2004 Outstanding Contributions through Service to the Profession of Clinical Chemistry
Karen L. Nickel, PhD, has been actively involved as a clinical chemist since 1972. Her early interest in clinical endocrinology and healthcare required her to obtain the education and credentials necessary to participate in this exciting field. She earned her BS degree in chemistry from Oregon State University and her MS and PhD in biochemistry and analytical chemistry with special emphasis on endocrinology from Kansas State University. After 4 years of teaching at the university level, Dr. Nickel took postdoctoral training in clinical chemistry to qualify for licensure in California as a Clinical Chemist Scientist. After completing this in 1972, she was certified as a Clinical Chemist by the National Registry of Clinical Chemistry in 1975, achieved Diplomat status with the American Board of Clinical Chemistry in 1978, and was licensed as Clinical Chemist, Laboratory Director by the California Department of Health in 1978.
Dr. Nickel has held several responsible positions as a clinical chemist, starting in the newly emerging field of RIA developing assays and managing a Reference Laboratory in Newbury Park. From there she went to BioScience Laboratories in Van Nuys, where she was Director of Steroid Endocrinology, and later to the Endocrine Metabolic Center in Oakland, where she was Laboratory Director. During this time she was involved in the Southern California and Northern California sections of the AACC, serving as chairperson and education coordinator of the Southern California section. At the AACC national level, Dr. Nickel served as ACCENT chairperson for that new program and as Councilor on the Council Steering Committee and Finance Committees. In 1982, she was elected to the Board of Directors of the AACC. That same year, she was chair of the scientific sessions for the AACC meeting in Anaheim. In 1986, Dr. Nickel was elected national Secretary of the AACC and re-instated the AACC newsletter, of which she was editor. In 1989, Dr. Nickel was elected as President-Elect of the AACC and served as President in 1991.
Dr. Nickel’s career took an interesting turn in 1993 when she accepted the position as Chief of Laboratory Field Services for the California Department of Health Services. Never before had a person from “the outside” filled this position, or a woman; this was therefore the challenge of a lifetime. This program oversees 17,500 laboratories in California and 27,000 licensed clinical laboratory personnel. The first order of business was to learn state and federal laboratory laws, inside and out, to provide consultation on laboratory issues. The second order of business was to help prepare California for a CLIA exemption. This process involved a major law change, new regulations, program analyses, and documentation to the federal government. Finally, in 1999, California was awarded CLIA exemption, but this was subsequently declined because of the overhead fees assessed. Her third order of business at the Department of Health was to establish a career ladder for laboratory personnel. In California, the career ladder had been three-runged since the 1950s: unlicensed laboratory aides, BS-level scientists, and PhD/MD-level directors. Not recognized were phlebotomists, laboratory technicians, genetic scientists, Master’s level supervisors, or nontraditional directors. Taking advantage of the resources of the Department’s advisory committee, Dr. Nickel has been involved in development of many licensing regulations to establish licensing and examination standards for laboratory personnel. California now recognizes licenses of approximately a dozen categories of baccalaureate- and doctorate-level persons, as well as high school-level phlebotomists and associate-level technicians.
Another accomplishment with the Department of Health has been Dr. Nickel’s work fighting laboratory fraud and taking enforcement action for violations of laboratory law. A new law enacted in 2000, much from Dr. Nickel’s input, and the regulations that followed have made enforcement of California law much clearer and easier to carry out. This has led to the closure of ~100 laboratories involved with billing fraud and in the creation of a hot list that denies new licenses to laboratories or their officials found guilty of billing irregularities.
Dr. Nickel remembers where it all began and has continued her laboratory involvement since working for the Department of Health. She is highly sought after as a speaker, speaking ~30 times a year on laboratory matters to professional organizations, hospitals, and seminars. She uses input from these meetings to guide the direction of her program and to seek advice on laboratory matters. Dr. Nickel hopes to continue working, at least part time, for many years, developing regulations and providing counsel to the Department on laboratory matters.
1991 AACC Past President’s Award
Dr. Nickel served as AACC president in 1991.