Appendix_C_to_RFP_W911QY16R0027_Task_Order_1.docx

ANCILLARY SERVICES TO SUPPORT EPIDEMIOLOGICAL RESEARCH TARGETS (ASSERT) AT NAMRU-3

Performance Work Statement (Task Order 0001)

This acquisition will provide program management, data management and scientific research support services for the Global Disease Detection and Response Program (GDDRP) under the U.S. Naval Medical Research-Unit 3’s (NAMRU-3) Research Science Directorate (RSD).

Administrative Requirements

a. Inspection/Acceptance/Points of Contact (DoDAAC): Dr. Mark Wooster, +20 122 211 0972, Mark.t.wooster.civ@mail.mil (N61751)

b. Inspection/Acceptance/LPO DoDAAC: N61751

c. Contracting Officer’s Representative (DoDAAC): Mr. Edilberto Calma, 301-319-9298, Edilberto.p.calma.civ@mail.mil (N32398)

d. Period of Performance: Performance shall be for 12 months from date of task order award.

e. Severability: This task is considered to be |_| severable or |X| non-severable (entire). For a non-severable requirement, this task order is considered non-severable because of the amount of research and performance required over an extended period of time such that any interruption in continuance of the particular performance would prohibit a meaningful deliverable to the Government client. Specifically: This requirement involves multiple research studies requiring management support that, if severed mid-performance, would adversely affect continuity and performance of ongoing investigations, which could potentially impact the delivery of meaningful deliverables to the Government as well as protocol approvals.

f. Completion or Term: This task is considered to be |_| completion or |X| term form. The completion form describes the scope of work by stating a definite goal or target and specifying an end product (e.g., a final report of research accomplishing goal or target) such that completion of the goal, target, or end product is necessary in order for the Government to successfully receive such benefit. The term form describes the scope of work in general terms and obligates the contractor to devote a specified level of effort for a stated period of time. A term or level of effort may have monthly and final reports but completion of such reports does not prohibit the Government from successfully receiving the benefit. The term form is not a time and material type contract or fixed labor rate contract in this context.

g. Security Clearance: Performance of this task order |X| does not require access and does not authorize access to classified information or |_| does require access and does authorize access to classified information up to and including the SECRET level and will have a DD254. For task orders that do have a security clearance requirement, Offerors are expected to demonstrate in the proposal possession of an active facility security clearance at the company level, including the name, phone number, and e-mail address of the company’s Facility Security Officer; and the name, phone number, and e-mail address of their cognizant DSS agent. Before extending an offer to the proposed candidates and processing personnel on this requirement for adjudication, first receive acknowledgement from the client on acceptance of their resumes and information from the client’s security representative concerning instructions for processing personnel clearances or government background checks.

h. Government Furnished Facilities (on-site) and Government Furnished Information:

(i) This task order |_| does not or |X| does require on-site contractor personnel to be located at Naval Medical Research-Unit 3 in Cairo, Egypt. This task order |_| does not |X| does represent a mix of on-site and off-site contractor personnel. Off-site locations may include the Ministry of Health in Cairo, Egypt, Ministry of Health in Amman, Jordan, Egyptian University Council in Cairo, Egypt, the Damanhour study site in Beheira Governorate, Lower Egypt, university and field surveillance sites in Al Hodeida, Yemen, and Camp Lemonnier, Djibouti. Contractor personnel and its subcontractors must comply and meet the requirements under Directive-Type memorandum (DTM 08-003, Homeland Security Presidential Directive-12 (HSPD-12) and Federal Information Standards prior to issuance of Personal Identity Verification (PIV) credential or Common Access Card. The applicable SF form can be sent either by the contractor or the client’s security office, depending upon the direction of the client’s security office, prior to contractor personnel arriving at agency to begin work. This task order |_| does not |X| does require proposed contractor personnel to have a favorable adjudication of the results of the background investigation. Those personnel performing on-site shall be processed in accordance with on-site base/command procedures (e.g., SF 86, CAC cards, personnel physicals, etc.), particularly: CAC Cards and/or US Embassy Badges. Contractor personnel performing at NAMRU-3 shall obtain U.S. Embassy clearance (for Egyptian Nationals) and must maintain the level of security required for the life of the contract. Contractor personnel must comply with all the onsite security requirements of the host command.

