W. Harry Hannon, PhD
Chief, Newborn Screening Branch
Division of Laboratory Sciences
Centers for Disease Control and Prevention (CDC)

Tell me a bit about your background and specifically how you became interested in newborn screening.

I started working at CDC after graduating from high school in 1961. My first job was handling sewage specimens that came in for polio surveillance studies in the 1960s. I rung out into aliquots of antibiotic fluid sponges that had been lowered into the sewage systems in cities. I also analyzed stool specimens from babies for enteroviruses. I received a BS degree in Chemistry from Georgia State University (1965). I left CDC a couple of years after receiving the BS degree to pursue a PhD from the University of Tennessee (1972). I did postdoctoral training at Oak Ridge National Laboratories (1972-1974). Then, I returned to CDC to work. I’ve been working at CDC ever since—39 years of service. When I came back to CDC, I had done research on isotopic assays for tumor-specific transplantation antigens during my postdoctoral training, so I was asked to set up immunoassays for thyroid hormones—thyroxine and thyrotropin. I was working on ways to standardize and improve these assays in the clinical laboratory. At that time, a test was developed for detecting congenital hypothyroidism. Most state laboratories were not familiar with radioisotopic immunoassays (RIA) that were used to perform the test. I created a program to help state laboratories set up and operate RIAs for detection of congenital hypothyroidism with dried-blood spot samples, as well as provided quality control and quality assurance consultation and assessment tools for these laboratories.

What is your current position?

Presently, I am Chief of the Newborn Screening Branch at CDC. My day consists of numerous activities, from dealing with laboratory science issues to attending management meetings and handling personnel issues. I deal with all aspects of running a busy laboratory involved in research with a heavy service component, which provides service and handles issues that arise around the world.

In 1978, you created the Newborn Screening Quality Assurance Program at CDC, which now provides services to all US newborn screening laboratories and to over 400 laboratories in 54 countries for more than 35 disorders. Can you elaborate on the program and how it has evolved over the years?

This is the 30th year of the Newborn Screening Quality Assurance Program. It started with a few laboratories performing tests to detect congenital hypothyroidism. From that seed grew the present Newborn Screening Quality Assurance Program. When a new disorder came along, it was evaluated and determined whether it was appropriate to add to our program. Our staff at CDC grew from a few people to presently about 45 people in the newly formed Newborn Screening and Molecular Biology Branch, Division of Laboratory Sciences.

The idea behind the program was to harmonize newborn screening testing. By harmonize, I mean you can perform the test in a lot of different ways, but you must always get the same high quality answer. When newborn screening started, it was just a small public health niche. In the late 1990s, tandem mass spectrometry technology was introduced. All at once, there was a multianalyte system that tested for a large number of new disorders. Tandem mass spectrometry started in a small private laboratory, but it has expanded to a large number of public health laboratories. The Internet came along and more parent groups got involved in advocating for newborn screening. Parents, who were faced with disorders that affected their children, pushed for the disorders to be added to newborn screening test panels. They became involved with parent groups and organized a focused effort to interact with congressmen, talk with editors of publications, and develop Internet websites to provide support and push for the testing of particular disorders. Newborn screening has become a passionate topic for most parents and childbearing women.

The ultimate issue is to protect those babies for which there is a known intervention and improved outcome from early detection of the disorder. As it becomes known that there is an intervention that alters the outcome of the newborn, those disorders are strongly considered for addition to the screening panels. For example, Jim Kelly had a son with Krabbe Leukodystrophy. He started Hunter’s Hope foundation in New York. He was active with politicians to fight for legislation that would increase screening for potentially fatal diseases in newborns. Groups and parents, such as Jim Kelly, became well informed. This advocacy led to the recent introduction of testing for Krabbe by New York’s Newborn Screening Program. Now, CDC is not only involved with monitoring the performance of existing newborn screening tests, but it also develops the quality assurance materials for start-up tests to help ensure the highest quality of pilot testing.

