Attachment 1 - SOW Human Brain Collection Children SOW 2022.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

NIMH Postmortem Human Brain Collection

Statement of Need and Purpose:

The Contractor shall provide contract services to the Human Brain Collection Core (HBCC) at the National Institute of Mental Health (NIMH), to acquire donor specimens for HBCC research purposes during the contract period, based upon the requirements outlined below. The services are to procure human postmortem brain tissue, including various other specimens (e.g., dura, hair, blood, pituitary) at autopsy, and provide these specimens to HBCC. The Contractor also provides information contained in the death investigation report and any other medical/toxicological information related to the donor. The donated postmortem human brain specimens will be used for research by the HBCC into the neurobiology of complex mental disorders, and also distributed to approved/qualified outside investigators for research.

Background Information and Objective:

The Human Brain Collection Core at the NIMH explores the causes, consequences, and potential treatments of numerous neurological and psychiatric disorders. HBCC research is supplemented by studying postmortem brain tissue from both psychiatrically healthy and afflicted individuals in order to establish the neuropathological changes underlying these complex neuropsychiatric disorders. This research will lead to improved diagnosis, treatment and/or prevention of these illnesses and their consequences.

Period of Performance:

The period of performance is one 12-month base year with four 12-month option years.

Base Year: 07/01/2022 – 06/30/2023 Option Year One: 07/01/2023 – 06/30/2024 Option Year Two: 07/01/2024 – 06/30/2025 Option Year Three: 07/01/2025 – 06/30/2026 Option Year Four: 07/01/2026 - 06//2027

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:

On a daily basis, the Contractor shall review case documents for potential donation and determine which cases may be eligible for HBCC research (see below for inclusion/exclusion criteria). Eligible cases include those with a reasonable suspicion of a history of mental or neurological illness, or as non-psychiatric controls across the lifespan. The HBCC shall obtain basic clinical histories or other collateral information that surface in the conduction of their routine investigation to help determine eligibility. Brains from ages up to eighteen, both sexes, and all races are eligible. Brains within a 150-mile radius from NIH Bethesda are eligible to be considered. Shipments must be received no later than 46 hours after death and within 6-8 hours after extraction which includes all the packing of the brain. This time requirement is necessary in order to minimize biochemical degradation of the tissue.

1. Inclusion criteria:

a. Brain tissue is needed from individuals suffering from a variety of neuropsychiatric disorders (including schizophrenia, anxiety disorders, suicide, bipolar disorder, and depression) and neuro-developmental disorders.

b. In addition, brains from individuals without a history of neuropsychiatric or developmental disease will be needed, particularly those who die at a very early age when no psychiatric condition can be assessed. These cases are key to the study of development.

c. Brains of individuals with genetic abnormalities that predispose to neuro-psychiatric conditions, including chromosomal aneuploidies.

2. Exclusion criteria:

a. History exclusive for substance use disorders (cocaine, alcohol, heroin, or the like). If there is indication of a concomitant disorder such as schizophrenia, a history of psychiatric hospitalization or there is a high suspicion that the individual died of suicide, the case will be referred to HBCC.

b. Infections known to affect the brain such as syphilis, tuberculosis, with the exception of HIV or COVID-19 infection.

c. The body is decomposed. We will consider collecting the brain if we can complete processing within 48 hours after death.

d. There is obvious damage to the brain by closed head injury or other trauma (gunshot wound, fall, etc.).

e. There are brain infarcts, hemorrhages, stroke, or other brain lesions that destroy the normal brain structure. We will collect primary brain tumors if the hospital agrees (optional).

f. The patient has been maintained on a respirator (ventilator) for more than 12 hours.

g. Major sepsis.

3. Once a case is identified/selected, the Contractor shall contact HBCC personnel and provide: 1) the general background of the case (name, demographics, circumstances of death, medical and social history); and 2) the name, relationship, and telephone number of the decedent’s next-of-kin.