(ii) Health Insurance Portability and Accountability Act (HIPAA) of 1996 related guidance and requirements in accordance with BUMEDINST 7050.1B – Agreements with non-DoD entities: DoD commands are a Covered Entity as defined by the aforementioned BUMED instruction. However, in performance of its mission, the DoD command may and does contract out to non-DoD entities such that these non-DoD entities may have access to information covered under the HIPAA of 1996. When doing so, the DoD command must execute documentation in accordance with this instruction as it pertains to non-DoD entities by executing with the non-DoD entity a Business Associate Agreement (BAA, not to be confused with a Broad Agency Announcement). This task order |_| does not |X| does require a BAA and if so then the BAA is attached. This task order |X| does not |_| does require a Data Use Agreement or Data Sharing Agreement; Comment: The BAA is to be signed and submitted along with the contractor’s proposal in response to the RFP.

i. Government Furnished Equipment / Property: There is no GFE/P identified at this time that is unique to this task order. It should be noted that all contractor procured equipment under this task order (either for FFP or CPFF) is considered as a deliverable end item and ownership title is retained by the Government unless otherwise defined within the contractor’s proposal and approved by the client (FAR Subpart 45.4 applies).

j. Personal Services: This task order |X| does not or |_| does include personal services. This task order |X| does not or |_| does include Health Care Workers. This task order |X| does not or |_| does include clinical positions. Contract medical and dental services (such as those provided by clinicians) may be personal or non-personal in nature. In a Personal Services Contract (PSC), the contract health care workers appear to be Government employees and may have Government personnel exercise direct supervision and control over them such that an employer/employee relationship exist. Clinical positions are eligible for PSCs. However, these PSC contractor personnel cannot perform inherently Government functions such as supervision of Government or military personnel. For those clinicians performing under a PSC, they are covered under the Federal Tort Claims Act. Otherwise, clinicians performing as health care workers not under a PSC must be covered by indemnification and medical liability insurance provided by the contractor and as prescribed by FAR 52.237-7. Any Health Care Workers providing clinician services shall be certificated / registered in accordance with client-site requirements.

k. Indemnification of the Government by the Contractor and Requirement for Medical Liability Insurance: This task order |_| does not or |X| does require indemnification and medical liability insurance. If indemnification and medical liability insurance is required, then the offeror shall provide documentation in their proposal supporting the amounts recommended as acceptable coverage, including individual occurrence and aggregate limits. This insurance can cover the entire task order or the following positions: Contractor shall provide general liability insurance to cover the entire task order for prime contractor personnel. If applicable, the offeror shall identify how subcontractor personnel will be addressed.

l. Management Requirements: Monthly status reports will be accompanied by its matching invoice and DD250 for client approval/signature before submitting each invoice into the WAWF. Signed DD250 shall be uploaded into WAWF as an attachment to the monthly invoice (cost voucher for CPFF; combo for FFP for services and supplies; or 2-in-1 for FFP services only). An e-mail from the cognizant client can serve as a substitute for a signed DD250. In such case, the e-mail shall be uploaded into WAWF with the invoice. This process still applies for those contractors have DCAA/DCMA-approved direct payment authorization.

m. Human Research: There |_| is not |X| is human research involved with the client’s command mission. If there is human research involved with the client’s command mission, is there a copy of the IRB protocol in the contract file? |_| Yes |X| No. This task order |_| does not or |X| does require human-subjects research assurance certification by the contractor performer. If this task order is for research and involves human subjects, then the Human Research Protection Official (HRPO) |_| has |X| has not reviewed this document to ensure that appropriated information is included in the solicitation and subsequent award. The contact information for the HRPO is: (1) Name of person: Mohamed Abdel Fattah (2) phone: +20 223421375, ext. 345 (3) e-mail: Mohamed.abdelfattah.eg@med.navy.mil (4) name of command: NAMRU-3. The RFI/RFP (or award, if applicable) and approved IRB documents were sent to HRPO/DoD responsible office for review on _______________. This task order is for |X| intramural (DoD) |_| extramural (non-DoD) research. Research herein involving human subjects |_| has |X| has not been separated into an option that would not be exercised until all documentation is provided. Research with human subjects may not begin until the contractor obtains either a DoD granted Institutional Assurance or a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). Additionally, all research must be approved by an Institutional Review Board (IRB) named in the Assurance application and the cognizant DON HRPO before the research commences. A copy of the approved DoD Assurance, along with all IRB approval documentation, shall be provided to the technical point of contact assigned to the specific delivery order, and to the IRB of the Navy institution being supported, before any human subjects research begins. All DoD supported research must also comply with the Health Information Portability and Accountability Act (HIPAA) Privacy Rule, and related DoD instructions. Any task order that does require research on human subjects requires that the DoD component be responsible for contractor oversight of compliance with 32 CFR Part 219, Protection of Human Subjects; and that the Government personnel responsible for such oversight is the client’s Human Research Protection Official as defined by DFAR 252.235-7004, Protection of Human Subjects. All research needs to be determined to be compliant with federal and Department of Defense regulations for protecting human subjects. All studies similarly need to be compliant with the requirements of the Health Information Portability and Accountability Act (HIPAA) Privacy Rule. Further, evolving human subject protection regulations need to be investigated and training plans developed to educate researchers as to their human subject responsibilities. Contractor shall support Institutional Review Board (IRB) functions and HIPAA Privacy Office functions by reviewing all command studies, including those in the areas of medical resource planning, enhancing performance during shipboard and ground operations, investigating and monitoring disease incidence among military personnel, development of computer systems for monitoring the physiologic status of individual patients, clinical research studies, survey administration efforts, and evaluating physiological effects of various agents found in military operational environments. Such support shall include analyzing research protocols to determine compliance with relevant human subject protection regulations and drafting administrative correspondence detailing review proceedings and findings. Support shall also include development of educational materials, monitoring of research, and database development for tracking of research protocols. If human-subjects research assurance certification is required, then the offeror shall provide a copy of the FWA in their proposal. Comment: A Federalwide Assurance (FWA) is required for this task order.

