Department of Public Health and Social Services Guam Public Health Laboratory (GPHL) March 11, 2014

GPHL Updates: Completed Validation for Rubella and Rubeola IgM Cepheid GeneXpert PCR – set up, training and validation testing Cepheid GeneXpert Clinical Trials for Chlamydia and GC PCR – 1st quarter of 2012 Acquisition of New Applied Biosystems 7500 Real Time PCR System Set-up/install and train staff on new Applied Biosystems (AB) rt-PCR instrument BT Suite Renovation Completed

Update cont’d. Acquired and started use of Artel PCS pipette calibration instrument (2012) New tests on the Cepheid GeneXpert: Influenza PCR (A/B, 2009 H1N1) – Sept 2012, Chlamydia/GC PCR (urine, genital specimens) – Sept. 2013 Adopted the new CDC-recommended HIV testing algorithm (Biorad HIV Ag/Ab Combo, Biorad Multispot) – Nov. 2013 – capable of confirming HIV

Challenges: Funding to procure supplies, reagents and equipment to sustain current test menu Funding to procure supplies, reagents and equipment for future tests (e.g. water analysis, food testing) Training of staff in different updated processes in bacteriology Training of staff in influenza testing to improve and maintain competency

Plans for Building Capacity Level 2 Capacity building at GPHL 2014 – 2015: An SPC-PIHOA Collaboration Initiative: Provide training to skill-up microbiology lab diagnostic capacity Provide preparatory training for the enhancement of public health food and water microbiology lab capacity Provide technical assistance to strengthen lab-based surveillance of PPHSN outbreak-prone diseases Start validation of the following tests on the Cepheid GeneXpert: MTB/RIF, C. difficile PCR Awaiting CDC approval to acquire influenza and dengue RT-PCR reagent kits for AB 7500 PCR instrument for validation studies Start Validation for Water Analysis If AB 7500 RT-PCR instrument is capable of testing for bacterial agents in food-borne illnesses, start validation process

Plans for Building Capacity Cont’d. Renovate GPHL TB suite to conform with updated safety practices, to be followed by acquisition of instrument for MTB culture and sensitivity Department of Interior Funding approved for the renovation and purchase of a BACTEC MGIT 960 system Expand influenza panel testing to detect other subtypes Installation and training for the NEDSS (National Electronic Disease Surveillance System (NBS) for surveillance. Installation, set up, training for the Indian Health Services’ Resource patient Management System (RPMS) – laboratory information system with instrument interface and automated reporting.

Future Plans January 2014 – Governor of Guam informed that 13million dollars was approved for a new GPHL under the Department of Defense (OMNIBUS Appropriations Act of 2014) as part of the military buildup. Proposed Mission Statement: To provide diagnostic services to regionally important diseases and conditions that may impact the health of the community and region, and serve as a regional center of excellence for reference testing including evaluations of new diagnostic tools and training.

Projected Capabilities of New GPHL Upgraded from Biosafety (BSL) 1/2 to BSL 2/3 equipped to test clinical, environmental and radiological specimens Bacteriology and Virology Department: Basic bacterial cultures Confirmatory testing (i.e. salmonella, shigella, cholera) Susceptibility testing for different bacterial pathogens such as gonorrhea Testing for bacterial toxins from clinical and environmental samples and viral cultures

Cont’d. Serology/Immunology Department Molecular Diagnostic Department Dengue, leptospirosis, pertussis, measles, rubella and other infectious diseases. Screening for radioactive substances will be added to the test menu if instrumentation and training is provided. Molecular Diagnostic Department Expanded nucleic acid amplification test capabilities that will allow for influenza and dengue subtyping, and other pathogens in which non-culture tests are helpful in outbreak mitigation. Mycobacteriology Department Upgraded to perform not just acid-fact bacilli (AFB) smear microscopy but AFB culture, identification and drug susceptibility testing.

Sustainability Funding for staffing and laboratory operations is projected to be maintained through Government of Guam sources, HHS/CDC cooperative agreements, and current plans to develop a revolving fund through legislation to established a fee schedule for services. Partnerships with Department of Defense centers, including the Naval Health Research Center may be considered to provide additional support for sustainment.

Regional Plan The new GPHL will serve the DPHSS and also have the potential to provide confirmatory testing for numerous stakeholders and partners including other US Affiliated Pacific Island laboratories. Vision of GPHL is to serve as the regional hub for laboratory testing and training in Micronesia