4. It is important that the next-of-kin be notified of the death of their loved one prior to referral to HBCC.

5. HBCC inquires with all next-of-kin what their relationship to the decedent is and tries to determine in good faith whether the next-of-kin is indeed the legal primary decision maker regarding the brain donation.

6. HBCC staff will promptly contact the next-of-kin to obtain permission (via a recorded telephone call) and to obtain the deceased subject’s brain and skull contents for research (including dura, pituitary, blood, and hair sample). Other tissues may be requested at this time. HBCC staff will also solicit the release of medical records from decedent’s treatment facilities or medical and behavioral providers.

7. Extraction and Shipping

a. Once permission is obtained by HBCC personnel, the Contractor shall be notified by phone to procure the brain, 40-90 cc of blood, a nasopharyngeal swab for Sars-CoV-2 testing, and possibly other tissues at the time of autopsy.

The Contractor will begin extraction promptly upon notification of approval from the NIMH. The process should begin no later than within 24 hours of death; unless approved by the NIMH Project Officer and/or Contracting Officer’s Representative (COR). The Contractor will provide to the HBCC any relevant documents related to a specimen including cause and manner of death, relevant history and/or toxicology in order to allow optimal characterization of the specimen.

b. After extraction, the Contractor shall promptly prepare the specimens for shipping to the NIMH. An ice-making machine is required in order to pack the brain on ice for transportation. This will be provided by the Contractor and costs reimbursed through the contract. HBCC personnel will provide transportation of the samples to the NIH campus.

c. Prior to shipping, the NIMH shall be contacted with shipping details, including the courier tracking number.

d. Shipments must be received as soon as possible after extraction (no longer than 12 hours) which includes all the packing of the brain. In no case will specimens be accepted by NIMH beyond 46 hours after death (2 hours are required for processing); a much shorter time period is highly desirable. Delay in receiving the brain results in degradation of the tissue that makes it unsuitable for research.

e. The Contractor will ensure that specimens are packaged in accordance with all federal, state, and local regulations.

f. The Contractor will provide HBCC with a report on the Cause of Death of the individual as soon as this is generated.

LEVEL OF EFFORT:

It is very difficult to estimate the level of effort for this work. Our latest data related based on medical examiner referrals, indicate that a medical examiner performing 1,000 autopsies/year will refer 7-10% of autopsies to HBCC for consent, resulting in 50-100 referrals per year. 30- 60% of referrals result in a brain donation and therefore in approximately 25-30 brain extractions per site/year. We expect the number of referrals to be lower, given the more limited number of deaths occurring in a hospital setting, but the percentage of successful donations may be higher, given the relationship established between the institution and the next-of-kin, the number of referrals and successful donations is difficult to estimate and will vary from year to year. The Contractor has no control over the number of cases presented for autopsy, or those that may be suitable for inclusion into the NIMH Brain Bank, although they might be able to propose the possibility of autopsy and brain donation in cases that would not normally require it.

Use the following data as a basis for estimating the potential volume of referrals for each proposed site (adjust for your own circumstances, with justification):

-Provide an estimate of the number of annual referrals that may meet the inclusion criteria in the Statement of Work and include this information as part of your Technical Proposal (explain how it was calculated).

As a basis for preparing cost proposals, the Government estimates the following level of effort to provide these services, per site:

-Up to 240 hrs. effort, per year, per site, to provide all contract services (i.e., referrals, extractions, and for other contract communications and administration);

-It is anticipated that this effort should accommodate a wide range of contract services and volumes of referrals and extractions.

-This estimate is not a requirement, and the offeror can propose differences, with justification.

Some of the details of this SOW may change on renewal years of the contract to allow for unforeseen circumstances. The number of referrals and brain extractions may grow in subsequent option years. The contract allows for a potential future expansion of services provided by the Contractor.

GOVERNMENT RESPONSIBILITIES

HBCC will provide transportation of the specimens to the NIH campus in Bethesda, MD, by identifying the appropriate courier for contractors located within a 150-mile radius from the NIH campus. HBCC will pick up the brain from facilities located within a 50-mile radius from NIH.

