NBB Toxicology Testing Services - Statement of Work.pdf

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

National Institutes of Health (NIH) NeuroBioBank (NBB) Tissue Toxicology Testing Services

Statement of Need and Purpose:

The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Institute of Mental Health (NIMH), and the NIH NeuroBioBank (NBB), has a requirement for postmortem human tissue toxicology testing services.

The National Institutes of Health (NIH) NeuroBioBank (NBB), supported by the National Institute of Mental Health (NIMH), National Institute of Neurological Diseases and Stroke (NINDS), National Institute on Aging (NIA), National Institute on Drug Abuse (NIDA), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the NIH Blueprint is a network of Brain and Tissue Repositories (BTRs) that are federated through an IT Portal (www.neurobiobank.nih.gov). NBB’s mission is to increase coordination and sharing of valuable tissue and data resources to support biomedical and translational neuroscience research. Since its inception in 2013, the NIH NBB has sought to identify ways to centralize services to enhance standardization thereby limiting the variability of specimens obtained from different BTRs. One way is to provide a centralized toxicology testing services for all brains acquired by the network BTRs.

Background Information and Objective:

The NIH Neurobiobank seeks to make well-characterized postmortem human brain tissue and biospecimens more widely available to support biomedical research on neurological, psychiatric, neurodevelopmental, and substance use and abuse disorders.

The goal of the Neurobiobank tissue toxicology testing services is to provide toxicology screening services to detect the presence and abundance of drugs of abuse, therapeutic drugs, and environmental toxins in human postmortem tissues, including brain, blood, and hair (See Appendix One for examples). These data will be provided back to the NIH NeuroBioBank IT contractor and will constitute a component of the phenotypic characterization of these tissues which will accompany the donor’s demographic, clinical and pathological data. More importantly this information will inform the design of the scientific investigations undertaken by researchers receiving tissues from the NeuroBioBank.

Period of Performance:

The period of performance shall be for a period of four (4) years.

http://www.neurobiobank.nih.gov/

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:

1. The Contractor shall furnish all the necessary labor (qualified and experienced personnel), services, material, equipment, supplies, and facilities, not otherwise provided by the Government, as needed to perform the requirements set forth below and shall use state-of-the-art methodologies and protocols to achieve all of the requirements.

2. As directed by the COR, the Contractor shall work cooperatively with each BTR to receive regular shipments of biospecimens (e.g., tissue, blood, hair) and to provide toxicological analysis and quantitative read-outs on an as-needed basis throughout the contract.

3. A decision matrix will be used by the NBB BTRs, and the COR to determine, on a case-by-case basis, which toxicology screens will be performed. This will be conducted in a tiered manner on an as needed basis such that not all tests will be done on all tissues or donors. All tests shall be approved by the COR in advance.

Specific Requirements:

1. Receipt of Samples (Shipping and Receiving and Process/Procedures) The process for receiving samples and return of data to BTR, Neurobiobank, and the NIMH COR is summarized as follows:

a. The Contractor shall receive anonymized samples shipped from the NBB BTRs on a schedule that will be agreed on with the Contractor after the award.

b. The Contractor shall use a chain of custody tracking process to assure that assay results are ascribed to the correct sample.

c. The Contractor shall employ the appropriate assays for specified analyses as directed by the NBB BTR and the COR.

d. The Contractor shall return the assay results to the NBB BTR and to the COR or the COR’s designee on a monthly basis.

