Division of Bacterial Diseases (DBD) News Bulletin
DBD Labs Pass CLIA with Flying Colors
Earlier this summer, laboratories within the Division of Bacterial Diseases (DBD) passed an important inspection, demonstrating that they meet federal quality standards. All U.S. facilities and sites that test human specimens for health assessment or to diagnose, prevent, or treat disease—including many CDC laboratories—undergo this inspection as part of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. Due to the extraordinary efforts of our labs, DBD passed the CLIA inspection with flying colors.
Preparing for CLIA inspection occurs year-round. DBD labs ensure that all their records, competency tests, proficiency tests, and other documents and tests, are continuously up to date. Preparation to become a CLIA-certified lab is a very rigorous, time-intensive and demanding process—but a necessary and important task. The emphasis placed on passing inspection cannot be overstated—if one lab at CDC fails the CLIA inspection, then all labs are affected and cannot work.
Labs must consider two important aspects to keep their CLIA laboratory classification. First, when new assays are added for CLIA certification, the protocols and records of sensitivity and specificity, among other documentation, must be documented in the CLIA manuals. Second, all labs within a branch eventually need to consolidate their paperwork for CLIA purposes—and this is challenging.
DBD has five labs in two branches. Preceding the June inspection, CDC conducted an internal assessment in November 2011 and 2012. DBD’s Associate Director for Laboratory Science, Kathy Tatti, noted that, “An important lesson learned is that the internal assessment performed by the CDC Laboratory Quality Management Program team is very useful for preparing for the CLIA inspection. All the findings and corrective actions noted by this team need to be addressed as soon as they are found.”
After the November 2012 assessment, the Respiratory Diseases Branch (RDB) worked to consolidate CLIA records from their two labs (Streptococcus Laboratory and Pneumonia Response and Surveillance Laboratory). This task, as well as addressing CLIA concerns, involved devoting one full-time staff member as CLIA manager for the branch. Kathy Thurman successfully undertook this effort from January through April. Kathy’s perseverance, hard work, and meticulous attention to detail were key to accomplishing the CLIA consolidation task for RDB. Working alongside Kathy was Lynne Shewmaker from the Streptococcus Laboratory.
Serving as CLIA designees of the three Meningitis and Vaccine Preventable Diseases Branch laboratories were Jordan Theodore (Meningitis Laboratory), Monte Martin (Pertussis and Diphtheria Laboratory), and Rita Desai (Microbial Pathogenesis and Immune Response Laboratory). They are meeting regularly, with Monte Martin taking the lead, to consolidate their labs in order to meet that CLIA requirement.
Looking forward, DBD’s laboratories will have CDC internal assessments in fall 2014 and a CLIA inspection in spring 2015.
Regards from Rana…
It’s been busy the last few months but we have much to celebrate and be thankful for this Holiday season! I want to mention a few. Our laboratories passed CLIA inspection with flying colors, yet another testimony to the high quality science these laboratories are conducting, but also the importance of teamwork. We received a grant from the Bill & Melinda Gates Foundation to support strengthening surveillance in the meningitis belt and demonstrate impact of MenAfriVac. DBD is making history by implementing a serogroup B meningococcal vaccine campaign at Princeton University to control an outbreak of meningococcal disease among students. We investigated a multitude of outbreaks, notably many Legionnaires’ disease ones. We just recently participated in a Public Health Grand Rounds on antimicrobial resistance that was very successful and highly attended.
In this bulletin, we highlight some critical public health activities that don’t always receive a lot of publicity (e.g., diphtheria, neonatal infections). Though diphtheria is rarely heard of in the United States any longer, it continues to cause unique challenges globally; DBD is working closely with our partners within and outside CDC to ensure this disease remains adequately controlled. Neonatal infections continue to be a major cause of deaths among infants worldwide, and through ANISA, DBD is playing a major role to understand the epidemiology of neonatal infections in order to develop better prevention strategies.
As we get close to the end of 2013, I would like to recognize many of our senior staff who retired over the last year. Just before Labor Day, we bid farewell to Brian Plikaytis, our beloved statistician who retired after 36 years of working at CDC and making major contributions to public health. Our retirees helped train hundreds of scientists over the years, and thus DBD continues its strong work improving prevention and control of bacterial respiratory and vaccine-preventable diseases in the United States and globally. Looking forward to another great year!
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