Tell me about the work you do as a globally recognized proponent for the enhancement of newborn screening programs.

I have written standards for the World Health Organization (WHO) for designing and implementing congenital hypothyroid and phenylketonuria (PKU) screening in developing and developed countries. I have also provided on-site assistance and consultations for the enhancement of newborn screening programs in Thailand, China, and the Philippines, and I have been invited to speak at numerous national and international newborn screening symposia.

You are actively involved as Vice President of the International Society for Neonatal Screening (ISNS), among other professional societies. Can you describe a bit about your involvement in ISNS?

ISNS develops guidelines and reference materials for newborn screening; coordinates worldwide meetings, symposia, discussions, reports, and publications regarding neonatal screening; contributes to development and teaching; and works to harmonize screening programs and methods. The society also recognizes worldwide outstanding newborn screening professionals with an annual Robert Guthrie Award. This year, ISNS will recognize a young scientist with an award for outstanding new contributor to newborn screening. ISNS is also working toward starting a North American chapter. 

What key issues are faced in the development of programs for global uniformity in newborn screening?

The key issue is economics—it is the driving force. Many countries do not have the money to put into the infrastructure for newborn screening. Of all the problems the country faces, newborn screening is not always the top priority. Most of the newborn screening operations in other countries are for congenital hypothyroidism and PKU. Another issue faced is that people in developing countries do not always have access to equivalent services. If the test can be done but the infant cannot be found to apply the intervention and treatment, it is a wasted effort. The infrastructure must be in place to do the testing and follow-up, and the country must have access to the drugs and special foods to treat the infant. Congenital hypothyroidism is used as the primary disorder to initiate testing as a foundation for building infrastructure. With the infrastructure in place for hypothyroidism, the testing can be expanded to detect additional disorders. 

What motivates you to devote your time to educating people around the world about newborn screening?

My motivation is the passion to see all babies served and their lives enhanced. I feel newborn screening programs are an outstanding effort to improve the quality of life for many newborns worldwide.

What initiated your involvement in CLSI?

My involvement in CLSI started before newborn screening. I was involved with AACC, which was in partnership with CLSI. I was at a meeting early after graduate school about standardization of thyroxine serum assays. AACC had committees, including CLSI members, that were analyte focused. I got involved in working on standards. Most of the standards at that time were serum-based standards, not paper standards. In 1980, past CLSI Executive Vice President John Bergen, and past CLSI Vice President, Standards, John Zlockie came to my office at CDC and asked me to get involved in a standard for blood spot collection for newborn screening. CDC was heavily involved in CLSI standards development. There is a strong connection between CDC and CLSI, especially in my division, which was Clinical Chemistry at the time. My first project was Blood Collection on Filter Paper for Newborn Screening (LA04).

What has sustained your interest?

The need to see documents developed and improved services as a result of those documents has sustained my interest in the development of standards. I wanted to contribute to what standards were developed and have my voice heard. 

How have you benefited by becoming a CLSI volunteer?

My organization and my supervisor strongly support CLSI. I have had the opportunity to meet a lot of professionals in many areas of expertise, and I have extensively expanded my network of scientists in newborn screening and clinical chemistry.

In January 2008, CLSI released an updated newborn screening DVD, Making a Difference Through Newborn Screening: Blood Collection on Filter Paper (LA04-A5-DVD). In what ways will newborn screening professionals benefit from using the DVD, along with the complementary document LA04-A5, and Newborn Screening Quick Guides?

The intent of the DVD is to make it available to blood collection centers for newborn screening, so they get a visual representation of how to collect quality blood spots, and understand why high quality spots are needed and what low quality spots look like. Hopefully, it spins off to other areas where blood collected on filter paper is used. The idea of the DVD resource is that it can be  used on a computer at the hospital, and the phlebotomists who are training could easily look at it and learn. Many people learn better by seeing something in action than reading about it. Most nurses and phlebotomists have tight time schedules to do their jobs. VHS required more equipment for the work center and the training aspect. Now with the DVD, we have a better and user-friendly guide for impacting positive quality in newborn screening specimen collection. 