2. Toxicological Assays of Human Biospecimens

a. The Contractor shall assay human tissues (primarily post-mortem brain tissue, but also blood and hair) for different drugs (therapeutic and drugs of abuse), (see Appendix One).

b. The Contractor shall be expected to perform a combination of assays on a given tissue, or to assess a particular drug in multiple tissue types (e.g., blood, brain, and hair) according to the needs of the BTRs requesting services and NIH Neurobiobank programmatic priorities, as directed by the COR. The majority of agents to be tested under this program will be therapeutic agents, psychotropic drugs, or drugs of abuse.

c. The Contractor shall be expected to perform confirmatory assays to verify inconclusive findings.

d. Depending on assay complexity, the Contractor shall complete testing within 14 to 28 business days after receiving samples.

e. The Contractor shall destroy all samples following their assay as directed by the COR in accordance with Industry standards.

f. The Contractor shall use state of the art operating procedures for tissue tracking, storage, analysis, and biohazard disposal.

3. Data Management

a. On a monthly basis, the contractor shall provide quantitative results of all toxicological testing performed to the NBB BTR and to the COR or to the COR’s designee(s).

b. These results should be provided electronically on a monthly basis, using a file format and transfer protocol to be determined by the COR. The contractor shall ensure the security and confidentiality of all specimen data throughout its lifecycle (e.g. receipt of the specimens through delivery of quantitative results).

c. The Contractor shall maintain a secure, cumulative electronic database of toxicology test results for no more than one month after data has been returned to the COR or their designee. After one month, results must be archived in a secure database and only made available with permission from the COR until COR directs the results be deleted permanently, or the termination of this contract.

LEVEL OF EFFORT:

The Government anticipates awarding a single-award Indefinite Delivery / Indefinite Quantity (IDIQ) contract type with payment based on the fully loaded unit prices.

a. Delivery of supplies and/or performance of services shall be made only as authorized by individual delivery/task orders issued in accordance with Section 1.6: Ordering Procedures.

b. The Government will order up to the maximum aggregate amount of $2,984,229 and the minimum aggregate amount of $25,000 for the contract four (4) years’ period of performance.

There is no limit on the number of orders that the Government may issue.

GOVERNMENT RESPONSIBILITIES

All services will be carried out at the contractor site and will not require access to government facilities or equipment.

DELIVERY OR DELIVERABLES

The Contractor shall provide quarterly, yearly, and final Tissue Analysis Reports (with the corresponding regularly scheduled Technical reports) that document and summarize the results of performance. This report shall be in sufficient detail to describe number and types of analyses done, by test, sample, and donor.

REPORTING REQUIREMENTS

Reporting Deliverables

Deliverable

Description

Format & Method of Delivery

Frequency or Due Date

Study Reports

- The quantitative findings from all protocols in which a given compound was evaluated, including each tissue analyzed shall be submitted. A final report of all cases and tissues analyzed should be provided.

- The report formatting may be revised and should include a cover page that includes title, sub-contract number, authors, laboratory address, dates of initiation and completion, and sponsor;

a table of contents; and a statement prepared and signed by the Contractor’s Quality Assurance Unit which will refer to all phases of the study and indicate where the raw data records, reports and samples are stored. This shall also include results, statistical analysis, statistical evaluation, graphs, and appendices (as needed).

Electronic copy via file transfer protocol to COR’s designee (currently Information Management Services)

Monthly

Quarterly Progress Reports

- Quarterly reports summarizing the status of assays performed and in progress shall be provided to the COR at quarterly intervals. These reports shall detail the specific toxicology analyses performed on each tissue, for each donor, and the status of any incomplete tests. These reports shall be due on the 30th calendar day of each quarter.

copy via email to

COR

Quarterly

Annual Reports - The Contractor shall submit an annual report that provides a summary of the work accomplished during each contract period. Annual Reports shall be submitted 30 calendar days after the anniversary date of the contract.

Annual Reports shall follow the format described above for the quarterly Progress Reports. The Annual Report shall have a cover title page and appropriate summary and conclusion sections that cover all the studies included.

copy via email to

COR

Annually

Final Reports - The Contractor shall submit a final report that documents and summarizes the results of the entire contract period of performance. This report shall be in sufficient detail to describe number and types of analyses done, by test, sample, and donor

Electronic copy via email to

COR

.OTHER CONSIDERATIONS

Travel:

No travel reimbursement costs are authorized under this contract.

