NIA Lumbar Puncture Services - Statement of Work - GINC.pdf

Statement of Work (SOW)

A. GENERAL INFORMATION

1. Title of Project: Lumbar Puncture (LP) under fluoroscopic guidance (Fluoro-guided LP) or LP under ultrasound guidance (ultrasound-guided LP) of NIA Clinical Unit Participants

2. Background Information: The National Institute on Aging (NIA), one of the 27 Institutes and Centers of NIH, leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. The Intramural Research Program (IRP) of the National Institute on Aging (NIA) provides a stimulating setting for a comprehensive effort to understand aging through multidisciplinary investigator-initiated research, in this regard.

One of the IRP's program activities includes the Clinical Research Core (CRC) part of the NIA Clinical Unit within the Office of the Scientific Director. The CRC seeks to elucidate normative values and separate normal aging findings from disease states. The CRC’s goal is to prolong disease-free states with age. The CRC serves as an infrastructure to facilitate the creation and development of therapeutic targets for the treatment of age-related disease across the Intramural Research Program. The CRC performs research in various protocol studies that have direct clinical applications to aging and disease states. NIA recruits voluntary participants to take part in the various research protocol studies performed by the CRC staff. Part of a participants’ visit may include having Fluoro-guided lumbar puncture (LP) or Ultrasound-guided LP, typically after a bedside LP fails or is not deemed technically possible by the medical staff, to acquire Protocol-specified amounts of cerebrospinal fluid.

3. Purpose or Objective of the Requirement: The contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW).

The contractor shall provide Fluoro-guided LPs or ultrasound-guided LPs of research participants as required by the specific protocol.

4. Type of Contract Contemplated:

Contract, Open Market, and the expected value will be provided (inclusive of options)

5. Period of Performance: The period of performance is twelve months (12) from the date of award, plus four (4) one-year options.

B. CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

Independently and not as an agent of the Government, the Contractor shall be required to furnish qualified personnel and secure access and utilization of necessary specialized facilities and equipment, not otherwise provided by the Government, as needed to perform the tasks as specified herein. Specifically,

• Fluoro-guided LP or ultrasound-guided LP services shall be performed according to the standards of good clinical practices on research participants on an as-needed and priority basis under NIA IRP credentialed physicians’ or Nurse Practitioners’ orders and as authorized by the NIA Project Officer.

• For Fluoro-guided LP or ultrasound-guided LP, the Vendor acquires Protocol-specified amounts of cerebrospinal fluid and delivers them to NIA Investigators or Clinical staff.

• No Personally Identified Information is shared with the contractor beyond the name of the participant. In particular, no results of the testing of the CSF are shared with the contractor.

• Incumbent acknowledges it is a “covered entity” under the Health and Portability and Accountability Act of 1996 (HIPAA) and agree to comply with the requirements thereof, as well as all other applicable laws and regulations pertaining to patient privacy.

C. GOVERNMENT RESPONSIBILITIES

The Government will notify the Contractor when a research participant will likely need a LP under fluoroscopic guidance. Notification may range from one week in advance to day-of/as-needed notification.

D. DELIVERY OR DELIVERABLES

No written deliverables. Refer to the above scope of work in Section B. “Contractor Requirements (Scope of Work)”.

E. TRAVEL

Not applicable.

F. CONTRACTOR EXPERIENCE REQUIREMENTS – KEY PERSONNEL

1. The Radiologist(s) is considered "Key Personnel" in support of this contract initiative. The Radiologist(s) must demonstrate special expertise in Fluoro-guided LP or ultrasound-guided LP, by virtue of medical training, board certification in radiology, an active state-issued medical license.

2. The minimum education requirement for the key personnel is successful completion of a residency program in Radiology that has been approved by the Accreditation Council for Graduation Medical Education.

3. The Key personnel must hold at least one unrestricted valid license in a state, territory or commonwealth of the U.S. for a minimum of 1 year as required by the licensing board.

4. The key personnel must hold a current Advanced Cardiac Life Support Certification (ACLS)

5. The key personnel must hold a current Basic Cardiac Life Support (BLS) certification.

G. SECURITY REQUIREMENTS:

H. DATA RIGHTS

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data- General,” is hereby incorporated by reference and made a part of this contract/order.

I. SECTION 508 – ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS

J. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

1. The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

Name:

Dimitrios Kapogiannis, M.D.

Clinical Investigator Human Neuroscience Unit/Laboratory of Neurosciences National Institute on Aging (NIA/NIH) Phone: 410-350-3953 Email: Kapogiannisd@mail.nih.gov

2. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

3. The Contracting Officer is the only person with authority to act as agent of the

Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

4. The Government may unilaterally change the COR designation for this contract.