n. Animal Use: There |_| is not |X| is animal use involved with the client’s effort. If there is animal use involved with the client’s effort, is there a copy of the IACUC protocol in the contract file? |_| Yes |X| No. This task order |_| does not or |X| does require animal use assurance and accreditation by the contractor performer. Any task order that does require the use of animals in research shall be compliant with all applicable federal and DoD regulations, specifically including 7 U.S.C. 2131 et. Seq. and 9 CFR 1-4, “Animal Welfare Act”; DoDI 3216.01, “Use of Animals in DoD Programs”; and specific DoD component management plans. Evolving animal use and care regulations need to be investigated and training plans developed to educate researchers regarding their animal use and care responsibilities. Contractor shall support Institutional Animal Care and Use Committee (IACUC) functions and comply with any procedures required for IACUC approval, including research protocol submission, Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation, Department of Health and Human Services (DHHS) Office of Laboratory Animal Welfare (OLAW) assurance, and USDA site inspections. Comment: The NAMRU-3 assurance and accreditation may be used by the contractor, provided that contractor employees and/or subcontractors comply with all requirements and regulations.

o. Organizational Conflicts of Interest (OCI): There |_| is not or |X| is an identified potential or perceived OCI within this task order. If there is an identified potential or perceived OCI, then the technical proposal shall include as an attachment an OCI Mitigation Plan for review/approval by the client / Contracting Officer. Acceptance of this task order by the contractor shall not create an OCI condition, either for legacy work being performed or future work to be bid or performed. The OCI Mitigation Plan shall include Non-disclosure Agreements signed by the personnel performing on this task order and counter-signed by their management. The OCI Mitigation Plan and NDAs shall state: “This document does not authorize access to another company’s proprietary or sensitive information.” Comment: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may effect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

p. Market Research: This requirement |_| is not or |X| is over the Simplified Acquisition Threshold. In the case of the latter, a Market Research doc was developed (for Government use only).

q. Other Contract Requirements:

(i) This SOO has been reviewed and contains no services that are inherently Government functions.

(ii) Performance of this SOO may include access or exposure to private information subject to compliance to FAR Subparts 52.224-1 and 52.224-2.

(iii) Performance of this SOO may include dissemination of information / publishing subject to compliance with client requirements.

(iv) This SOO may include data that is subject to data right restrictions by the client.

(v) One FTE = 1,920 hours. The local workweek is Sunday through Thursday from 0800 to 1630 except for Egyptian and US national holidays specified in accordance with the US Embassy mission schedule.

(vi) All travel in support of Navy Medicine task orders must be deemed mission critical and written approval from the proper chain of command must be obtained before the travel takes place. Contractors must adhere to the travel approval process in accordance with the client command’s travel policy and BUMED Memorandum “Travel Approval in Navy Medicine” issued on 10/7/13.

(vii) Comply with Contractor Manpower Reporting requirements.

(viii) For task orders requiring Reporting of Inventions or patent related matters, including during closeout of task orders, and for those that are for an NMRC enterprise command, such forms shall be processed via NMRC legal, which is currently staffed by Dr. Albert Churilla. The processing of DD 882s is not restricted to the time period at closure of this task order. That is, as the technology/science develops, a DD 882 shall be filed when potential title to intellectual property is first identified.

