Outline of the Project

Project Name

The Project for the Improvement of Safety and Quality Management Systems in Noguchi Memorial Institute for Medical Research

Subject

Health

Country

Ghana

Date R/D Signed

7 May, 2021

Project Site

Accra

Term of Cooperation

July 14, 2022 to July 13, 2025

Implementing Organization

Noguchi Memorial Institute for Medical Research of University of Ghana

Background

The Government's policy for the health sector is underpinned by the desire to attain Universal Health Coverage (UHC) in Ghana to the population through the attainment of the Sustainable Development Goals (SDGs). This includes to invest in having better preparedness and response system including the prompt diagnosis of illnesses including emerging infectious diseases, strengthening the capacity of the country for early warning, risk reduction and management of national and global health risks, including the prevention and control of outbreaks of deadly infections such as Ebola Virus Diseases, etc. Within this strategy, the Noguchi Memorial Institute for Medical Research (NMIMR) operates to provide advanced laboratory diagnosis to the Ghana Health Service (GHS) for outbreaks. The NMIMR also provides support to neighboring countries in this respect and has currently been identified as one of the nodal laboratories in the operations of the Regional CDC. The grant aid "the project for the constructing an Advanced Research Center for infectious diseases at the Noguchi Memorial Institute for Medical Research" was completed and the Advanced Research Center (ARC), including the new BSL3 laboratory, was built. The NMIMR already has good Standard of Operations (SOPs), but there are some gaps on maintenance, inventories, quality and safety issues.

The Overall Goal

The Quality Management System (QMS) in NMIMR meets the internationally recognized standards.

Project Purpose

The QMS is functional and improved on a continual basis in NMIMR.

Output

1. Quality Office and Safety Office are established and operational according to the defined Terms of Reference (TOR).
2. QMS is established and implemented institute-wide.
3. Institute-wide Biosafety and Biosecurity is strengthened.
4. Facility and equipment management of Advanced Research Laboratories (ARL) and all BSL-2 and 3 laboratories is strengthened.

Project Activities

1-1.	To develop and approve the internal regulations and procedures of Quality Office and Safety Office (e.g. ToR, holding of meetings, decision-making process, monitoring and evaluation, Quality Managers/Equipment Officers/Safety officers meetings, QMS training management procedures including the management of trainers).
1-2.	To conduct a needs assessment in order to 1) identify key processes, resources, documentation and records need to be developed and 2) determine training needs and candidate trainers.
1-3.	To develop a roadmap to specify needed actions to achieve the project purpose.
1-4.	To develop an activity plan of the Quality Office and the Safety Office annually.
1-5.	To implement the regular day-to-day activities defined in the activity plan (e.g. development of necessary documents, coordination of Quality Committee meetings, holding Quality Managers/Equipment Officers/Safety Officers meetings, management of Standard Operating Procedures (SOPs), provision of QMS trainings and support to departments/units).
1-6.	To conduct "training of trainers" in the area of quality management.
1-7.	To develop an internal audit programme.
1-7-1.	To plan internal audit.
1-7-2.	To train auditors and form an auditor team.
1-7-3.	To conduct internal audit.
1-7-4.	To follow-up the internal audit and provide necessary supports.
1-8.	To review the process and activities against the planned objectives and revise/renew the activity plan.
2-1.	To develop Quality policy and objectives, strategies, plan and budget, and Quality Manual of the institute by holding a stakeholder workshop.
2-2.	To secure budget necessary for ISO certification/accreditation or SLIPTA and its renewal in departments planning to have ISO or SLIPTA.
2-3.	To conduct a needs assessment in order to identify key processes, resources, and documents (SOPs etc.) need to be developed in each department.
2-4.	To develop Quality Policy, Strategies and Plan and determine the quality objectives and targets in each department.
2-5.	To conduct institute-wide QMS awareness campaigns.
2-6.	To develop and review/revise SOPs and conduct internal audit in each department with the support from the Quality Office.
2-7.	To conduct internal/external QMS training in each department based on the plan of Quality Office.
2-8.	To hold management review meetings to review and verify the process against its planned objectives, and identify measures for improvement.
2-9.	To implement the measures for improvement.
3-1.	To conduct a needs assessment to identify gaps and areas for improvement.
3-2.	To develop an activity plan of Safety Office annually based on results of the situation analysis and review of the plan.
3-3.	To develop an institutional Safety Manual, Safety programme and other necessary documents of the institute in consultation with the Health & Safety Committee.
3-4.	To develop a Biosafety and Biosecurity training programme in consultation with the Health & Safety Committee.
3-5.	To conduct internal/external trainings of departmental trainers on biosafety and biosecurity and to establish a pool of departmental trainers.
3-6.	To conduct departmental biosafety and biosecurity trainings for the staff.
3-7.	To develop and conduct drills and simulation exercises.
3-8.	To prepare after action reports of drills/simulation exercises.
3-9.	To review the process and activities against the planned objectives and revise/renew the activity plan.
4-1.	To conduct a needs assessment to identify gaps and areas for improvement (documentation process, training needs of the maintenance unit etc.) for the facility and equipment management of ARL and all BSL-2 and 3 laboratories.
4-2.	To develop necessary documents (e.g. guidelines, manuals, SOPs, and inventory) based on the needs identified by the needs assessment.
4-3.	To develop a maintenance programme (including periodic and preventive maintenance procedures, communication with laboratory staff etc.) and an annual activity plan by the maintenance unit and each departement.
4-4.	To conduct trainings for the maintenance unit and the departments.
4-5.	To implement maintenance programme activities.
4-6.	To review the process and activities against the planned objectives and improve the maintenance programme and annual plan.

Inputs
[Japanese side]

1. Dispatch of Experts
   (1) Project Coordinator/Training and Equipment Management(long-term)
   (2) Other experts on Chief Advisor, QMS, biosafety and biosecurity, equipment management etc. (short-term)
2. Equipment
   Project office furniture and equipment
   Equipment necessary for QMS
3. Training in Japan on BSL-3 laboratory management and operation, biosafety and biosecurity, QMS etc.
4. Local Cost
   Expenses necessary for implementation of the project activities such as trainings and workshops other than that are borne by the Ghanaian side.

Inputs
[Ghana side]

1. Assignment of counterpart personnel
2. Office space
3. Equipment necessary for QMS activities such as calibration equipment
4. QMS budget for the Project