Key Personnel:

The key personnel shall be 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 essential to work performance. At least thirty

(30) days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor(s) 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. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor(s) shall provide the maximum notice practicable under the circumstances. The Contractor(s) 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) are essential to the work being performed here under:

Name Title

To be Determined Program Manager

To be Determined Manager of Laboratory Studies

It is required that all contractors involved with the National Institute of Mental Health (NIMH) community work collaboratively with federal staff and other contractors towards the Institute’s mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s) while providing services as outlined in the Statement of Work. The written consent and approval of any other non-related SOW direction provided to the contractor shall stem only from the Contracting Officer. This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required.

Information System Security Plan:

The Contractor shall secure and protect all Contractor-owned property and equipment brought into Government facilities during performance of work under this contract. The Government shall not be held liable for loss of or damage to Contractor-owned property or equipment brought into Government facilities. The Contractor shall remove any Contractor-owned property deemed inappropriate by the Government, for any reason, from the Government facility in which it is found.

1. Any computer used in relation to this contract must be patched with the most updated IT Security Patches.

2. Any Contractor computer used in relation this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis.

3. Hard drives and portable media used for this contract must be encrypted using the FIPS 140- 2 standard.

4. Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/

5. Contractor are required to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf.

6. Contractors are required to report any lost or stolen NIH data to the NIMH Information Systems Security Officer (ISSO) within one hour of knowing of the lost or theft even if the data is on a Contractor furnished computer.

7. Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

8. Any computers used in reference to this contract must be assessed for vulnerabilities.

9. Any computers used in reference to this contract must be backed up on an external hard drive which is password protected.

10. Any computers used in reference to this contract must have auditing enabled such that if an incident occurred then that event could be reconstructed.

11. Any computers that are used in reference to this contract must employ at a minimum username and password authentication or, if possible, two factor authentication.

12. Any computer used in relation to this contract must be passphrase protected. All passphrases must meet the NIH standard such that users must choose passphrase that have at least 15 characters and at least three of the following types of characters:

a. uppercase letters

b. lowercase letters http://irtsectraining.nih.gov/ http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf

c. words

d. spaces

Data Rights:

The National Institute of Mental Health (NIMH) shall have unlimited rights to and ownership of all deliverables provided under this contract, including reports, analyses, recommendations, briefings, work plans, software, 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 made a part of this contract.

Section 508—Electronic and Information Technology Standards:

Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies’ electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board’s Web site at https://www.access-board.gov/508.htm. Unless it is an “undue burden” or compliant products or services do not exist, the products must conform to Section 508. The Contractor must state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception.

The Contractor shall deliver all written products intended for posting to the NIMH internet in compliance with Translation and Interpretation Services (TIS) for the disabled. For more information regarding the HHS 508 policies and standards please review the following website:

http://www.hhs.gov/web/policies/pdfaccessibility/whycomply.html.

Publications and Publicity:

If the Contractor has a desire to publish any articles that contain any information and/or data gathered during the SOW contract period, the Contractor must submit the formal request in writing, which shall require signature by the NIMH Director, or someone delegated by the NIMH Director, granting permission for any publishing rights. At no point in time is it acceptable for the Contractor to include any PII in any publications the Contractor desires to make public.

Confidentiality of Information:

Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

Confidential Information or records shall not be disclosed by the Contractor(s) without written authorization from the Contracting Officer. Whenever the Contractor(s) is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor(s) should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

All data provided to the Contractor and generated by the Contractor under this contract must be treated confidentially. The data to be treated confidentially is associated not only with the http://www.hhs.gov/web/policies/pdfaccessibility/whycomply.html submitted identifier but also with all test results. Under no circumstance are the sample identifier, tissue type, or the data generated under this contract, to be released or divulged to the public.

The Government requires that all data accumulated under the projected contract be immediately available for its review and that provisions be made to maintain confidentiality of all data.

