ASM LabCap’s contributions to disease surveillance and the International Health Regulations (2005)

The revised International Health Regulations [IHR(2005)], which requires the Member States of the World Health Organization (WHO) to develop core capacities to detect, assess, report, and respond to public health threats, is bringing new challenges for national and international surveillance systems. As more countries move toward implementation and/or strengthening of their infectious disease surveillance programs, the strengthening of clinical microbiology laboratories becomes increasingly important because they serve as the first line responders to detect new and emerging microbial threats, re-emerging infectious diseases, the spread of antibiotic resistance, and the possibility of bioterrorism. In fact, IHR(2005) Core Capacity #8, “Laboratory”, requires that laboratory services be a part of every phase of alert and response. Public health laboratories in many resource-constrained countries require financial and technical assistance to build their capacity. In recognition of this, in 2006, the American Society for Microbiology (ASM) established an International Laboratory Capacity Building Program, LabCap, housed under the ASM International Board. ASM LabCap utilizes ASM’s vast resources and its membership’s expertise—40,000 microbiologists worldwide—to strengthen clinical and public health laboratory systems in low and low-middle income countries. ASM LabCap’s program activities align with HR(2005) by building the capability of resource-constrained countries to develop quality-assured, laboratory-based information which is critical to disease surveillance and the rapid detection of disease outbreaks, whether they stem from natural, deliberate or accidental causes. ASM LabCap helps build laboratory capacity under a cooperative agreement with the U.S. Centers for Disease Control and Prevention (CDC) and under a sub-contract with the Program for Appropriate Technology in Health (PATH) funded by the United States Agency for International Development (USAID). Successful activities of ASM LabCap have occurred throughout Africa, Asia, Central America and the Caribbean. In addition, ASM LabCap coordinates efforts with international agencies such as the WHO in order to maximize resources and ensure a unified response, with the intended goal to help build integrated disease surveillance and response capabilities worldwide in compliance with HR(2005)’s requirements.

ASM LabCap helps build laboratory capacity under a cooperative agreement with the U.S. Centers for Disease Control and Prevention (CDC) and under a sub-contract with the Program for Appropriate Technology in Health (PATH) funded by the United States Agency for International Development (USAID). Successful activities of ASM LabCap have occurred throughout Africa, Asia, Central America and the Caribbean. In addition, ASM LabCap coordinates eff orts with international agencies such as the WHO in order to maximize resources and ensure a unifi ed response, with the intended goal to help build integrated disease surveillance and response capabilities worldwide in compliance with IHR(2005)'s requirements.

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and public health labora tory systems in low and lowmiddle income countries, primarily through the training and onsite mentoring of laboratory staff . Th e program began in 2006 as a result of the fi rst CDC/DGHA-ASM cooperative agreement. ASM is well-equipped to play a major role in the global fi ght against infectious diseases. More than 5,000 ASM members are clinical microbiologists, many with years of experience developing laboratory quality assurance (QA)/quality control (QC) programs, managing laboratories, instituting good laboratory practices, providing training for performance of laboratory duties, and designing diagnostic tools and procedures. ASM LabCap rapidly engages these experts from around the world to develop and roll-out laboratory training and mentoring programs. Th ese successful activities have to-date occurred in 17 countries: Botswana, China, Côte d'Ivoire, Guatemala, Guyana, Haiti, India, Kenya, Mozambique, Namibia, Nigeria, Rwanda, Tanzania, Th ailand, Vietnam, Zambia, and Zimbabwe.
As more countries move toward implementation of infectious disease surveillance programs, such as required by IHR(2005), the strengthening of clinical microbiology laboratories becomes increasingly impor tant because they serve as the fi rst line responders to detect new and emerging microbial threats, re-emerging infectious diseases, the spread of antibiotic resistance, and the possibility of bioterrorism. In fact, IHR(2005) Core Capacity #8, "Laboratory", requires that laboratory services be a part of every phase of alert and response, including detection, investigation and response, with laboratory analysis of samples performed either domes tically or through collabor ating centers. States Parties thus need to establish mechanisms for providing reliable and timely laboratory identifi cation of infectious agents and other hazards likely to cause public health emer gencies of national and international concern [2].
Although not specifi cally designed in the context of IHR(2005), ASM LabCap's program activities align with this eff ort by building the capability of resource-constrained countries to develop quality-assured, laboratorybased information which is critical to disease surveillance and the rapid detection of disease outbreaks, whether they stem from natural, deliberate or accidental causes. In the elaboration of its programs, ASM LabCap coordinates eff orts with international and U.S. govern ment (USG) agencies and non-profi t organizations such as the WHO, the U.S. Agency for International Develop ment (USAID), divisions of the CDC, and other international organizations in order to maximize resources and ensure a unifi ed response.
ASM LabCap's various programs directly contribute to global laboratory capacity building eff orts. Th ese activities include: Under the direction of the U.S. Global AIDS Coordinator's Offi ce, CDC/DGHA is a partner in the unifi ed USG eff ort to implement PEPFAR. Th e CDC's longstanding partnerships with ministries of health around the world support improvement of critical infrastructure and services to build sustainable national public health capacity and help resource-constrained countries prevent HIV infection and improve treatment, care, and support for people living with HIV/AIDS. ASM LabCap's partnership with CDC/DGHA has focused primarily on laboratory diagnostic strengthening for TB and other HIV/AIDS-related opportunistic infections (OIs). ASM LabCap staff and consultants travel to countries to provide onsite technical assistance and mentoring in an eff ort to help establish and fully transfer quality-assured laboratory diagnostic capacity to laboratorians. Ongoing activities include: • Assessing laboratory systems and laboratory capacity mapping • Mentoring and training of laboratory staff • Providing technical support for the customization and rollout of consensus training packages and programs • Assisting with the strengthening of laboratory quality systems, including development of QC procedures, QA programs, and standard operating procedures (SOPs) • Providing guidance for the standardization and selection of equipment and reagents • Establishing, optimizing, and validating laboratory tech niques and procedures • Assisting with the establishment of national public health/reference laboratories • Supporting the development of specimen referral networks • Assisting with the coordination of infectious disease surveillance and outbreak response • Developing national strategic plans for public health laboratory networks • Guiding the development or optimization of national laboratory policies • Assisting laboratories in their preparations for accreditation • Developing a certifi cation program for laboratory personnel Key elements of the IHR(2005) laboratory core capacities are laboratory capacity mapping, specimen collection, hand ling, and transport, biosafety, laboratory-based investi gation, QA, and reporting/communications [3]. ASM LabCap activities, as outlined above, are consistent with these except for laboratory-based investigation. Note Table 1, which outlines select ASM LabCap country activities.

