Attachment 4 - Tech Eval Criteria.pdf

RFP No. 75N95024R00013

TECHNICAL EVALUATION CRITERIA

TITLE: THE NIH NATIONAL NEUROHIV TISSUE CONSORTIUM – NEW CLINICAL SITE

NOTE: FACTOR 1 BELOW EVALUATES THE QUANTITY, QUALITY AND CHARACTERISTICS OF

THE DONOR SPECIMENS THAT CAN REALISTICALLY BE ACQUIRED; FACTOR 2 BELOW

EVALUATES OTHER SITE FUNCTIONS, CAPABILITIES, PROCESSES AND PROCEDURES THAT

WILL BE UTILIZED.

The evaluation factors below will be used by the technical evaluation committee when reviewing the technical proposals. Proposals will be evaluated by a Technical Evaluation Panel according to the three (3) factors outlined below. All of the technical factors are weighted equally. Proposals will be evaluated based on the extent to which they provide confidence in accomplishing the functions delineated in the Statement of Work (SOW). Contractors are required to be able to perform the entire SOW.

The following adjectival confidence rating descriptions shall be used for the Technical Evaluation:

High Confidence -The Government has high confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract with little or no Government intervention.

Medium Confidence -The Government has some confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract with some Government intervention.

Low Confidence -The Government has low confidence that the Offeror understands the requirement, proposes a sound approach, or will be successful in performing the contract even with Government intervention.

Unacceptable -The proposal fails to recognize, address, or consider the Government’s requirements.

FACTOR 1:

ACQUISITION CAPABILITIES/CHARACTERISTICS OF DONOR SPECIMENS

The objective of this initiative is to establish a contract with a site that that can, on a continuous basis, collect a significant volume of high quality and high value HIV+ and HIV- donor specimens, including specimens with certain characteristics or clinical diagnosis and associated data. This section of the proposal should demonstrate the Offeror’s Acquisition Capabilities/Characteristics of Donor Specimens approach.

Offerors will be evaluated on a composite basis on their approach proposed/demonstrated ability to accomplish the following criteria:

a. PROJECTED COLLECTION SIZE

The ultimate, realistic, projected collection size at the end of a potential five-year contract period will be evaluated (consists of the inclusion of any high-quality current specimens donated to the repository for contract purposes as well as the projected acquisition capabilities).

(1) New Specimens: Acquire new brain donors each year. While, milestones will be determined in conjunction with the contractor to specify the numbers/types of brains to be collected per given period, offerors are expected to provide estimated numbers based on data

• Offerors shall provide evidence that supports a tentative/proposed new specimen acquisition schedule by either historical or other data. Contractors shall also provide recruitment capability evidence through historical records and/or a demonstration of having targeted outreach experience and plans (i.e., well-established mechanisms for recruiting and registering potential donors and experience with outreach efforts to appropriate HIV disease organizations and populations).

• Offerors shall demonstrate their ability to effectively acquire new donors each year, and to maximize the quality of available clinical data including evidence of well-established mechanisms for recruiting, pre-registering, and following potential HIV donors.

(2) Current Specimens for Inclusion (if applicable): Requires evidence of high-quality, well-characterized tissue, including quality metrics) (e.g., RIN, 260/280 ratio, tissue pH, etc.)

and supporting phenotypic data.

(3) Evidence that supports the proposed new specimen acquisition schedule by either historical or other data. Recruitment capability will be measured/evaluated by historical records and targeted outreach experience and plans (i.e., well-established mechanisms for recruiting and registering potential donors and experience with outreach efforts to appropriate HIV disease organizations and populations).

b. DONOR COLLECTION CHARACTERISTICS

Offerors will be evaluated on the probability of acquiring specimens with the following attributes/characteristics/data and the flexibility to acquire specific cases as determined by future initiatives:

(1) NeuroHIV Biobanking Donor specimens relevant to the scientific mission of the participating institutes supporting this project (including unaffected controls) are solicited under this contract (i.e., Office of AIDS Research (OAR), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Aging (NIA) and National Institute on Drug Abuse (NIDA))

Evaluation will be based on the following criteria:

• Offeror’s ability to acquire donors with HIV on Antiretroviral therapy

• Offeror’s ability to acquire appropriately matched HIV- controls

• Offeror’s capability and flexibility to target and acquire HIV+ and HIV- donor populations as determined by future NIH-HIV initiatives. The extent to which the offeror has specific expertise in NeuroHIV biobanking and are able to acquire as requested should be specified.