(ix) The key criteria associated with this contract is that the prime contractor will work in conjunction with local solution partners or subcontractors to ensure that local sourcing is utilized to the fullest, thereby giving the NAMRU-3 client the most cost effective solution, while maintaining a level acceptable performance. Any prime contractor working in Egypt or in-theater AOR will ensure compliance with all tax and labor laws, including multi-tier taxable income tax rates, Social Insurance Law (such as Social Security) covering Egyptian employees as well as foreign employees whose countries have treaties with Egypt for reciprocal social insurance treatment, employer compliance obligations as defined under Egyptian law, work permit/visa requirements, indirect taxes, compliance with business registration laws, and local taxes including double taxation. Same applies to other countries where comparable and applicable. (There is no threshold/minimum number of days that exempts the employee from the requirements to file and pay tax in Egypt.) There is also compliance with the cognizant US command of the relevant regions and the US State Department, as there is high risk when entering into the area.

(x) Unique contractor payment processing: There may be some unique contractor payment processing because of the international nature of this acquisition (for example, the use of local payment vouchers).

(xi) Contractor is to be familiar and compliant with Egyptian laws concerning Egyptian citizen employees and companies working within Egypt, or whatever country performance is conducted in.

ADDENDUM

ANCILLARY SERVICES TO SUPPORT EPIDEMIOLOGICAL RESEARCH TARGETS (ASSERT) AT NAMRU-3

GLOBAL REQUIREMENT

The U.S. Naval Medical Research Unit No. 3 (NAMRU-3) is the oldest overseas military medical research facility and one of the largest research laboratories in the North Africa-Middle East region. The laboratory traces its origins to 1942, when America military scientist and technician began working with Egyptian physician at Abbassia Fever Hospital, Cairo, Egypt under the auspices of the United States of America Typhus Commission, established by President Franklin D. Roosevelt. Following World War II, the Egyptian Government invited the U.S Navy to continue collaborative studies of endemic tropical and subtropical diseases with Egyptian scientist. NAMRU-3 was formally established in 1946, and the laboratory has been in continuous operation despite periods of political tension and a seven-year lapse in U.S-Egyptian relations (1967-1973). NAMRU-3 conducts research and surveillance to support military personnel deployed to Africa, the Middle East, and Southwest Asia. NAMRU-3’s mission includes the evaluation of vaccines, therapeutic agents, diagnostic assays, and vector control measures. It’s primary mission is to study, monitor, and detect emerging and re-emerging infectious disease threats of military and public health significance and to develop mitigation strategies against these threats in partnership with host nations, international agencies, CENTCOM, EUCOM and AFRICOM AOR.

NAMRU-3’s Research Science Directorate (RSD) programs include the Bacterial and Parasitic Diseases Research Program, the Global Disease Detection and Response Program (GDDRP), the Vector Biology Research Program, the Viral and Zoonotic Disease Research Program, the Cooperative Biologic Engagement Projects, the Ghana detachment in Accra, Ghana, and the Animal Resources Department and its CAP accredited laboratory.

This acquisition will provide program management, data management and scientific research support services for GDDRP. GDDRP is one of the programs under NAMRU-3’s RSD with a mission to strengthen public health, epidemiology, and laboratory capacity of health organizations in Egypt, West Africa, and the Eastern Mediterranean Region to detect, prevent and respond to infectious diseases of national and international importance. GDDRP supports obligations under joint agreements between NAMRU-3, US Centers for Disease Control and Prevention (CDC) and the Ministry of Health, Arab Republic of Egypt (MOPH). GDDRP works in collaboration with NAMRU-3 in Egypt, the Eastern Mediterranean Region, North and West Africa.

SPECIFIC REQUIREMENTS

The key criteria associated with this contract is that the prime contractor will work in conjunction with local solution partners or subcontractors to ensure that local sourcing is utilized to the fullest, thereby giving the NAMRU-3 client the most cost effective solution, while maintaining a level of acceptable performance.

Activities to accomplish the aforementioned requirement to completion include:

1. Information Technologist (IT) Specialist/Data Manager A. The IT Specialist/Data Manager will manage data entry, reporting and archiving of data from 40 hospitals in Egypt. The IT Specialist/Data Manager will provide training to local hospital staff on basic data management issues and use of personal digital assistants (PDAs) for the 40 hospitals. In addition, the IT Specialist/data manager will set up two central hubs in the Ministry of Health and the Ministry of Higher Education. She/he will support 3 pilot hospitals to report data electronically on hospital infections to the two central hubs. Technical expertise is required on the conceptual design and development of the surveillance reporting system, specifically on issues of how to harmonize data reporting across hospitals in various governorates. The IT Specialist/Data Manager will be responsible for meeting the following objectives:

a. Design and implement a data collection and management system for the infection control Team at the Global Disease Detection and Response Program. This comprehensive data management system should link epidemiological and laboratory data from multiple surveillance systems in 40 hospitals throughout Egypt. The IT Specialist/Data Manager will work with epidemiologists, laboratory scientists, and others to develop and maintain the database systems.