ASM LabCap-CDC training cooperation
ASM LabCap has assisted CDC with developing and rolling out training events for laboratory personnel capacity building. Th ese events include two international courses on Acid-fast bacilli (AFB) smear microscopy external quality assessment (EQA), one in English in Tanzania and one in French in Senegal; a national Frenchlanguage Mycobacterium tuberculosis (Mtb) culture, identifi cation, and drug susceptibility testing (DST) in Côte d'Ivoire; seven national basic microbiology workshops in Botswana, Kenya, Mozambique, Tanzania, and Zambia; and a national workshop for laboratory support of enteric disease outbreak surveillance and response in Kenya. A brief description of these programs follows.

AFB Smear Microscopy EQA workshops -Tanzania and Senegal
ASM LabCap facilitated two fi ve-day workshops entitled "Strengthening AFB Smear Microscopy EQA Programs", one in English in December 2009 in Dar es Salaam with participants from Angola, Bahamas, Barbados, Botswana, Ethiopia, Jamaica, Kenya, Lesotho, Malawi, Mozambique, Namibia, Rwanda, Swaziland, Tanzania, Vietnam, Zambia, and Zimbabwe, and a francophone version in August 2010 in Dakar with participants from Senegal, Cameroon, Haiti, and Côte d'Ivoire. In line with Article 44 of the IHR(2005), which calls for States to share technical cooperation and assistance in order to strengthen and maintain public health capacities, these platforms allowed the participating countries to network and share experiences, challenges, best practices, and lessons learned from EQA implementation, as well as assess new opportunities to integrate AFB smear microscopy into other laboratory disciplines. ASM LabCap is providing follow-up support to many of the participating countries.

French-language Liquid Culture and DST course
From February 22 through March 5, 2010, ASM LabCap and CDC/PEPFAR-Côte d'Ivoire organized in Abidjan, Côte d'Ivoire, its fi rst course on Mtb culture, identi fication and DST for French-speaking African laboratorians. Scientists, managers, and technicians from the National TB Program and four major Ivorian TB laboratories attended the two-week course held at the National TB Reference Laboratory housed in the Pasteur Institute of Côte d'Ivoire (IPCI). Th e course was the fi rst national training event in Côte d'Ivoire to help increase detection and reporting of multi-drug resistant (MDR)-TB using newer, more rapid technology. TB, in its MDR and extensively drug resistant (XDR) forms, is a disease with the potential of causing public health emergencies which fall within the scope of IHR(2005). Its early detection, control, and containment in endemic regions of Africa, such as Côte d'Ivoire, are steps towards improving international public health security.