• Offeror’s ability to access unique or difficult to reach patient populations

(2) Clinical Data Donor specimens that are accompanied by rich demographic, genotypic, phenotypic, neuropathological and other types of clinical data are of the greatest value to the research community. Offeror will be evaluated on the ability to acquire donor clinical data including longitudinal clinical assessments to support specimen use.

The following types of associated antemortem and postmortem data are expected:

i. Clinical findings and clinical history, including ARV medication history

ii. Concomitant medication use

iii. Laboratory testing results

iv. Venous blood collection and testing collected for CBC, CD4+ T cell enumeration, plasma HIV load, and research samples of PBMC, serum, and plasma

v. CSF extraction and testing for white blood cell count, total protein, glucose, and HIV load

vi. Urine toxicology

vii. Neuromedical evaluation

viii. Neuropsychological testing and assessment

ix. Neuropsychiatric assessment that includes that include the CIDI, BDI or other equivalent batteries as well as questionnaires that include medication adherence and activities of daily living

x. Anthropomorphic measurements

xi. Demographics, including age, sex, gender, race, ethnicity

xii. Medical history updates, examinations, and laboratory tests should be repeated every 6 – 24 months depending on the participant’s health and/or likelihood of loss to follow-up

xiii. Tailored domain-based neuropsychological assessments data using the RDoC framework

xiv. Longitudinal neuroimaging data for study participants

xv. Longitudinal data pertaining to pathway-linked biological measures such as signaling pathways, neuroinflammation, and immune profiles

xvi. Measures of mechanistic biological signatures/targets to aid in diagnosis of and development of pre-clinical therapeutic interventions for CNS co-morbidities

xvii. Neuropathological indices, neuroimaging data, and biomarkers

xviii. Phenotypic information such as cranial MRI findings (deidentified images and/or reports), other radiological reports, results of genetic tests and/or diagnostic evaluations, other clinical notes, and evaluations by specialists

xix. Measures of viral dynamics in the CNS and the periphery, including state of the science assays to quantify viral reservoirs (IPDA, QVOA)

xx. Viral and host genetic data that could aid in neuropathogenesis research

xxi. Data related to aging associated co‐morbidities such as Alzheimer’s disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) (e.g., neuropsychological indices, neuroimaging data, biomarkers)

xxii. All of the above data resources in the context of substance use (nicotine, cocaine, methamphetamine, stimulants, opioids, prescription drugs, and cannabinoids)

xxiii. Neuropathologic evaluation, including histological categorization of human brain and spinal cord based on diagnostic protocols pre-established by the NNTC

xxiv. Neuropathologic evaluation specific to AD/ADRD)

xxv. HIV-related organ pathology

xxvi. Non-HIV-related organ Pathology

xxvii. Fluid collection, which may be performed during scheduled study visits or, if necessary, upon a participant’s demise xxviii. Cause and manner of death

xxix. Medications at the time of death (ATOD)

xxx. If unavailable during antemortem assessment and/or if contacted after an individual’s death:

a. Collection of family legal guardian’s consent for tissue donation and release of medical records

b. Collection of family history information such as date of birth, education level, ethnicity, medical problems, genetic disorders, and mental illness including substance use for first-degree relatives, when available.