b. Responsible for the design of data collection systems using both paper forms and PDAs, database system maintenance and troubleshooting.

c. Responsible for database security, database system backup and recovery plans.

d. Support epidemiologists and infection control specialists in analysis of large complex databases.

e. Provide training, assistance, advice and guidance to PDA and database system users in both administrative and technical aspects of the system.

f. Troubleshoot problems involving the input, retrieval or modification of database information and the general operation and maintenance of data systems.

g. Interface with IT personnel at NAMRU-3, the Ministry of Health, and other organizations in the resolution of problems, recommendation of database modifications and system upgrades or enhancements.

h. Purchase, program and distribute the required equipment and PDAs to the newly participating hospitals.

i. Upgrade and develop two central data hubs, one at the Egyptian University Council and the second one at the Ministry of Health in Egypt.

j. Establish IT infrastructure in three hospitals for data collection and electronic reporting to the two central hubs: Prepare 3 hospitals as pilot sites using a Server Network System. Instead of having data files emailed from each PDA to the Infection Control Team (IC) as is currently done, Server Network computing offers Internet-based real-time data sharing and reporting. Additionally, the Server Network will provide a wireless Internet connectivity to all PDAs in each 3 hospital sites. The IT data infrastructure in each hospital will be enhanced and upgraded to include a secure wireless network, providing communication between the Servers’ databases the PDA devices. The minimum system requirement for hospital reporting is having Windows SQL Server Application licensing, smart phones (No. depending on the number of ICUs), data gathering desktop computer and monitors, wireless routers, server units, Internet Service Provider (ISP), internet modem, training, maintenance and support.

k. Responsible for development of Software: The current software Questionnaire Management (QM) being used on PDAs will be reprogrammed to flag the records update or added by users. Additionally, denominator data which is currently collected manually will be changed so that the denominator number is captured on the PDA during data entry. An application component will be added to the PDAs to extract and send the updated and newly added records to the server instantaneously. Second, server side components will be developed such as Data merging, Data reporting, User management, and Scaling up plan of ICU surveillance Web interface(interface through which all the system functions can be accessed from anywhere in the world).

l. Responsible for assigning and supervising admin and technical staff to support the work of the project.

m. Submit the following reports: NAMRU-3 and CDC monitoring and evaluation, weekly Dashboard, Collaborations and reports to the funding agency (see Delivery Schedule below).

B. Deliverables:

Updates in the monitoring and evaluation data base

Sr. Administrative assistant responsible for preparing the GDDRP program report of entry into the database

Report of collaborations with partners including CDC and WHO EMRO

Update of the CDC monitoring and evaluation spreadsheet

2. Surveillance Coordinator (Infectious Disease) A. The Surveillance Coordinator will be qualified in epidemiological and laboratory –based surveillance procedures to provide technical and managerial expertise to implement a laboratory-based surveillance program for hospital-acquired infections (HAIs) and antimicrobial resistance (AMR) in 40 hospitals in Egypt and upgrade the capacity of the 29 hospital microbiology laboratories. The Surveillance Coordinator will be responsible for meeting the following objectives:

a. Assign administrative and technical contractor staff for completion of activities:

i. The Surveillance Coordinator will assign administrative and financial subcontractors to help accomplish the requirements of the contract and will be responsible for paying per diems, transportation costs, and supplies necessary for the accomplishment of the work.

ii. The Surveillance Coordinator will be responsible for assigning 2 investigators qualified in monitoring and evaluation of surveillance programs

b. Surveillance in intensive care units (ICU surveillance) in 40 hospitals and surgical site infection surveillance (SSI) in 10 hospitals:

i. Develop 6 training packages focusing on surveillance procedures for HAIs and AMR as follows:

· Two-day training package to transition 30 hospitals who have been implementing phase II surveillance to phase III surveillance

· Four -day training package targeting surveillance coordinators in 10 hospitals newly participating.

· Three -day laboratory training package for pathogen identification and susceptibility testing

· One-day Information technology training package on use of PDAs for data entry and reporting.

· One-day training package for intensive care unit physicians on “Diagnosis and Treatment of hospital-infections”

· Two-day training course on surveillance procedures for surgical site infections

ii. Conduct the following 6 training courses:

· Two-day training of 120 surveillance coordinators in 30 hospitals on transitioning to phase III surveillance once in April 2014

· Four-day training course of 80 surveillance coordinators in 10 hospitals on how to implement phase III surveillance (in April and September 2014) twice per year.

