Description

Term: 3 months in 2023; expected time in-country is two-to-six weeks

Background & Objectives:

The recent COVID-19 pandemic and other large outbreaks have triggered critical discussions on how to address severe limitations to clinical diagnostics and surveillance capacity. Specifically, new and expanded molecular biology laboratory capacity is an urgent need in order to enhance pandemic preparedness systems and clinical laboratory services. Partners In Health (PIH) is a non-profit, global health organization that fights social injustice by bringing the benefits of modern medical science first and foremost to the most vulnerable communities around the world. PIH focuses on those who would not otherwise have access to quality health care and partners with the world’s leading academic institutions to create rigorous evidence that shapes more sound and all-inclusive global health policies. PIH also supports local governments’ efforts to build capacity and strengthen national health systems.

Currently operating in 11 countries, PIH supports Ministries of Health to provide direct care to millions of patients, through public facilities and community engagement. Laboratory systems are a core component of these clinical systems, and the PIH’s Pandemic Preparedness & Response (P3R) strategy focuses on laboratory strengthening in order to simultaneously improve the quality of clinical diagnostics as well as build capacity for robust and sustainable surveillance systems. This consultancy focuses on these core objectives by spurring a rapid assessment across several of the sites where PIH works to develop comprehensive operational plans for molecular biology laboratories.

The primary objective of the consultancy is to undergo comprehensive operational planning for first-time implementation of a molecular biology laboratory at one of several government hospitals that are supported by Partners In Health. This will include a rapid needs assessment and collaboration with teams across several PIH country sites in order to write a detailed ‘how to’ or operational guide that identifies key needs including but not limited to infrastructure, procurement, SOP development, technical expertise, HR needs, and policy, to envision new molecular labs as a future part of the existing clinical laboratory system and in consensus with existing molecular methods as per the respective Ministry of Health (MOH).

Molecular diagnostic capacity will provide the opportunity to perform genotypic identification and/or confirmation of various pathogens of interest, to inform the clinician for patient care and provide environmental surveillance. This consultancy will provide a plan identifying the missing needs and requirements for a molecular biology lab to perform RT-PCR. Specific objectives for this consultancy are the following:

Scope of Work:

• Work as part of a team across several PIH country sites to undergo rapid needs assessment and comprehensive operational planning for molecular lab capacity at a specific hospital in the assigned country(s).
• Join cross-site and global calls virtually on a routine basis to share lessons, match timelines, identify bottlenecks to the project, and address challenges.
• Identify other efforts, partners, and resources in molecular lab capacity in rural areas in low-income countries (to be performed with the cross-site team; each consultant will be responsible for identifying molecular laboratory efforts in the country where they are working).

• Communicate with in-country stakeholders to facilitate an enabling environment for addition or expansion of molecular capacity:

• Liaise with staff such as Lab Managers, Lab Staff, Chief Medical Officers, and Executive Directors to understand the context of the existing laboratory system in addition to requirements mandated or recommended by the respective MOH.
• Communicate with operational teams such as BioMed, Facilities, Supply Chain, etc. to perform tasks as identified below.
• Collaborate with other funding organizations (if applicable), where previous work in supporting molecular capacity has been implemented.

• Support technical and strategy discussions with key government stakeholders for common understanding of priorities and direction for molecular capacity and surveillance, with clear documentation of where the new initiative fits in and its goals/objectives.

• Identify specific molecular assays to be performed in the PIH-supported laboratory, in coordination with local and global leadership, based on anticipated test volume and population burden of disease.
• Develop an operational manual or how-to guide with all necessary details to implement a new molecular lab in the assigned country(s), including plans, costs, resource lists, and more for infrastructure, instrumentation, specific molecular assays, staffing, training, procurement, budgeting, etc. Activities may include:

• Infrastructure – analysis of the current lab space (or proposed molecular lab space, if applicable) to ensure the built environment will meet electrical, plumbing, and temperature specifications as needed, in addition to recommended renovation if space should be increased and/or designed differently to prevent contamination of genetic material.
• Instrumentation – inventory of the existing instrumentation and ancillary equipment to identify procurement needs, including but not limited to centrifuge, freezer, micropipettes, automated DNA/RNA extractor, thermocycler, UPS, etc.
• Procurement – identification of needed equipment, reagents, durables, and consumables based on anticipated testing volume, internationally and/or locally.

• Budget – based on findings mentioned above, work with the Cross-Site Lab and Sourcing teams to provide two budgets: one for total initial costs and one for monthly operational costs based on anticipated test menu and volume.
• Staffing – review existing team structure to ascertain if additional hiring will be needed, and to what extent.
• Training – identification of required training needed to perform molecular testing, in addition to support related to instrument maintenance and quality control.
• Quality Assurance and Quality Control – incorporation of existing quality measures to ensure new molecular testing is meeting lab guidelines and policies related to quality.

Administration

This consultancy is expected to last for a period of 3 months and to be completed by 31st October 2023. The consultant will directly report to the clinical director responsible for the lab program at Partners In Health in the respective country and will have a communication line to the cross-site lab coordinator in order to streamline, standardize, and share lessons and experience across 4 different countries who are concurrently working on molecular lab planning.

Deliverables:

The consultant is expected to submit the following deliverables:

1. A detailed and comprehensive manual or “how-to” guide for all aspects and steps for planning, initiating, and managing a molecular lab in a low resource setting, including:

• Comprehensive table of contents

• Technical sections including infrastructure, equipment, supply chain, staffing, etc., each detailing plans, costs, and standard operating procedures where relevant
• Estimated costs and timelines
• High quality formatting and branding consistent with cross-site team requirements

2. Training plans for specific content areas and needs for initiating molecular capacity

• May include training materials

3. All relevant SOPs
4. Detailed list of stakeholders consulted for the manual and documentation of meetings and decisions

Qualifications

• Master’s or doctoral degree (or equivalent) in biological sciences, public health, or similar field required.
• Minimum 5 years of experience in a professional, research, or academic laboratory focused on molecular biological applications.
• Familiarity with laboratory technique, diagnostic equipment, sample handling, and standard operation procedure (SOP) development.
• Geographic experience in the region, including knowledge of national laboratory standards and regulations
• Comfortable traveling on rough roads

• Exemplary interpersonal communication skills required to interact effectively with Lab Team members, senior leadership, and other partners and clinicians on issues related to diagnostics and laboratory.
• Ability to collaborate effectively with culturally diverse staff across departments and country.
• Ability to prioritize and take initiative on multiple and complicated tasks.
• Ability to work as an effective team member with the capacity to take initiative and work independently.
• Strong organizational skills and attention to detail in a fast-paced environment.

• Excellent interpersonal and rapport-building skills required.
• Sense of humor, patience, a positive attitude, and flexibility a must.
• Interest in social justice is strongly desirable.

Partners In Health (PIH) is committed to the fundamental principle of equal opportunity and equal treatment for every prospective and current employee. It is the policy of PIH not to discriminate on the basis of race, color, national or ethnic origin, ancestry, age, religion, creed, disability, sex and gender, sexual orientation, gender identity and/or expression, military or veteran status, or any other characteristic protected under applicable federal, state or local law. PIH works in and with a number of governments in and outside the U.S., and to the extent applicable, this statement is intended to incorporate the prohibition of any unlawful discrimination covered by applicable laws in such countries, states and municipalities.