RFPtenderdocument.pdf

Regulatory framework (Mandatory) DBT-ICMR National Guidelines for BSL-3 Laboratory, 2024 (as updated from time to time)

Notwithstanding any review, approval, consent, or acceptance provided by AIIMS Patna or its authorized representatives at any stage of the project—whether in respect of designs, drawings, technical specifications, reports, equipment selection, validation protocols, construction-stage technical support and design-intent compliance review, or any other deliverable or process—the consultant/selected bidder shall remain fully and exclusively responsible and accountable for the accuracy, completeness, technical soundness, regulatory compliance (including but not limited to DBT-ICMR National Guidelines, 2024 and any amendment thereon), biosafety/biosecurity integrity, and overall fitness-for-purpose of all services and deliverables provided under this engagement.

The consultant/selected bidder further undertakes to carry out all necessary corrections, revisions, revalidation, or remedial measures at their own cost, without any additional financial liability to AIIMS Patna, in the event that any deliverable, even if previously approved, is found to be non-compliant or deficient at any point prior to (during) final operational handover/certification process.

The establishment, design, construction, commissioning, validation, certification support, and operational-readiness planning of the proposed facility shall be governed primarily by the DBT-ICMR National Guidelines for Biosafety Level-3 Laboratory, 2024, as amended or updated from time to time.

The facility shall also be planned in alignment with applicable statutory, regulatory, biosafety, biosecurity, environmental, biomedical waste, building, fire safety, engineering, and institutional requirements, including the Environment (Protection) Act, 1986, Rules relating to hazardous microorganisms/genetically engineered organisms or cells, applicable IBSC/RCGM requirements, National Building Code, relevant BIS/IS codes, CPCB/BPCB requirements, CPWD guidelines and other applicable national and international best practices/guidelines (latest), wherever relevant.

The selected A&E Consultant shall be responsible for providing integrated professional services covering site verification, existing facility assessment, retrofitting assessment, biosafety risk assessment, laboratory workflow planning, containment zoning, architectural planning, engineering design, HVAC and containment engineering, MEP and utility design, building automation and monitoring systems, BIM, CFD analysis, equipment planning, technical specifications, DPR, cost estimates, BOQ, subsequent tender document, pre-bid &

(vi) The proposed facility is required to function as a safe, compliant, maintainable, certifiable, and operationally efficient BSL-3 laboratory with associated BSL-2/support areas, proper personnel/material/sample/waste flow, controlled access, negative pressure containment, HEPA filtration, decontamination systems, emergency provisions, monitoring and alarm systems, and appropriate redundancy for critical systems.

The design shall not be limited to indicative inputs provided by AIIMS Patna; rather, the A&E Consultant shall apply its professional expertise, independent assessment, domain knowledge, biosafety expertise & understanding, compliance, engineering competence, and regulatory experience to develop a complete, coordinated, fit-for-purpose, and certification-ready design solution duly executable at construction and certification level.

(vii) This RFP is therefore issued for selection of a competent A&E Consultant capable of delivering the technical foundation for subsequent execution, commissioning, validation, certification, and operational readiness of the proposed BSL-3 laboratory at AIIMS Patna.

The A&E Consultant shall be responsible for assessing the existing facility/infrastructure, identifying required retrofitting and engineering interventions, developing the master plan, preparing biosafety risk assessment and workflow planning, designing containment and engineering systems, integrating architectural, MEP, HVAC, utility, automation, monitoring, laboratory equipment, BIM and CFD requirements, and preparing all technical documentation required for mandatory clearances (such as fire safety/environmental clearance etc.), procurement, construction, commissioning, validation and certification.

The A&E Consultant shall ensure that the proposed solution is practical for execution, suitable for tendering, verifiable during construction, and capable of supporting successful commissioning, validation, biosafety validation and certification processes.

(iv) The consultancy services shall result in a complete package of deliverables, including site assessment, design basis documents, master plan, containment zoning strategy, workflow plans, coordinated drawings, engineering calculations, BIM outputs, CFD analysis, technical specifications, equipment utility requirements, cost estimates, DPR, BOQ, tender documents, construction-stage technical review inputs, commissioning and validation support documents, certification-support documentation, and as-built / handover records etc., as required under this RFP.