· One-day training course of 40 data managers in 40 hospitals on data entry and reporting for phase III in May 2014

· One-day training of 150 ICU physicians on diagnosis and treatment of hospital infections twice per year

· Conduct a one-day training course to 40 infection control teams from 10 hospitals 5 times per year on SSI surveillance procedures

c. Surveillance Advocacy meetings targeting hospital directors, intensive care unit (ICU) directors, and hospital infection control teams:

i. Conduct the technical task force Conduct the technical task force meetings twice per year (for one day) for 32 senior high officials

ii. Conduct a kick-off event to launch phase III surveillance program including senior health officials, hospital directors, directors of ICUs, hospital infection control teams (100 participants )

iii. Conduct an advocacy and feedback meeting to 50 hospital directors of hospitals participating in the surveillance program (three times per year)

iv. Conduct an advocacy and feedback meeting to 130 ICU directors (three times per year)

v. Advocacy meeting to 20 hospital directors (for one day, four times per year) to promote surgical site infection surveillance procedures.

vi. Conduct an advocacy meeting for SSI prevention to 40 hospital infection control teams (three times per year)

d. Travel for assessment and monitoring of hospitals and surveillance procedures:

i. The aim of the trips is to evaluate, monitor the performance on regular basis and solve any anticipate problems in implementation.

e. Improve Microbiology Laboratory Capacity at 29 hospital labs:

i. Raise the capacities of 29 hospital microbiology laboratories to conduct pathogen identification and susceptibility testing of pathogens causing hospital infections according to international guidelines.

ii. Prepare needed lab training packages and SOPs.

iii. Identify the hospital lab focal persons for training.

iv. Arrange laboratory training courses at NAMRU-3 and on-site by selecting training facilities, preparing training files for distribution and essential training material for the courses.

v. Provide a two-day microbiology training course targeting 15 lab persons 10 times per year.

vi. Document laboratory training activities by shooting pictures and organizing them in a data base.

vii. Purchase and distribute essential laboratory supplies to 29 participating hospital laboratories.

viii. Ship isolates from participating hospital laboratories to NAMRU-3 laboratory for quality control purposes.

f. Miscellaneous activities:

i. The Surveillance Coordinator will be responsible for purchasing personal protective equipment for infection control and distribute to hospitals according to their needs. Personal protective equipment purchased should be gloves, masks, protective barriers and others (quantities and expenses should not exceed $2K). Types and quantities purchased should be approved by the principal investigator of the program.

ii. The Surveillance Coordinator will be responsible for submission of technical reports on quarterly basis including progress and challenges, numbers trained, evaluation of training and number of advocacy meetings performed.

iii. The Surveillance Coordinator will be responsible to document all training and advocacy activities by shooting pictures and organizing them in a data base.

B. Deliverables:

Electronic

Sr. Administrative assistant responsible for preparing the GDDRP program report of entry into the database

Reports to the funding sources, such as USAID

3. Laboratory Capacity Manager A. The goal of this effort is to further Egypt’s compliance with World Health Organization (WHO) International Health Regulations 2005 (IHR). This will be achieved by strengthening laboratory capacity in Public Health Laboratories from selected governorates and Cairo and by implementing standard quality management protocols to improve sample management and biosecurity and to fill other gaps identified through laboratory assessments. The Laboratory Capacity Manager will be responsible for meeting the following objectives:

a. Design action plans with activities that are related to the IHR and monitoring and evaluation framework developed for the Egypt Public Health Laboratory in collaboration with the World Health Organization Eastern Mediterranean Region.

a. Identify, with Egypt Ministry of Health and Population (MOHP) input and consideration of safety and security concerns, 5 governorates to participate in lab capacity building activities.

b. Identify gaps in laboratory capacity that must be filled to reach IHR compliance through analysis of previous laboratory assessments.

c. For laboratories assessed, define action plans based on the gap analysis conducted in each laboratory.

d. Support laboratories in closing gaps through follow-up visits, and step-wise trainings in bio-risk management or other needed methods that will be provided by subject matter experts and hosted by Animal Health Research Institute.

e. Develop and implement a sample management program for pending and archived samples.

f. Support travel for laboratorians from CPHL to provide or receive trainings related to outbreak response.

g. Submit the following reports: NAMRU-3 and CDC monitoring and evaluation, weekly Dashboard, Collaborations and reports to the funding agency (see Delivery Schedule below).