You have authored over 200 publications, served on numerous symposia organization committees, provided consultations, and received many awards for your contributions to newborn screening worldwide. Do you find it important to reference CLSI documents in your work?

LA04 has been referenced at just about every one of my presentations since it was published. I carry it with me to every country I visit. I had a woman in my office today who works for Turkish newborn screening laboratories, and she left here today with a copy of LA04 and Newborn Screening Follow-up (I/LA27). I continuously emphasize the importance of all of the CLSI standards. Just the other day, a question came up about proficiency testing, and I went to the CLSI library to find a document that would help. I continue to lean on CLSI if there is a need for standardization or guidelines. If an issue comes up and I don’t know of a CLSI document that can handle it, I usually try to get someone at CLSI to consider development of a document. I am always looking for opportunities for CLSI projects.

What, in your opinion, is the biggest challenge in consensus document development?

The biggest challenge is to get participants to understand that we are writing a user-friendly “cookbook,” which has all the important information and all of the pitfalls and corrective actions to ensure quality performance. It is a learning experience to find a balance of including enough information to educate the user on the essential information required for quality performance, and not write a textbook.

What do you feel is CLSI’s role in the education and global standardization of newborn screening?

For many years, newborn screening was a small niche—only 30 to 40 laboratories performed the tests. LA04 has a much broader audience base, since most hospitals and many physician offices do blood collection. The domestic market does not grow much, since the impact of 4 million plus babies is the same and the number of customers and potential purchasers is small when few laboratories do newborn screening; however, the addition of new technologies and disorders creates new needs. Also, as more countries start to expand newborn screening, the audience will grow larger. But, developing countries may not be able to afford to pay the cost. Some organizations in the United States purchase copies from CLSI at a bulk discount to distribute to laboratories around the world.

Do you see any prevalent topics, future issues, or market needs that would require the development of additional CLSI standards and guidelines in the area of newborn screening? 

Two new projects are being developed from needs identified in the newborn screening area—Newborn Screening Guidelines for Premature and Sick Newborns and Newborn Screening by Tandem Mass Spectrometry. I envision the project for Newborn Screening by Tandem Mass Spectrometry growing into a series of method-specific guidance documents including disorder-specific testing, specific molecular methods, and multianalyte platforms for immunoassay systems.

Do you have suggestions for what you would like to see occur with CLSI, either in the area of newborn screening, or the organization in general?

I would like to see CLSI continue to get more global recognition and awareness for its standards. By continuing to encourage a strong active global participation in standards development, CLSI documents will have a greater global impact. I would also like to see CLSI continue its partnership with the International Organization for Standardization (ISO) in order to have the standards recognized in the global community. To my knowledge, no one has written an ISO document on blood collection. In the newborn screening community, my goal is to make sure everyone understands what CLSI is and how it contributes to the improvement of newborn screening. Another recommendation is for CLSI to move toward translating documents in multiple languages. There are large markets in South America and Central America. In addition, there are many Hispanic nurses and phlebotomists in the United States who might prefer reading the CLSI documents in Spanish. A final recommendation is for CLSI to get more young scientists involved in document development. CLSI could entice involvement by having volunteers, who have been involved in CLSI for a long time and have a strong appreciation for the impact of CLSI standards on the community, to encourage and recommend young scientists and others to participate. With a strong mentoring group, young scientists will get involved in CLSI, and will take a strong organization and sustain it across generations.  

“Volunteer Focus” is an eNews feature that focuses on Clinical and Laboratory Standards Institute (CLSI) volunteers from different areas of the health care community, and the contributions they make to the patient-testing world through CLSI and their daily work. To recommend a volunteer to be featured in an upcoming issue, e-mail customerservice@clsi.org.
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