(v) The A&E Consultant shall not merely reproduce the indicative requirements provided by AIIMS Patna, but shall apply its professional expertise, independent assessment, biosafety knowledge, engineering judgment and regulatory understanding to develop a complete, coordinated and fit-for-purpose solution.

(i) The Bidder shall submit, as part of its Technical Bid, a preliminary Need Assessment Note for the proposed BSL-3 Laboratory at AIIMS Patna, based on the information provided in this RFP, the existing building details, indicative laboratory activities, proposed equipment profile, applicable biosafety requirements, and the Bidder’s professional understanding of similar high-containment laboratory facilities.

The Need Assessment shall not be a mere reproduction of the RFP provisions. It shall reflect the Bidder’s independent professional assessment of what is required to convert the identified existing building space into a safe, compliant, functional, maintainable, and certification-oriented BSL-3 laboratory facility.

(iii) The Need Assessment Note shall, at minimum, cover the Bidder’s assessment of functional laboratory requirements, BSL-3 and associated BSL-2/support area requirements, personnel/material/sample/waste workflow, containment zoning, pressure cascade requirements, HVAC and HEPA filtration needs, utility and power redundancy requirements, decontamination and waste management needs, equipment integration requirements, access control and security needs, emergency and safety provisions, validation and certification requirements, and key risks requiring attention during design and execution.

(iv) The Bidder shall also identify any additional requirement, gap, constraint, assumption, interface issue, or clarification which, in its professional opinion, may affect design development, tender preparation, construction execution, commissioning, validation, certification, operation, maintenance, or long-term compliance of the facility.

Where any information provided by AIIMS Patna is considered indicative, insufficient, inconsistent, or requiring verification, the Bidder shall clearly mention the same in the Need Assessment Note.

(i) The fundamental philosophy underlying the design of the BSL-3 Laboratory at AIIMS Patna shall be to create a safe, compliant, functional, maintainable, validation-supportive and certification-ready high-containment laboratory facility that provides comprehensive, multi-layered protection to laboratory personnel, support staff, the institution, the community and the environment from exposure to high risk biological agents handled within the facility.

The A&E Consultant shall therefore develop the design after proper assessment of the existing building, available space, structural and service constraints, utility interfaces, equipment movement requirements, access conditions, maintainability requirements and regulatory compliance obligations.

The design shall not be treated merely as an interior fit-out, but as an integrated high-containment laboratory system.

The design shall incorporate reliable, testable and maintainable containment measures proportionate to the nature and level of risk.

(i) All work involving biological agents is carried out within appropriately selected, located, installed and certified biological safety cabinets or other containment equipment, as required by risk assessment and applicable guidelines;

(ii) The laboratory environment itself maintains appropriate negative pressure relationship with respect to adjacent non-containment areas, thereby creating inward airflow and preventing escape of potentially contaminated air;

(iii) Air movement, pressure cascade, door interlocks, airflow paths and room relationships are must be planned to support containment and minimize cross-contamination risk;

(iv) All exhaust air and other relevant air streams shall be treated through suitable HEPA filtration and containment-oriented engineering systems, as applicable.

UVGI may also be considered as a supplementary disinfection provision in HVAC/exhaust/air-treatment systems, wherever justified by biosafety expert & biosafety risk assessment and approved design philosophy; however, UVGI shall not be treated as a substitute for HEPA filtration, validated decontamination, cleaning, disinfection, commissioning or certification requirements.

(v) The layout must support correct use of PPE, controlled entry and exit, donning and doffing, shower / change procedures, emergency response and decontamination processes;

(vi) Emergency systems, alarms, communication systems, eyewash / safety shower provisions, spill response provisions and escape routes are appropriately planned and accessible; and

(vii) The design supports occupational health, incident response and laboratory-acquired infection prevention measures through appropriate infrastructure, documentation interfaces and operational planning inputs.