D. Joe Boone, PhD      
Acting Director
Division of Laboratory Systems
National Center for Preparedness, Detection and Control of Infectious Diseases
Centers for Disease Control and Prevention (CDC)

You have been with the CDC for over 30 years. Can you briefly describe the work you have done there?

I came to the CDC to develop and run the proficiency testing programs for Clinical Chemistry and Toxicology under Clinical Laboratory Improvement Amendments (CLIA) ’67, which preceded CLIA ’88. In that job, I helped to develop programs for therapeutic drug monitoring, blood lead, enzymes, prenatal screening, and drugs of abuse. In 1986, when this program was transferred to the Health Care Financing Administration, my job became more of an advisor position on the technical aspects of the CLIA program, the Substance Abuse and Mental Health Services Administration's Drug Abuse Screening Program, and the Occupational Health and Safety Administration (OSHA) program for blood lead. I tried to help them identify and correct poor laboratory performance.  In 1992, I became Associate Director for Science at the CDC. My job was to provide scientific and technical advice to the agency, as well as to outside groups.

Currently, you serve as the Acting Director, Division of Laboratory Systems (DLS), National Center for Preparedness, Detection and Control of Infectious Diseases, CDC. What type of work do you do in this position?

This March, I became the Acting Director of the DLS at CDC. Our work at DLS falls into three areas represented by the three branches within the division. The Laboratory Practice Evaluation and Genomics branch conducts research into laboratory practices and helps us formulate the policies and the standards we should be recommending for laboratories. The Laboratory Practice Standards branch takes that research and writes policy and practice guidelines for laboratories. The standards work supports development of both voluntary standards such as those prepared by CLSI, as well as CLIA standards administered by the Center for Medicare and Medicare Services (CMS) providing the appropriate technical requirements for laboratories under the CLIA ’88 program. The Laboratory Systems Development branch works to enhance connectivity between clinical and public health laboratories to develop a national laboratory system and provides support globally for laboratory systems development with provisions for quality management systems.

What pressing issues are currently being addressed at the CDC?

There are several broader areas that the CDC, as an agency, is trying to address. The first area is emerging infectious diseases that are occurring all over the world and are making daily headlines including Avian Flu, the Ebola outbreak in the Congo, etc. CDC has employees providing constant surveillance for emerging infectious diseases all over the world. The second area is the group involved in chronic disease prevention. In addition to smoking and obesity considerations for the general population, there are other kinds of prevention activities that the group advocates. Another area that is very high on the list of CDC activities is preparedness. CDC works to ensure that our state and federal agencies are prepared to deal with any kind of hazard or emergency that might occur, whether it is a hurricane or biological attack. On a local level, we are trying to implement the quality management system (QMS) approach within all of the Coordinating Center for Infectious Diseases (CCID) laboratories. In particular, CLSI’s The Key to Quality is a product that CDC has been using and will continue to use. Recently, the DLS was invited by China CDC to provide QMS training and implementation for their laboratories for several years. The Key to Quality will be one of the primary documents for those efforts. 

Can you explain a bit about your involvement in professional societies outside of CLSI, including the American Association of Clinical Chemistry (AACC) and the American Chemical Society (ACS)?

I became a member of the ACS as an undergraduate in 1961. I was Chairman of the ACS Board Committee on Clinical Chemistry from 1989-1999. I joined AACC in 1972 when I was doing a postdoctoral in Clinical Chemistry at the University of Iowa. I have been active in AACC serving in various leadership roles in the Southeast section for over 30 years.

You have been involved in CLSI for over 20 years, including participation in the development of numerous consensus documents. What first initiated your involvement in CLSI?

Initially, I got involved with CLSI activities because of my role as a government policy setter. Before CLSI, there was a National Reference System for Clinical Laboratories. That group, which eventually became part of CLSI activities, was trying to standardize laboratory activities across the country. I believe that CLSI is fundamentally important as a standards development organization because it embraces government, industry, and academics. It brings together the strengths of all of these sectors to bear on the development of standards.

In your CLSI standards-development experiences, are there any highlights or resolved consensus issues of which you are particularly proud?

I am proud of one of the first documents that I worked closely on Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions (C24), which first came out in1985 when there was very little guidance or understanding for what was required. Another document important to me is Studies to Improve Patient Outcomes (HS6, 2004). The other documents I find particularly useful are A Quality Management System Model for Health Care (HS1) and Application of a Quality Management System Model for Laboratory Services (GP26).

As an expert in public health and clinical laboratory matters, what changes have you seen in the development of standards both nationally and globally? In addition, what do you see as the need for standards development in the future?

During the 1990s, development of international standards became very important. CLSI became the Secretariat for the International Organization for Standardization (ISO)/TC 212, which was truly a global effort to address standards. I was a charter member of that group, which produced some useful standards, including ISO 15189 –Medical laboratories – Particular requirements for quality and competence. I think the challenge is to get these standards implemented across the spectrum of laboratories worldwide. The commitment and resources to implement the standards are not always available to develop the laboratory's quality management system. Administrators are always looking at the bottom line. Quality is harder to quantify. If mistakes occur, they are recognized. If you have a measurement that is 10% more accurate than yesterday, would anyone notice the difference? Many documents focus on technical requirements, which are in the analytical part of testing. Errors occur and patient safety concerns are more prevalent in the preanalytical and postanalytical parts of testing, because there are transfers between different parts of the health care system. QMS documents address technical and management skills.

As you know, CLSI and CDC are partners in a cooperative agreement in support of the President's Emergency Plan for AIDS Relief (PEPFAR) program to provide capacity-building assistance for global HIV/AIDS laboratory guidelines and standards development in Africa. In your opinion, what are the key benefits of CLSI’s involvement in this educational and worthy cause?

I think the cooperative agreement has been a benefit to CLSI to understand the impediments to applying some of their standards internationally, in countries without reliable sources of water and electricity—the things we take for granted. On the other hand, it has been a tremendous benefit to the countries to see how sustainable high-quality laboratory operations may be achieved within their country. Even though they might not be able to implement all aspects, at least they have the goal to work towards and a common vision and a plan to incrementally accomplish it. I am glad CDC and CLSI have this partnership.

What do you see as a path forward for CLSI? More specifically, do you have any particular suggestions for what you would like to see happen in the organization now or in the future?

I think CLSI does an excellent job developing technical standards for US and global use. I have been advocating that CLSI think in terms of providing assistance in implementing the standards by presenting training activities or a mentoring program. The ideal program would be for committee members to serve for a period as advisors to organizations who want to implement the standards. Most of the CLSI documents are voluntary standards. By offering implementation support, CLSI will provide more assurance that the audience utilizes the standards. With the consensus process capturing the involvement of government, including the US Food and Drug Administration (FDA), CMS, and other regulatory agencies; industry; and professions; and a strong board of directors, CLSI will continue to be successful.