The purpose of this Manual Chapter is to establish the policy, procedures, and guidelines to ensure an effective management structure is in place to plan, design, and support the construction requirements for the acquisition of specialized equipment at the National Institutes of Health (NIH) using Turnkey Operations.

This policy provides the guidelines, procedures, and the checks and balances necessary for the Office of Research Facilities Development and Operations (ORFDO) to maintain the integrity of NIH owned buildings and systems when Turnkey acquisitions are used to install specialized equipment in support of the NIH mission.

Public Health Service Act, 42 U.S.C. § 282(b)(4)(A) authorizes the Director of NIH on behalf of the Secretary of the Department of Health and Human Services (HHS), to acquire, construct, improve, repair, operate and maintain facilities and equipment on NIH campuses.

By authority of the Director of NIH, the Office of Research Facilities Development and Operations (ORFDO) is delegated the responsibility for:

1. The day-today maintenance, management and accountability for real property for which NIH is the holding agency, except as otherwise delegated¹;
2. To exercise administrative authorities related to engineering, facilities planning and construction, and direct Federal special-purpose construction activities²; and
3. To grant rights-of-entry for construction for Federal real property within the NIH’s jurisdiction³.

The planning, design, and construction activities that take place in NIH facilities to support the installation of specialized equipment warrant a cradle-to-grave management structure. Institutes, Centers and Offices (ICOs) Subject Matter Experts (SMEs) are required to address the specialized equipment operations. The ORFDO technical experts manage the building and infrastructure needs to support the special purpose equipment and associated research.

The installation and operation of major medical and scientific equipment often require changes to walls, structures, or utilities. The ORFDO’s engineers and architects must be involved throughout the life of Turnkey Acquisitions to ensure the availability and reliability of buildings and the infrastructure to support these acquisitions, and to reduce potential risk to the health and safety of patients, the public, accreditation(s), and the NIH mission.

^{1 Delegation of Authority (DoA), Property: Real, No. 04: Maintenance, Management and Accountability of Real Property}

^{2 DoA, Property: Real, No. 06: Engineering and Facility Management Services}

To ensure efficient, effective and reliable operations of NIH buildings and the supporting infrastructure are maintained for Turnkey procurement actions, ICOs must establish a Memorandum of Understanding (MOU) with ORFDO, agreeing to:

1. Identify an ICO Contracting Officer Representative (COR) for each procurement;
2. Only the COR and CO can provide guidance to vendor and changes are made solely by the cognizant contracting officer.
3. Include the ORFDO identified Project Officer as the technical expert to address the building infrastructure requirements to work with the official contract COR;
4. Adhere to the NIH Design Requirements Manual;
5. Adhere to ORFDO’s Building Permitting Process;
6. Adhere to ORFDO’s Project Management Desk Guide for Design and Construction Projects; and to
7. Include the requirements of Items 1 - 6 above in the acquisition plan supporting the procurement action.

1. Requester: Responsible for initiating the procurement request and obtaining the required clearances or technical coordination from the ORFDO as noted herein and as listed in Appendix 2.
2. Head of the IC Program Office: Responsible for:
   1. Developing a MOU with ORFDO agreeing to comply with ORFDO’s design, building, permitting and project management guidelines;
   2. Signing the MOU with ORFDO; and
   3. Obtaining the ORFDO Director’s signature approving the MOU.
3. Chief of the ICO Contracting Office: Responsible for concurring with the IC/ORFDO MOU to comply with ORFDO’s design, building, permitting and project management guidelines.
4. ICO Contracting Officer’s Representative (COR): Responsible for performing the specific technical or administrative functions delegated in writing by the Contracting Officer and is the sole technical point of contact with vendors to address equipment functional requirements identified in Appendix 2.
5. ORFDO Project Officer (PO): Responsible for working with the COR to ensure the Turnkey procurement follows ORFDO’s planning, design, construction and commissioning guidelines identified in Appendix 2.
6. Office of Research Facilities Development and Operations (ORFDO): Responsible for identifying to the ICO, the proposed ORFDO Project Officer to coordinate with the contract COR regarding the building and facilities interface requirements for Turnkey acquisitions consistent with the facility stewardship roles identified in Appendix 2, and for charging a Fee for Service based on the cost of construction.

1. The ICO submits a Request for Construction Project Service to ORFDO to obtain technical support and the applicable HHS, ORFDO, and the Office of Research Services (ORS) acquisition clearances identified in Appendix 2.
2. ORFDO assigns a PO to coordinate technical requirements with the identified COR and charges a Fee for Service based on the cost of construction.
3. The Head of the Program Office signs and issues the MOU officially acknowledging ORFDO’s cradle-to-grave responsibility to manage NIH buildings to ensure the availability and reliability of those assets to support Turnkey Acquisitions. The MOU shall state that:
   1. All parties understand that ORFDO has a responsibility to be a good steward of NIH owned facilities;
   2. ORFDO understands that ICO’s within NIH may procure equipment from a commercial vendor or other agencies through an Interagency Agreement (IAA), such as Magnetic Resonance Imaging (MRI) systems, to advance scientific discoveries;
   3. When such procurements involve design or impact real property, ORFDO must be involved consistent with the roles and responsibilities identified in Appendix 2;
   4. The COR must consult with ORFDO’s PO as the subject matter expert regarding design and construction matters;
   5. Failure of all parties to approve the MOU in advance of the procurement will absolve ORFDO of responsibility for costs resulting from the need to modify real property assets; and
   6. Failure to adhere to the procedures in this manual chapter, whether intentional or through negligence, will result in the ICO being responsible for any and all cost, both direct and incidental, to remediate the damage caused to NIH equipment and buildings in accordance with NIH Policy Manual 26307-31-Institutes, Centers and Offices (ICOs) Equipment and Building Damage Compensation Policy.
4. ORFDO’s Director signs the MOU and returns it to the Head of the IC Program Office.
5. The Chief of the ICO Contracting Office reviews the MOU and provides the necessary support to meet the needs of the Program Office.
6. A template for the MOU is included as Appendix 3.

1. The Economy Act (31 U.S.C. 1535)
2. Federal Acquisition Regulations (FAR) subpart 17.5
3. Federal Acquisition Regulations (FAR) 1.602-2
4. Health and Human Services Program Manual, (Volume 1), Section 2-3 HHS Facility Project Approval Agreements (FPAA)
5. NIH Delegations of Authority, Real Property, Number 4 – Maintenance, Management and Accountability of Real Property
6. NIH Delegation of Authority, Real Property, Number 06 – Engineering and Facility Management Services
7. NIH Delegation of Authority, Real Property, Number 06A – Construction Management
8. NIH Manual Chapter 1165 – Agency Agreements
9. NIH Manual Chapter 1370 - Fire Protection and Life Safety Building Permit Process
10. NIH Manual Chapter 1743 – Keeping and Destroying Records
11. NIH Manual Chapter 6307-3-Special Clearance and Other Acquisition Procedures
12. NIH Manual Chapter 26307-31 – Institutes, Centers and Offices (ICOs) Equipment and Building Damage Compensation Policy
13. Office of Research Facilities Division of Technical Resources (DTR) Permit Review (accessible by permission)
14. NIH Facilities Development Manual Section 3-10-Clinical Center Complex (CCC) Interim Life Safety Measures (ILSMs) and Construction Risk Assessment (CRA)
15. NIH Design Requirements Manual