B. Deliverables:

Updates in the monitoring and evaluation data base

Sr. Administrative assistant responsible for preparing the GDDRP program report of entry into the database

Report on activities for the activity and/ or Dashboard report

Report of collaborations with partners including CDC and WHO EMRO

4. Surveillance Coordinator (HAI and AMR) A. Provide surveillance coordinating services in support of sentinel surveillance for Severe Acute Respiratory Illness (SARI) and Hospital-acquired Infection (HAI) surveillance in Jordan. Jordan is one of the countries participating in the regional network for establishing sentinel surveillance sites for severe acute respiratory infections including influenza. The Eastern Mediterranean Network for Acute Respiratory Infections (EMARIS) aims at supporting all countries in the region to establish and sustain sentinel sites implementing surveillance for severe acute respiratory infections (SARI), to describe the epidemiology of respiratory pathogens in Jordan and serve as an early warning system for potential influenza outbreaks and/or pandemic flu. Surveillance for hospital-acquired infections (HAIs) is an important activity to estimate the burden of disease of HAIs and antimicrobial resistance (AMR). The GDD/NAMRU-3 is committed to support the MOH in Jordan establish and sustain a surveillance program for SARI, HAIs and AMR and institute prevention measures to reduce the spread of infections in hospital settings. The project will also improve national capacity of Jordan in the area of surveillance, epidemiology, diagnostic laboratory procedures, and infection control. GDD/NAMRU-3 is committed to continue supporting the MOH in Jordan to sustain sentinel surveillance sites, particularly after the latest Novel Corona Virus outbreak reported from Jordan in November 2012. The Surveillance Coordinator will be responsible for meeting the following objectives:

a. SARI Surveillance:

i. Assist in overseeing and supervising all activities related to the NAMRU-3 surveillance activities for SARI at 3 participating sentinel sites in Jordan.

ii. Contractor, in collaboration with the Principle Investigator at NAMRU 3, is responsible for identifying the hospital surveillance coordinators conducting the SARI surveillance.

iii. Conduct continuous training for the central, regional, and hospital level to ensure appropriate implementation of the surveillance activities in compliance to the regional standard procedures for SARI surveillance.

iv. Coordinate efforts of contractor staff to obtain good quality epidemiological data.

v. Ensure appropriate collection of nasopharyngeal and oropharyngeal swabs from patients enrolled in the surveillance, and will ensure proper processing and testing of collected samples to the regional lab standards.

vi. Ensure collected samples are preserved and transported to the Central Public Health Laboratory for processing and analysis.

vii. Ensure that collected samples are preserved and transported to NAMRU-3 laboratory for quality control purposes every 3 months World Courier and packaged according to UN ECOSOC, ICAO, IATA and 42 CFR Part 72 regulations.

viii. Ensure regular data entry of the SARI data collection form and sending the database to GDD/NAMRU-3 on bi-weekly basis.

ix. Ensure informing and acknowledging NAMRU-3 and CDC for any official or printed reports, or presentations related to the SARI protocol.

x. Shall be responsible for paying per diems, transportation costs, and supplies necessary for the accomplishment of the work.

xi. Shall submit a technical progress report describing the performance and achievements on quarterly basis.

b. HAI and AMR surveillance:

i. Ensure renewal of official approvals from the ministry of health, and/or hospital administration required conducting surveillance activities for HAIs and AMR.

ii. Implement HAI and AMR surveillance in intensive care units of 5 hospitals including El Basheir, Totangi, Prince Hamza, Jerash, and El Zarqa.

iii. Train all hospital infection control teams in the 5 hospitals on surveillance and laboratory procedures of HAIs and AMR.

iv. Hold a workshop for all 5 hospital staff for exchanging data and solving problems.

v. Print out all data collection forms required for the surveillance system.

vi. Provide regular monitoring and evaluation of surveillance activities in intensive care units of 5 hospitals, identifying and reporting problems.

vii. Provide support to the hospital laboratories by purchasing and distributing lab supplies required to isolate, store and transport the bacterial pathogens.

viii. Ensure collected samples are preserved and transported to the Central Public Health Laboratory for processing and analysis.

ix. Ensure that collected samples are preserved and transported to NAMRU-3 laboratory for quality control purposes every 3 months and packaged according to UN ECOSOC, ICAO, IATA and 42 CFR Part 72 regulations.

x. Contractor is responsible for paying per diems, transportation costs, and supplies necessary for the accomplishment of the work.

xi. Contractor will ensure regular data entry of the HAI surveillance data and sending the database to GDD/NAMRU-3 on monthly basis.