Rare cases with schizophrenia, bipolar disorder, or children below the age of 15, will be referred to HBCC on weekends or on Federal Holidays. HBCC may provide coolers for transport, supplies to preserve the blood (tubes), supplies for testing for Sars-CoV-2 (swabs), or other equipment required for the extraction and preservation of the brain that would burden the Contractor with extra costs. The Contractor will not need access to government facilities.

Additionally, the Contractor will receive a neuropathological report from HBCC within 31 days of the extraction of the specimens delivered to the HBCC.

REPORTING REQUIREMENTS

See below under Deliverables.

DELIVERY OR DELIVERABLES

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with the

DELIVERIES Article of this contract:

1. Technical Progress Reports

a. All technical reports shall be submitted to the Contracting Officer’s Representative

(COR) electronically, in Microsoft Excel or Microsoft Word format. The Contracting

Officer shall also receive electronic copies of Final Technical Report, in addition to signed hard copies of each Annual Report and the Final Report. The specific content of technical reports will be determined by the COR, but it is not expected that reports will exceed 1 page in length. If options to extend the term of this contract are exercised, this reporting schedule will continue during any/all contract extensions.

b. All electronic reports submitted shall be compliant with Section 508 of the

Rehabilitation Act of 1973. Additional information about testing documents for

Section 508 compliance, including specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Helpful Resources."

c. Scheduled/Recurring Progress Reports

2. Annual Report(s)

Annual Reports shall be submitted to the COR within 15 calendar days after the end of each 12-month contract period. This report should include the number of referrals to HBCC, the number of donations that occurred in the previous year, and any problems that were experienced during the reporting period. This report shall be in sufficient detail to describe comprehensively the results achieved.

3. Final Report

i. This report is to include a summation of the work performed and results obtained for the entire contract period of performance.

ii. The Final Report shall be submitted in accordance with the http://www.hhs.gov/web/508/index.html

DELIVERIES Article of this contract. An Annual report will not be required for the period when the Final Report is due.

iii. If options to extend the term of this contract are exercised, Final Reports will be due at the end of the revised/extended period of performance.

OTHER CONSIDERATIONS:

Travel:

No travel is required by the Contractor.

Key Personnel:

Key personnel needed for this contract are:

Medical Examiner* or Pathologist if in a hospital setting Autopsy Technician*

As needed:

Medical Examiner- Investigator Administrator

Information System Security Plan:

The contractor is not required to access federal information systems. The contractor will communicate sensitive personal data to HBCC in a secure way (phone call or secure email).

Data Rights:

The National Institute of Mental Health shall have unlimited rights to and ownership of the data collection platform and all data including reports. 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.

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998 if appliable.

Publications and Publicity:

The contractor will not write or publish articles of data produced as a result of the requirements of the SOW.

Confidentiality of Information:

For this requirement, the government may provide to the contractor(s) information or data of a personal nature about individual(s) or proprietary information or data pertaining to this project, which is confidential. This requirement is expected to generate information or data which is confidential. The Contractor(s) shall handle all sensitive information or data in a secure manner and consult with the authorized government employee prior to any release, disclosure, dissemination, or publication.

Additionally, HBCC will provide a neuropathological report to the contractor in a timely fashion.

This information is expected to be part of the contractor’s report on the cause of death, and this information will be treated in conformity to local laws. It is the preference of the HBCC to receive the whole brain intact, however, it may be possible for the Contractor to retain some tissue in order to generate their own neuropathology report. If the Contractor chooses this option, HBCC will not be obligated to provide their own report.

HBCC will also provide the contractor with positive results of a nasopharyngeal swab for Sars- CoV-2. If the case is unexpectedly positive, the contractor is expected to notify the next-of-kin and all personnel that came in contact with the decedent within 24 hours of the receipt of this information, in order to allow for public health related measures.