Statement of Work.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Spanish Speaking Neuropsychology Consulting Support Services

Statement of Need and Purpose:

The purpose of this requirement is acquisition of Spanish speaking neuropsychology consulting support services for diagnosis and management of patients referred to the NINDS for neurological consultation and for provision of research testing support as part of clinical protocols.

Background Information and Objective:

The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The NINDS Intramural Program in particular conducts clinical trials in epilepsy, dementia, movement disorders and neuroinflammation that require understanding the effects of the disorders and treatments on the neuropsychological capacities of patients in these studies.

Period of Performance:

The period of performance for this requirement shall be as follows:

Base: June 1, 2022 through May 31, 2023 Option 1: June 1, 2023 through May 31, 2024 Option 2: June 1, 2024 through May 31, 2025

The place of performance shall be the NIH Clinical Center located on 10 Center Drive, Room 6- 5700, Bethesda, Maryland, 20892. The contractor is required to work on-site.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, professional libabiltity insurance, 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 Spanish neuropsychology consulting support services:

• Perform Spanish neuropsychological testing of adults and children under the direction of Government staff. Testing shall include standard and customized tests of intelligence, personality, memory and learning for the diagnosis and treatment of adults and children in support of the NINDS intramural research program.

• Development of new protocol-specific tests related to the specific protocol(s) under study and the individual being tested. Customized testing may include computerized batteries designed to address specific patient abilities, such as reaction time testing, smell testing, or speech measures. The Contractor will utilize knowledge of a broad range of Spanish neuropsychological testing and current literature to advise Government staff on appropriate testing options for achieving the protocol goals.

• Conduct analysis and interpretation of test results consistent with best practices in the field of neuropsychology.

• Prepare written reports in accordance with Reporting Requirements below.

• Assist in collation of research results for publication according to the timeline requested by the Government staff.

• Perform intraoperative neuropsychological testing and intracarotid amytal (Wada) procedures under the direction of Government staff. The actual medical procedures shall be performed by physicians however the neuropsychology consultant shall provide materials and assess language and memory during the procedures.

LEVEL OF EFFORT:

The level of effort is estimated at one (1) contractor for a 100 labor hours during the base period of performance of this purchase order. 100 labor hours are estimated during each option.

GOVERNMENT RESPONSIBILITIES

The Government will provide scheduling support in arrangement of outpatient clinic rooms on an as needed basis. The Government will provide the contractor with a standard desk top computer. Contract employee will provide all necessary supplies for the various types of testing required. Supplies shall include tests, scoring manuals, test records, and response forms. At the present moment, no equipment is required. The Government will ensure that all protocols have Institutional Review Board (IRB) approval in place prior to testing human subjects.

DELIVERY OR DELIVERABLES

Deliverables Performance Standard

Acceptable Quality Level

Method Used/Frequency

Submission of reports In accordance with statement of work:As needed

98% Per Human Subject Evaluation

REPORTING REQUIREMENTS

Prepare written reportsfor every evaluation performed to include documentation of all neuropsychological and psychological tests administered, individual performance on the tests as compared with normative data, interpretation of the data based on best practices in the neuropsychology field, and numerical test data for individual patients.

OTHER CONSIDERATIONS

Travel:

Travel is not required or authorized for this contract. No travel costs shall be reimbursed.

Key Personnel:

The Contractor employee working under this award shall be considered key personnel. Key Personnel requirements are as follows:

• Must be fluent in Spanish and have at least 10 years’ experience in the methodology, design analysis, interpretation and reporting of diagnostic clinical neuropsychological tests in the research setting.

• Ability to design and customize neuropsychological tests and test panels specific to research needs of NINDS, as evidenced by inclusion as an investigator on one or more clinical protocol or publications.

• A minimum of 5 years experience in administering and interpretation of standard neuropsychological testing in adults and children.

• Must be a licensed Spanish Clinical Neuropsychologist and be ability to meet requirements for credentialing as adjunct medical staff by the NIH Clinical Center (per NIH Clinical Center Medical Administrative Policy M90-5).

• At least 10 years experience with intraoperative neuropsychological testing and intracarotid amytal testing in patients with epilepsy and other neurological disorders.

• Contractor must maintain credentialing by the NIH Clinical Center yearly and be up to date with certifications (CPR, Licenses renewals along with all other necessary credentialing material.) NINDS is the responsible party to ensure the necessary requirements.

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The following individual(s) is/are considered to be essential to the work being performed here under:

Name Title

To be determined in the contract award Neuropsychologist - Spanish Speaking

Information System Security Plan:

The Contractor must obtain approved access to the NIH campus and approved access to the clinical research database and folder on the intramural NINDS server. The Contractor will utilize NIH email and computers.

The Contractor shall comply with all applicable homeland Security regulations and procedures during the performance of this task order. Security and confidentiality of patient information must be observed according to the Federal Privacy Act. The contractor shall not disclose and must safeguard procurement sensitive information computer systems and data, privacy act data, and Government personnel work products that are obtained or generated in the performance of this task order. If necessary, the contractor will be required to provide clearances for personnel requiring access to Government computer and workstations.

NIH ID must be worn at all times when performing work. Work may be performed at bedside or in the intensive care unit. Universal precautions and infection control policies on the Clinical Center must be observed. The Contractor shall successfully complete the required on line training in such cases of toxic spills, hazardous situations and body fluid exposure.

Contractor shall be informed of the appropriate procedures for reporting any and all patient coded emergencies. These instructions include calling the emergency number 111, reporting the necessary information, the Unit, Room Number, and Phone Number; rather the patient is a child or adult. The caller will remain on the line until instructed otherwise via the emergency team at which time will instruct the caller to hang up and initiate Code Blue light; caller will then wait for emergency staff arrival.

Data Rights:

The NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. 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 shall be made a part of any resulting contract/order.

Section 508—Electronic and Information Technology Standards:

Not applicable

Publications and Publicity:

Not applicable

Confidentiality of Information:

The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

The Contractor shall abide by the Privacy Act of 1974 (5 U.S.C. § 552a) and protect sensitive data which includes patient medical records, contract information, financial and budget records and IP addresses.

Disclosure/download of information/data, in whole or in part, by the Contractor may only be made after the Contractor receives written approval from the Contracting Officer. Data shall not be downloaded to or stored on portable devices or outside systems without Government encryption. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.