Engagement of Consultant for training 20 Biomedical engineers and Equipment officers on Biosafety Cabinets Certification

Kingdom of Lesotho

Ministry of Health

REQUEST FOR EXPRESSION OF INTEREST

Terms of reference for biosafety cabinet certification training consultant

Department: Clinical Service

Job title: Consultant for training 20 biomedical engineers and Equipment officers on Biosafety Cabinets Certification

Project Southern Africa Tuberculosis Health Systems Support Project

LS-MOH-411496-CS-INDV-SATBHSS-AF-2024

BACKGROUND

Quality laboratory testing is crucial to confirm clinical diagnoses, conduct accurate infectious disease surveillance, and direct public health care policy. But, in this time of crisis, the current laboratory and health care infrastructures are insufficient to meet these needs and perhaps have been ignored. As seen during the ongoing COVID-19 pandemic, laboratories play important role to identify the infection, monitor trends and emergency of new strains, and even guide research and public health policy to prevent new infections and control the spread of the disease. Thus, laboratory systems, services, and networks constitute an integral part of a functioning health system.

Functioning equipment is essential for the smooth running of a laboratory (i) for reliable and reproducible results, (ii) for maintaining turnaround time established by a laboratory, (iii) for inspiring confidence in laboratory results so that clinicians intervene appropriately, and (iv) to help maintain credibility of the laboratory in the public health and health care system.

To sustain functioning laboratory equipment and prolong its life, staff must also be trained to carry out regular preventive maintenance as recommended by the manufacturer. Laboratories also need a curative maintenance contract with manufacturers, their representatives, or well-trained biomedical instrument technicians. Despite recognition of the need for remedial interventions, lack of laboratory equipment maintenance continues to pose a major threat to health system strengthening, with serious consequences for patient care and public health.

Biosafety cabinets play a crucial role in laboratories by providing containment for handling infectious biological materials. These cabinets protect both laboratory workers and the surrounding environment from potential hazards. Despite their central importance, many biosafety cabinets are not routinely tested and verified for correct functional operation and integrity.

OBJECTIVES OF THE ASSIGNMENT

The Government of Lesotho with the support of the World Bank through the Southern Africa Tuberculosis and Health Systems Strengthening Project aims to engage a consultant to train Biomedical engineers and Equipment officers on Biosafety cabinets certification. The consultant must be a highly qualified and experienced Biosafety Cabinet Certification Training Consultant to join our team. The consultant will be responsible for providing expert training and certification services in accordance with ANSI/NSF 49 standards to ensure the safe and proper operation of biosafety cabinets. The ideal candidate must possess ANSI/NSF 49 accreditation, TOT (Train-the-Trainer) certification, must be equipment management and calibration specialist with a proven track record of conducting similar trainings for multiple institutions. Will Train Biomedical engineers and Equipment officers on Biosafety cabinets certification.

SCOPE OF WORK, METHODS AND TOOLS

The Consultant shall work within 15 working days, starting from dates agreed on the contract. The methods of work hereunder shall complement the achievement of the objectives as aforementioned. Therefore, the consultant shall be responsible for:

• Biosafety Cabinets Certification: Conduct comprehensive training sessions on biosafety cabinet certification and maintenance in compliance with ANSI/NSF 49 standards.

• ANSI/NSF 49 Accreditation: Maintain ANSI/NSF 49 accreditation and stay updated on the latest standards and regulations related to biosafety cabinets.

• TOT Certification: Utilize TOT certification to train and certify individuals within client organizations as biosafety cabinet operators and maintainers.

• Consultation: Provide expert advice and consultation to clients on biosafety cabinet selection, installation, operation, and maintenance.

• Training Material Development: Develop and update training materials, manuals, and resources to ensure the effectiveness of the training programs.

• Assessment and Certification: Administer tests and assessments to evaluate trainees' knowledge and skills, and issue certifications upon successful completion of training programs.

• Client Relationship Management: Establish and maintain strong relationships with clients, addressing their specific training needs and ensuring their compliance with biosafety cabinet standards.

• Documentation: Maintain accurate records of training sessions, certifications, and client interactions for reporting and quality control purposes.

• Continuous Improvement: Stay informed about industry trends, best practices, and emerging technologies related to biosafety cabinets, and incorporate these into training programs.

SCOPE OF WORK, METHODS AND TOOLS

PowerPoint presentations and practical sessions will be used to deliver the content of the training.

And the practical will be done on three different facilities with three different Biosafety cabinets type representing the types available in the country as follows using the available tool kit:

American standard biosafety cabinets at NTRL -Maseru

• Hands on development of inflow and down flow grid patterns ANSI/NSF 49 and collection of airflow readings. Inflow measurements using DIM primary method

• Adjustment of airflow measurements to be within manufacturer’s specifications

• Smoke pattern tests

• Cabinet integrity tests

• Development of a biosafety cabinet certification report

European standard biosafety cabinets: Berea and St. Joseph’s Roma

• Hands on development of inflow and downflow grid patterns EN 12469 and collection of airflow readings. Inflow measurements using exhaust method.

• Adjustment of airflow measurements to be within manufacturer’s specifications

• Smoke pattern tests

• Cabinet integrity tests

• Development of a biosafety cabinet certification report

Biosafety cabinet troubleshooting and repairs at NRL Maseru

• Fumigation of a biosafety cabinet

• Replacement of HEPA filters

• Electrical troubleshooting exercises

• Site installation checks

• Commissioning and decommissioning of cabinets.

DURATION

The assignment is for a period of 15 working days

ASSIGNMENT OUTCOMES

• At the end of this training is expected that:

• The participants are able to conduct preventive and curative maintenance of the laboratory equipment; (Biosafety Cabinets)

• The participants are able to run the software and calibrate the laboratory equipment;

• The participants diagnose correctly the source of problems and conduct troubleshooting;

• The participants understand and use different tools on maintenance and calibration and certification

• The participants are able to monitor and generate period report of the usage of equipment.

DELIVERABLES