(3) Other Criteria

i. Cohort diversity, including women and NIH defined minority health populations.

ii. Geographic distribution that includes donors from different geographical areas

iii. Donations of other non CNS/PNS tissues and antemortem fluids and biopsies

iv. Utilization of community engagement and participatory research approaches for longitudinal HIV cohort studies

FACTOR 2:

OTHER NNTC CLINICAL SITE CHARACTERISTICS/METHODS (STANDARDS,

SOPS, QUALITY ASSURANCE SYSTEMS), TISSUE ACQUISITION/REGULATIONS,

CURRENT INFRASTRUCTURE, AND DATA MANAGEMENT)

This section of the proposal should demonstrate the Offeror’s other NNTC clinical site characteristics/methods, tissue acquisition strategy, current infrastructure, data management approach, and tissue analysis approach. Offerors will be evaluated on an overall basis on their approach and proposed/demonstrated ability to provide the items below to successfully begin this Project upon award, without start-up delays.

a. General

(1) Methodology to acquire, track (including all daughter specimens), store, catalog, maintain, and distribute tissues required under this contract, in adherence to the highest ethical standards and state and federal regulations.

b. Standards

(1) Standard Operating Procedures. As evidenced by the Table of Contents from the SOP

Manual, appropriate types of SOPs are expected to be in place for all tasks, including preventing duplicate submissions. Methods for tissue distribution and sharing. Stated willingness to adopt standardized protocols and measures, when possible, and to modify existing SOPs accordingly.

(2) Quality Assurance Systems/Program/Plan

A comprehensive Quality Assurance/Management plan (QMP) to monitor the entire specimen management process, from specimen receipt to storage and distribution including documentation of data such as postmortem interval; specimen processing; monitoring of storage conditions at the box and freezer level; inspection of shipping containers and storage facilities, including the central alarm system, air conditioning systems, and the back-up power system; specimen quality data management; requisitioning; and shipping of all requested specimens.

The QMP should operate in an autonomous manner, separate from the technical staff, and report results directly to the contract Principal Investigator and/or other senior institutional or corporate management and to the NIMH COR.

(3) Regulatory

i. Indicate which Internal Review Board approves brain bank activities

ii. Evidence of Compliance with all applicable health and safety regulations

iii. Evidence of appropriate shipping licenses and permits from local, State, Federal and international authorities for the safe import, storage and distribution of biological specimens, according to current regulatory guidelines, as applicable.

c. Equipment/Storage/Freezers and other needed facilities.

Materials, equipment, and facilities are expected to be sufficient to successfully carry out the Project. This will include:

(1) Providing sufficient floor space and/or vertical storage for contract startup in a single facility to accommodate samples and equipment;

(2) Appropriate back-up systems as considered state-of-the-art for biobanking;

(3) Appropriate laboratory and office space; and

(4) Plans to accommodate the space and storage requirements for an increasing collection size throughout the contract.

d. Data Management Systems and Databases

Evidence of an adequate data management system/process to perform this Project.

A comprehensive Laboratory Information Management System (LIMS) for tracking, cataloging, photographing, digitally recording information about tissue quality and sample integrity. This system will be required to provide accurate inventory and associated data through a federated IT system referred to the NIH NNTC DCC, which will serve as the primary portal for researchers, and others in the general public interested in the NNTC’s services.

FACTOR 3: PERSONNEL

This section of the proposal should demonstrate the Offeror’s personnel. Offerors will be evaluated based on the quality, availability, and competence of the proposed personnel, management abilities, and efficiency of the staffing plan will be evaluated as follows:

a. Evidence of expertise and experience from years of work experience in the NeuroHIV field, as evidenced through publications in peer-reviewed scientific journals and history as a site investigator for a NeuroHIV program.

b. Knowledge of state-of-the-art methods for tracking, handling, characterizing, processing, and distributing human infectious tissue. As technological and methodological advances occur, demonstrated ability to propose and/or adopt new state-of-the-art procedures in NeuroHIV biospecimen and biorepository research for implementation in this contract.

c. Knowledge of cutting-edge scientific approaches/methods utilizing human post-mortem tissue, and ability to assess the landscape of needs of the NeuroHIV research community to refine collection, processing, and/or preservation approaches to accommodate these changes in technology and methodology.

d. Availability and necessary expertise for working with HIV populations and for coordinating antemortem clinical data and postmortem biospecimen data with a DCC for database management and maintenance.

e. Appropriateness and efficiency of the staffing plan to accomplish the work.

f. Ability to manage the project, ensure appropriate staffing, comply with all applicable laws and ethical standards.