Clinical and Laboratory Services in Cameroon

PERFORMANCE WORK STATEMENT (PWS) 1. 0 GENERAL 1.0 General: This is a non-personal services contract to provide clinical and laboratory services to the Naval Medical Research Unit-EURAFCENT (NAMRU-EURAFCENT). 1.1 Background: The U.S. Naval Medical Research Unit-EURAFCENT (NAMRU-EURAFCENT) is an infectious diseases research institute of the United States Navy. NAMRU-EURAFCENT conducts research that enhances warfighter readiness by executing scientific research and surveillance initiatives throughout the USAFRICOM, USCENTCOM, and USEUCOM areas of responsibility. This is a non-personal service contract for study coordination and support for two research projects executed in partnership with the Cameroon Armed Forces (CAF), the Military Health Research Center (CRESAR) in Yaoundé, the Douala and the Yaoundé Military Hospitals: 1. Acute Undifferentiated Febrile Illness (AUF) Project: “NAMRU-3 Network Surveillance for Epidemiology of Malaria and Non-Malaria Acute Undifferentiated Febrile Illnesses” This is a prospective surveillance study of acute undifferentiated fever and malaria to characterize the organisms causing these infections, conducted at the Douala Military Hospital. 2. Surgical Site Infection (SSI) Project: “Genotypic Surveillance for Antimicrobial Determinants Responsible for Drug Resistance in Bacterial Pathogens Causing Wound Infections”. This prospective study monitors surgical wound infections at the Yaoundé Military Hospital to characterize resistance genes of infecting pathogens and evaluate wound care procedures in relation to resistance and infection. 1.2 Scope: The primary responsibility of the contractor is to coordinate the execution, logistics, and accomplishment of clinical and laboratory research activities at the Douala Military Hospital (Douala, Cameroon), the Yaoundé Military Hospital (Yaoundé, Cameroon), and the CRESAR laboratory (Yaoundé, Cameroon). The contractor must ensure that all ethical, regulatory, and study protocol requirements are fulfilled for both projects. 1.3 Objectives: The primary objective is to provide clinical and laboratory support to NAMRU-EURAFCENT projects for acute febrile illnesses and surgical wound infections in Cameroon military and government medical facilities. 2.0 REQUIREMENTS The contractor shall ensure the following services are provided in accordance with applicable regulations, and local policies and procedures: 2.1 The contractor shall ensure that all site-specific research activities are conducted in adherence to both approved study protocols: “NAMRU-3 Network Surveillance for Epidemiology of Malaria and Non-Malaria Acute Undifferentiated Febrile Illness” and “Genotypic Surveillance for Antimicrobial Determinants Responsible for Drug Resistance in Bacterial Pathogens Causing Wound Infections”. DRAFT -- 1 of 13 -- 2.2 The contractor shall serve as the primary clinical and logistical coordinator and liaison, ensuring seamless, real-time communication between the clinical hospital sites in Douala and Yaoundé, CRESAR laboratory, and NAMRU-EURAFCENT. 2.3 The contractor shall serve as the primary liaison with the Cameroon research ethics committee. The contractor shall proactively manage and coordinate all submissions for annual continuing reviews, and protocol amendments to secure uninterrupted local ethical approvals. Documentation of all ethics approvals shall be submitted via email to the NAMRU-EURAFCENT TPOC within three (3) business days of receipt. 2.4 The contractor shall recruit a team of qualified medical and laboratory personnel for clinical and laboratory study sites for both projects. For the AUF project in Douala: At a minimum, the team includes a study coordinator (0.3 FTE), hospital physicians (0.3 FTE), phlebotomists (0.3 FTE), hospital laboratory technicians (0.3 FTE), a hospital supervisor (0.2 FTE), and a logistics officer (0.1 FTE). For the SSI Project in Yaoundé: At a minimum, the team includes a study coordinator (0.3 FTE), surgeons (0.3 FTE), nurses (0.3 FTE), a hospital supervisor (0.2 FTE), a CRESAR laboratory supervisor (0.2 FTE), a bacteriologist at CRESAR (0.3FTE) and a logistics officer (0.2 FTE), 2.5 The contractor shall train the study staff on enrollment and project clinical procedures before the beginning of the projects, and as needed, during the duration of the projects. The training shall cover research ethics, patient screening and recruitment, execution of informed consent (IC) procedures, accurate questionnaire administration, and sample collection. All training material and methods shall adhere to the Study Specific Procedures (SSP) provided by NAMRU-EURAFCENT. 2.6 The contractor shall implement and maintain standardized screening processes to identify eligible subjects visiting the clinical sites presenting with acute febrile illness (for the AUF study) or surgical wound infections (for the SSI study). 2.7 The contractor shall ensure that properly executed informed consent procedures are carried out for all enrolled subjects in strict adherence to ethical guidelines prior to any study-related procedures. 2.8 The contractor shall ensure that study enrollment and sample collection do not interfere with the standard of clinical care received by patients at the participating military hospitals. 2.9 The contractor shall ensure that detailed study questionnaires are fully and accurately administered for all enrolled subjects. 2.10 For the SSI Project in Yaoundé: a. The contractor shall ensure the enrollment of a minimum of 500 and a maximum of 700 surgical site infection cases per year. The contractor shall ensure the proper collection of surgical wound swabs by trained clinical personnel in compliance with the protocol and NAMRU-EURAFCENT SSP/SOPs. b. The contractor shall manage the proper handling, short-term storage in the hospital, and transfer of all biological specimens from the hospital to the CRESAR laboratory. c. The contractor shall coordinate bacteriology testing, including Gram…