25-007718 Statement of Work (SOW).doc

STATEMENT OF WORK (SOW)

(SERVICES)

GENERAL INFORMATION

Title of Project:

Consensus Conference Research Diagnoses of Cognitive Impairment and Dementia in Participants in the Baltimore Longitudinal Study of Aging (BLSA) Statement of Need and Purpose:

The purpose of this acquisition is to procure neuropsychometric evaluation services for the National Institute on Aging (NIA) Laboratory of Behavioral Neuroscience (LBN).

Background Information and Objective:

The National Institute on aging (NIA), Laboratory of Behavioral Neuroscience(LBN) requires neuropsychometric evaluations performed using the Clinical Dementia Rating (CDR) scale on study participants in the Baltimore Longitudinal Study of Aging (BLSA). The evaluations will include scoring, rescoring, data entry and verification. The required services are in support of the Consensus Conference Research Diagnoses of Cognitive Impairment and Dementia in Participants in the BLSA. It is anticipated that this will involve 5 to 10 evaluations per week with each evaluation taking 30 minutes to one hour. A second goal is the preparation of summary information for joint NIA-Johns Hopkins consensus case conferences for these study participants, including data entry of diagnoses. A third goal is to perform neuropsychological/neurological assessments using the standard Early Markers neuropsychological battery and a neurological examination on study participants in the BLSA, who are in between regular BLSA visits or will not be seen by the BLSA home visit program. It is anticipated that this will involve 10 evaluations over the course of the contract with each evaluation taking 3-4 hours. If the participant consents, the neurological examination will be videotaped for review by the neurologist. In addition, this procurement may involve home visits of selected study participants where these would otherwise not be completed.

The LBN’s overall goal is to identify early markers of Alzheimer’s disease (AD) and cognitive impairment. LBN investigators perform cognitive and neuroimaging assessments in participants in the BLSA to investigate accelerated changes that are associated with cognitive decline and impairment and to identify predictors of cognitive impairment and cognitive resilience (maintenance of cognitive health). An important component of these investigations is the consensus diagnostic evaluation of participants within a research context. These consensus conferences utilize both participant and informant-based information on the cognitive health of participants, using the CDR, as well as summary medical, medication, neurological and neuropsychological assessment information on participants for evaluation by the case conference team, which includes both LBN and Johns Hopkins Staff.

Period of Performance:

September 30, 2025 to September 29, 2026.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

The Contractor shall provide the following services required to be performed at the NIA Research and Clinical Facilities or through home visits to participants:

· The contractor will perform 5 to 10 CDR scale evaluations per week on BLSA study participants, which will take 30 minutes to one hour each.

· The contractor will score and rescore the CDRs and enter and verify them in the xforms data entry system developed by the NIA.

· The contractor will prepare summary information for joint NIA-Johns Hopkins consensus case conferences for these study participants.

· The contractor will enter the consensus case conference results into an Excel spreadsheet and deliver it to the NIA Project Officer or representative after each case conference.

· The contractor will perform 5 to 10 home visit neuropsychological/neurological assessments on study participants (70 years and older) who either need to be seen in between their usual BLSA visits or who would otherwise not be seen by the BLSA home visit program.

· The contractor will score and rescore the neuropsychological assessments and enter and verify them in the xforms data entry system developed by the NIA.

· The contractor will review the videotapes of the neurological examination.

· The contractor will enter and verify the neurological examination in the xforms data entry system developed by the NIA.

LEVEL OF EFFORT:

The contractor will perform approximately 5-10 CDR scale evaluations per year performed by two (2) psychometricians. The BLSA study participants evaluations will take between 30 minutes and one hour each.

GOVERNMENT RESPONSIBILITIES

The Government will provide a list of study BLSA participants who have met the criteria for CDR administration and case conference review and a list and contact information for participants requiring home visits. All data provided to the consultant by the Government must be treated as confidential and not be disclosed to any third party.

NIA has an externally accessible website specifically to collect data. The contractor puts information into the website and NIA then uses this information for our research.The contractor has no access to NIA information. This is simply a one way transfer of data.

DELIVERY OR DELIVERABLES

· Hard copies of CDR scales administered to BLSA participants.

· Weekly to biweekly summary reports for availability at research case conferences.

· Electronic files containing data on CDR scales and research diagnoses based on research case conferences.

· Electronic files containing data on neuropsychological assessments and neurological examinations collected during home visits.

OTHER CONSIDERATIONS

Travel:

N/A Key Personnel:

Neurologist, Senior Researcher, Psychometrician

Information System Security Plan:

N/A Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. 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.

Confidentiality of Information:

The Contractor must guarantee strict confidentiality of the information/data that is provided by the NIA or by any other participant on a project to which the consultant is assigned. The NIA has determined that the information/data that the consultant will be provided during the performance of the consulting contract is of a sensitive nature.

The Contractor may only disclose the information/data generated as specified in the BLSA NIH Intramural IRB Protocol Number: 03-AG-0325.

Contractor agrees to not use Confidential Information for any purpose except as set forth within this SOW unless such time as such Confidential Information becomes public information.

Version 11-30-2016-1

FAR Part 11—Describing Agency Needs