Basic clinical microbiology course -Botswana, Kenya, Mozambique, Tanzania, and Zambia
ASM consultants have facilitated workshops on basic bench top procedures for clinical microbiology for a total of 145 participants thus far. Th e goal of each workshop, as developed by an ASM LabCap Committee Member, was to enable clinical microbiology laboratory technologists to instruct clinicians on proper choice and collection of patient samples for microbiological studies, to properly handle the samples in the laboratory with respect to initial testing and culture processes, to adequately identify the major pathogens in each site (and to not report non-pathogens), and to perform necessary antimicrobial susceptibility tests (AST) on those pathogens. Th ese procedures are encompassed in a series of fl owcharts and are demonstrated with real cultures and organisms. Participants learned in the laboratory by performing the procedures themselves. A list of the reagents and simple supplies used in the laboratory were provided to the participants for training and QC purposes in their own facilities. ASM LabCap places consul tants in-country to work with the various participating laboratories as a follow-up to the training.
Course topics covered during these workshops relevant to the IHR(2005) included procedures for AST, detection of Vibrio cholerae, and other pathogen-causing epidemic diarrheal diseases, meningococcal meningitis, and respiratory infections.

CDC-ASM Joint Workshop for Laboratory Support of Enteric Diseases Outbreak Surveillance and Response -Kenya
Since 2008, there have been ongoing diarrheal outbreaks in Kenya that have spread to several districts throughout the country, including Nairobi. Performing accurate and timely laboratory identifi cation of the etiological agents of outbreaks has been challenging for Kenya's District and Provincial hospitals, which have limited skills and resources. Consistent with IHR(2005)'s focus on strengthening laboratory-based surveillance systems for epidemic-prone diseases such as cholera, in October 2009, 39 district-based laboratory technologists, surveillance offi cers, and clinical offi cers convened in Nairobi for a workshop designed to build their capacity to provide support in enteric disease outbreak surveillance and response. Th is eff ort was a collaborative endeavor between CDC/GDD (Global Disease Detection) Kenya Th e trainees were presented with the basic principles of epidemiology and outbreak detection; determination of proper samples to collect in an outbreak; collection, packaging, and transport of biological samples from an outbreak; and rapid testing for detection of Vibrio cholerae, Shigella dysenteriae Type 1, Salmonella enterica serovar typhi, and Shiga toxin-producing E. coli from biological samples. Furthermore, ASM LabCap facilitators discussed essential microbiological procedures and techniques for processing samples and traditional methods for culture, identifi cation and susceptibility testing of the four enteric pathogens. Overviews of Gram staining, laboratory diagnosis of common HIV-related OIs and other outbreak pathogens, QC, and media preparation were also included.

International Emerging Infections Program (IEIP) initiatives
IEIP is an international eff ort by the CDC as part of its Global Disease Detection Program to built capacity around the world to detect emerging infectious disease. ASM LabCap is providing technical expertise and consultation for building laboratory capacity and improving clinical microbiology for the diagnosis of respiratory diseases in select IEIP sites. Each site is set to implement active, population-based surveillance for pneumonia with varying levels of microbiological capacity. Below are descriptions of the IEIP sites that ASM LabCap has supported to-date, and the specifi c support provided by ASM.

China
Th e U.S. CDC and China's CDC collaborate to conduct active surveillance for patients hospitalized with community-acquired pneumonia in China. A threemonth pilot project evaluating procedures for patient enrollment and specimen collection, transport, testing, and reporting, was conducted from mid-November 2008 to February 2009 in three sites (Panjin, Liaoning Province; Jingzhou, Hubei Province; Zhuhai, Guangdong Province). Patients enrolled in this study had specimens collected for microscopic examination, bacterial culture, viral culture, urine antigen testing, and polymerase chain reaction (PCR)-based identifi cation. During the pilot, ASM LabCap evaluated the capacity at each site to perform non-PCR based testing, to provide guidance regarding necessary supplies and equipment at each site, and to write SOPs. ASM LabCap also provided additional technical guidance for the fi nalization of the study protocol.

Guatemala
ASM LabCap worked with the CDC-Guatemala offi ce for Central America and Panama and the Guatemalan Ministry of Health to provide technical expertise and consultation for improving the diagnosis of respiratory diseases in Guatemala. ASM LabCap visited labs in Guatemala City and Cuilapa and reviewed blood culture processing and provided recommendations for improving species identifi cation, particularly Streptococcus pneumoniae, using the available BacT/Alert automated blood culture system. ASM LabCap additionally off ered guidance for optimizing susceptibility testing via disk diff usion.

