respect by their colleagues in medicine. “It’s a significant benefit to make someone legitimate who only has a PhD in the eyes of MDs who have gone through four years of medical school, a residency, and have been tested all along the way. I noticed this myself that when I got the certification—I immediately found more doors opened to me than before,” said Howe. “You can state that you’re at the cutting edge of the field and know the state-of-the-art and that projects out to your community.”

For Abdel-Baset Halim, PharmD, PhD, DABCC, FACB, board certification in each specialty from ABCC led to an unusual position at the pharmaceutical company Daiichi-Sankyo (See Box, above). Prior to his current position, Halim worked for an academic medical lab, a private lab, and a biotech company. Key to landing the job at Daiichi-Sankyo was the company’s recognition of both Halim’s own knowledge and certifications, as well as their need for expertise in lab medicine. “For a pharmaceutical company, it’s really an emerging idea for them to have a person with skills in clinical chemistry, toxicological chemistry, or molecular biology. It makes them feel confident in what we are doing in the lab,” he said. Before Halim joined the company, each study group maintained responsibility for its own biomarkers, and they often struggled to sort out discrepancies with results, and couldn’t compare lab-to-lab or study-to-study, explained Halim. “Now they are more confident and relieved to know that there is someone here that can oversee the quality of the laboratory data.”

Meeting State and Federal Requirements

Many laboratorians seek board certification primarily to meet CLIA requirements for being a laboratory director. At the same time, a growing number of states have added another layer of requirements on labs, both for PhD lab directors and for clinical laboratory scientists. California, often a forerunner of legislation at the state level, has strict requirements for state licensure. The state requires a doctoral degree, 4 years of post-doctoral work—2 of which have to be supervisory—and in addition to board certification, a written and oral exam on state law. “With state licensure, you have an obligation to understand and comply with state law,” said Karen Nickel, PhD, DABCC, FACB, director of Laboratory Field Services (LFS) in the California State Department of Public Health. “Our law has a significant number of issues that aren’t in CLIA, so if you’re a lab director and you don’t know the law, how are you going to show compliance? Having a state license is a way of enforcing compliance.” Nickel noted that without licensure, the only recourse the state has if someone isn’t following state laws is to seek criminal action, which her department can’t do.

While the purpose of state licensure is to raise the bar for the profession and provide the state a way to enforce its laws, some of the licensure requirements can be a barrier. California has education requirements, including courses in physics and medical microbiology, that not all board-certified clinical lab scientists have completed. Often, laboratorians looking to relocate to California become frustrated that they need to go back to school and take a course that isn’t as important to their job as it was 50 years ago when the law was written, explained Nickel. LFS is working to change the law on some of these requirements, but in the mean time, laboratorians must meet all the education requirements as spelled out in the law. “We are working to change this, but it’s not going to happen overnight. Many are frustrated to the max that they have to go back and take a course in physics, and I’m sorry for them, but for now, you just have to do it,” said Nickel.

At the clinical laboratory scientist level (CLS), California recently changed the law to allow the state to get out of the exam business and approve exams for licensing from other organizations, such as ABCC. At the end of last year, the state approved part B of the ABCC clinical chemistry exam for doctorate-level clinical chemist licensure, a specialty under the CLS rubric. A CLS generalist licensure requires a baccalaureate degree and 1 year post-baccalaureate training. Now that people don’t have to travel to California to sit for the licensing exam, Nickel said the state is seeing many more out-of-state applicants. LFS now receives 60 to 80 applications a month, versus about 125 a year from outside California in the past. “We’re seeing more states that are licensing their lab people now. The unions are very interested in this, they see it as job protection and they’re very supportive of it, and the labs like it too because it gives them a stamp of quality when they have an applicant come in who’s met all the education, training, and examination requirements. It gives them the idea this is a good qualified person that they can hire.”

CLIA-Approved Certification Boards

Eight certification boards are approved for clinical consultants and directors of high-complexity labs.

ABB—American Board of Bioanalysis

ABCC—American Board of Clinical Chemistry
    ABCC 24-month ComACC accredited program

ABFT—American Board of Forensic Toxicology

ABHI—American Board of Histocompatability and Immunogenetics

ABMG—American Board of Medical Genetics

ABMLI—American Board of Medical Laboratory Immunology

ABMM—American Board of Medical Microbiology

NRCC—National Registry of Certified Chemists

A High Standard

Although not part of the exam, board certification also involves an ethical component, an area of increasing concern to corporate and medical organizations. “Ethics of course is very important since ABCC diplomates generally are in the business of overseeing clinical lab testing, which can have life-threatening consequences if done improperly,” said Howe. He indicated that laboratorians’ ethical and moral character are monitored continuously from various angles throughout their career. “Once you are at the point of applying for ABCC certification, you have already been through a PhD program, and perhaps a postdoctoral program and/or clinical work experience. Each of these experiences is overseen by someone who can write a letter for you to support a move to the next career level as well a letter for supporting an ABCC certification. The letters are generally the primary way a person's ethical and moral character are conveyed to a certifying organization, and ABCC is no different.” Applicants for ABCC certification must provide three letters of reference attesting to their moral character, and its bylaws set out procedures for denying, suspending, or revoking certification in the case of unethical conduct.

Ethics are an issue in many professions today, and AACC’s Board of Directors took steps in 2007 to update the organization’s ethics policy, adding guidelines about disclosure of conflicts of interest. While ABCC is a separately incorporated organization with its own independent board, the two organizations maintain close ties through members and diplomates that are active in both organizations. “We stress ethics at AACC and at Washington University, and I think it should be stressed everywhere. I think that’s another plug for getting board certified—it means that someone has vouched for your ethical standards, and that’s one more positive in your favor,” said Gronowski. “Although clinical chemists don’t treat patients, we do see laboratory results. Sometimes we’re in a position to detect medical errors that happen, intentionally or unintentionally. We have a duty to act ethically when faced with such situations.”