Authority to release data may be granted only by the COR and must be in writing.

Appendix for Confidentiality and Nondisclosure Agreement and Incoming MTA between Contractor and BTRs. An active copy must be shared with the COR.

Appendix One

REPRESENTATIVE LIST OF ANALYTES

10-Hydroxycarbazepine Acetaminophen Acetone Acetyl Fentanyl Alfentanil alpha-PVP Amitriptyline Amlodipine Amobarbital Amoxapine Amphetamine Atomoxetine Atropine Benzodiazepines Benztropine Beta-Phenethylamine Brompheniramine Bupivacaine Buprenorphine / Metabolite Bupropion Bupropion Metabolite Buspirone Butabarbital Butalbital Butorphanol

BZP

Caffeine Cannabinoids Carbamazepine Carbromal Carisoprodol Chlorpromazine Citalopram / Escitalopram Clomipramine Clonidine Clozapine Cocaine / Metabolites Cotinine Cyclobenzaprine Descarboethoxyloratadine Desipramine Desmethylcitalopram Desmethylclomipramine Desmethyldoxepin Desmethylmirtazapine Desmethylsertraline Desmethyltrimipramine Dextro / Levo Methorphan

Dextrorphan / Levorphanol Dicyclomine Diltiazem Diphenhydramine Donepezil Doxepin Doxylamine Duloxetine Duloxetine Breakdown Product

EDDP

Ephedrine / Pseudoephedrine Eszopiclone / Zopiclone Breakdown Ethanol Ethinamate Ethosuximide Ethotoin Ethylecgonine Ethylmorphine Etomidate Felbamate Fentanyl Flecainide Fluconazole Fluoxetine Fluvoxamine Gabapentin Breakdown Product Guaifenesin Haloperidol Hexobarbital Hydroxybupropion Hydroxychloroquine Hydroxyzine Ibuprofen Imipramine Isopropanol Ketamine Lacosamide Lamotrigine Laudanosine Levamisole Levetiracetam Lidocaine Loratadine Loxapine Maprotiline mCPP

MDA

MDEA

MDMA

MDPV

Meclizine Memantine Meperidine Mephedrone Mepivacaine Meprobamate Mescaline Mesoridazine Metaxalone Methadone Methamphetamine Methanol Methaqualone Methocarbamol Methoxetamine Methylecgonine Methylone Methylphenidate Metoclopramide Metoprolol Metronidazole Mexiletine Milnacipran Mirtazapine Monoethylglycinexylidide (MEGX) N-Acetylprocainamide Naltrexone - Free Naproxen Naproxen Breakdown Product Nicotine Nifedipine Norclozapine Norcodeine Norcyclobenzaprine Norfentanyl Norfluoxetine Norhydroxyzine Norketamine Normeperidine Norpseudoephedrine / Phenylpropanolamine Nortriptyline O-Desmethylvenlafaxine Ondansetron Opiates Orphenadrine Other Findings Oxycodone / Oxymorphone Papaverine

Paroxetine Pentazocine Pentobarbital Phencyclidine Pheniramine Phenobarbital Phensuximide Phentermine Phenylethylmalonamide (PEMA) Phenyltoloxamine Phenytoin

PMA

Primidone Procainamide Promazine Promethazine Propofol Propoxyphene Protriptyline Pyrilamine Quetiapine Quinidine Quinine Ramelteon Ramelteon M-II Rufinamide Salicylates Secobarbital Sertraline Strychnine Sufentanil Tetrahydrozoline

TFMPP

Theobromine Theophylline Thioridazine Thiothixene Ticlopidine Tiletamine Tramadol Tramadol Metabolite Trazodone Trihexyphenidyl Trimethoprim Trimipramine Venlafaxine Venlafaxine Metabolite Verapamil Xylazine Yohimbine Zaleplon

Zolazepam Zolpidem

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