Thailand
Th e Th ai provinces of Nakhon Phanom and Sa Kaeo are part of an active-population based surveillance system for community-acquired pneumonia under a Th ai Ministry of Public Health (MOPH) -U.S. CDC collaboration. Each has a major hospital with additional small hospitals and clinics. ASM LabCap evaluated procedures for specimen collection, transport, processing, culture, and identifi cation primarily for the detection of Streptococcus pneumoniae and provided recommendations to improve and refi ne their procedures.

ASM-PATH collaboration in India
Th e Government of India has allocated substantial funding for developing integrated disease surveillance, with laboratory capacity building as an essential component and TB as a targeted disease for improved surveillance. Since November 2008, ASM LabCap has been working with PATH, on a USAID-funded initiative, to strengthen the capacity of the Intermediate Reference Laboratory (IRL) network to perform Mtb culture and DST (expected to expand to one IRL/state or territory or over thirty laboratories). Th e ultimate goal of this initiative is to ensure that selected IRLs obtain national accreditation, i.e., be deemed fully profi cient in Mtb culture and DST by an overseeing National Reference Laboratory (NRL). States (or territories) with accredited IRLs will then be able to conduct drug resistance surveys (DRS) and implement the DOTS-Plus strategy to treat MDR-TB. Activities

Conclusion
Th e IHR(2005) core capacity laboratory requirements are bringing new challenges for national laboratory systems; these requirements include improved diagnostic capacity, better connectivity intersectorally and internationally, and better quality of laboratory data and reporting. Public health diagnostic laboratories in many resourceconstrained countries lack laboratory involvement in disease surveillance, advocacy or resources, supporting infrastructures, biosafety awareness and practices, and pathogen security practices [3]. Th ese countries require fi nancial and technical assistance to build their diagnostic laboratory capacity. ASM LabCap, through partnerships with the WHO, CDC, and USAID, among others, has been assisting various WHO States Parties with acquiring needed laboratory diagnostic capacity, both as related to human resource and infrastructural developments. Th ese activities are providing resource-constrained countries with the necessary tools to improve their public health laboratory infrastructure, which will enable them to move towards compliance with IHR(2005) requirements. Th e scope of ASM LabCap's work enables indigenous laboratorians to more rapidly and eff ectively identify and respond to a broad spectrum of diseases of public health relevance. Th e activities are designed around creating sustainability and primarily focused on human resource development, specifi cally involving local entities in designing and customizing laboratory training tools that address their particular needs while still meeting international standards.
Th rough the achievements of programs such as ASM LabCap, there is an increased visibility of the critical role laboratories play in health systems, helping advocacy eff orts and garnering additional resources for laboratory capacity building eff orts, as well as promoting the full integration and participation of laboratorians in the planning and implementation of national and international disease surveillance systems. Furthermore, ASM LabCap's targeted training and mentoring programs are transferring quality-assured laboratory skills to laboratorians with outcomes that indicate that the quality of the laboratory data are greatly improving, including data recording and reporting mechanisms. ASM LabCap is implementing in each of the supported laboratories a quality management system (QMS) approach that emphasizes the use of SOPs, guidance documents, QA/ QC procedures, biosafety practices and participation in successful EQA schemes; moving the laboratories toward international accreditation is a key activity of ASM LabCap.
In 2006, the WHA made a resolution relative to the immediate and voluntary compliance with IHR(2005); it included a request to "expand and accelerate training eff orts in the areas of…laboratory capacity, including regional networking of laboratories, biosafety, and quality control…", and in 2008, the WHA resolved to pay close attention to the sub-Saharan African laboratory network [4]. ASM LabCap is actualizing an accelerated response to defi ciencies in laboratory capacity in many sub-Saharan African countries by helping the countries defi ne and implement laboratory policies and guidance documents, map their public health laboratory capacity, develop human resources capable of implementing IHR(2005) laboratory core capacity requirements, off er laboratory services to test for priority health threats, institute laboratory biosafety and biosecurity practices, and network on a regional and international level, in support of Article 44 of IHR(2005), and expressed in the 2006 and 2008 WHA resolutions.
Meeting IHR(2005) requirements by 2012 will require a great deal of partner collaborations and coordination. Th e USG is increasing its engagement in IHR(2005) capacity-building. As ASM LabCap is currently primarily supported by USG agencies as a technical arm for assisting low and low-middle income countries with improving their laboratory disease detection capacity, it is anticipated that future projects will be more directly conceptualized in the context of IHR(2005). In addition, ASM LabCap will continue its active collaboration with the WHO and other international organizations in order to further coordinate eff orts for building integrated disease surveillance and response capabilities worldwide.