B. Deliverables:

5. Epidemiologist (GDDRP) A. The Epidemiologist will provide services to support the activities of the GDDRP efforts in Egypt, the Eastern Mediterranean Region and West Africa in consonance with GDDRP’s mission including technical assistance, data collection, analysis and reporting, training, protocol development and Institutional Review Board (IRB) submissions, report and manuscript writing, and other duties that are within scope of the required epidemiological services. The Epidemiologist will be responsible for meeting the following objectives:

a. Assist senior epidemiologists in establishing and implementing emerging infectious disease program (baseline) activities and current and future special projects in Damanhour.

b. Conduct substantive literature reviews, and/or analysis of existing literature and data.

c. Draft and oversee submission of protocols, grant applications, IRB documents, guidelines, standard operating procedures, and training manuals.

d. Draft data collection instruments or questionnaires for use in paper, PDA and web-based formats.

e. Assist in data collection, management, and analysis.

f. Assist in the preparation of reports and manuscripts, including summarizing data in various formats (tables, graphs, posters, abstracts, and oral and written reports).

g. Assist in conducting outbreak investigations, trainings, health utilization surveys, and networking activities.

h. Monitor the progress of assigned projects and evaluate performance toward meeting protocols and work plans.

i. Develop materials for presentations, including trainings, workshops/meetings, and conferences.

j. Submission of weekly, bi-weekly, monthly, and quarterly reports for GDDRP/NAMRU-3, key partners (including the Ministry of Health) and funders, and the Centers for Disease Prevention and Control

k. Perform various other tasks in conjunction with GDDRP operations, including logistical support that is within scope of the task order.

B. Deliverables:

Electronic

Sr. Administrative assistant responsible for preparing the GDDRP program report of entry into the database ; Mrs. Amal El Dessouky; amal.eldessouky.eg@med.navy.mil

6. Special Projects Manager/Coordinator A. The Damanhour District, located in the Delta region of Egypt, was selected as the site for a collaborative effort between NAMRU-3, CDC, and the Egyptian Ministry of Health to establish a population-based surveillance site for respiratory pathogens, diarrhea, acute febrile illness, tuberculosis and acute neurological infectious disease. The International Emerging Infectious Program (IEIP)/Damanhour laboratory was renovated in 2009 to meet U.S. Department of Defense international laboratory standards. Surveillance activities have been implemented since June 2009. Surveillance of ARI began in three Damanhour hospitals and expanded to include acute infectious neurologic diseases in 2010, and acute febrile illnesses and surveillance of influenza like illnesses in 2011 at the outpatient departments of these hospitals. The IEIP site in Damanhour has been designated as a Center of Excellency for Disease Surveillance and training by Egypt’s Ministry of Health and Population. Several special projects have been included or will be amended to the Population-Based Surveillance Protocol in order to build upon the existing disease surveillance platform. These specific projects will address environmental improvements at study sites, build local public health capacity, and short-term public health research projects. These projects include:

a. Digitization of Chest X-rays for development of objective standards of pneumonia diagnosis

b. Enrollment of a control population to compare risk factors, base serological levels, and asymptomatic pathogen carriage of healthy persons with cases

c. Research to identify atypical bacterial pneumonia with TB co-infection

d. The establishment of a private physician network in Damanhour for capacity building and expansion of disease surveillance to the private sector

e. Environmental improvements at the study sites, with special emphasis in regards to vector control The Special Projects Manager/Coordinator will oversee additional projects conducted outside of the usual surveillance conducted at the surveillance site in the Damanhour District, located in the Delta region of Egypt and be responsible for meeting the following objectives:

a. Oversee all activities related to a variety of special projects beyond the surveillance platform of the Population-based Surveillance for Selected Infectious Diseases protocol in Damanhour, Egypt. Work closely with the Principal Investigator or Investigators for all International Emerging Infections Program Research projects conducted at this site and assist in coordinating the activities of other contractor personnel with IEIP/CDC/MOHP/NAMRU-3 for the purposes of these studies.

b. Provide administrative oversight and facilitating field activities at study sites associated with 1) Digitization of chest x-rays, 2) control population enrollment, 3) private physician network development, 4) sputum collection for TB and pneumonia co-infection research, and 5) Environmental improvements at study sites.

c. Facilitate collaboration between the Ministry of Health and Population’s (MOH) Health Directorate office in the Beheira Governorate, the MOH’s International Emerging Infections Program, and NAMRU-3 throughout the course of the projects.

d. Identify and supervise all contractor staff necessary for conducting special projects 1-5 in item b above.

e. Organize and supervise appropriate training for contractor staff associated with special projects.

f. Assist the IEIP/NAMRU-3 to ensure that the contractor personnel recruited for IEIP/NAMRU3 studies are properly trained for their respective projects, including recruitment of parents/guardians and their…